Autonomic neuropathy contributes to the pathophysiology of diabetic gastroenteropathy, which impacts the entire gastrointestinal tract alongside pancreatic and gallbladder functions. This is evident in the widespread morphological remodelling of the enteric nervous system, smooth muscle cells, interstitial cells of Cajal and vascular supply, causing pan-enteric motor, sensory and secretory disturbances. The gastrointestinal symptoms caused by these changes are often burdensome and non-specific and frequently coexist with poor glycaemic management and even malnutrition, impacting quality of life negatively. The Gastroparesis Cardinal Symptom Index and the Gastrointestinal Symptom Rating Scale are validated questionnaires for assessing gastrointestinal symptoms. However, clinical supplementary objective measures are essential. Transit time assessments are frequently used and typically evaluated using gastric emptying scintigraphy, breath tests or colonic radiopaque markers, but they cannot measure contractile activity or fluid transport. The primary treatment goals are to prevent further disease progression and to obtain symptomatic relief. Treatments include improved glycaemic management and dietary modifications, while pharmacological treatments target gastrointestinal symptoms, small intestinal bacterial overgrowth and exocrine pancreatic insufficiency. Invasive interventions may involve gastric peroral pyloromyotomy or the implantation of a gastric neurostimulator to manage pharmacologically refractory gastroparesis. This review describes the prevalence, pathophysiology, clinical presentation, assessment and treatment of diabetic gastrointestinal dysfunction within each segment of the gastrointestinal tract and directly connected exocrine organs.

Chronic nausea and vomiting are symptoms of a wide range of gastrointestinal and non-gastrointestinal conditions. Diagnosis can be challenging and requires a systematic and well-structured approach. If the initial investigation for structural, toxic and metabolic disorders is negative, digestive motility and gut-brain interaction disorders should be assessed. United European Gastroenterology (UEG) and the European Society for Neurogastroenterology and Motility (ESNM) identified the need for an updated, evidence-based clinical guideline for the management of chronic nausea and vomiting.

A multidisciplinary team of experts in the field, including European specialists and national societies, participated in the development of the guideline. Relevant questions were addressed through a literature review and statements were developed and voted on according to a Delphi process.

Ninety-eight statements were identified and voted following the Delphi process. Overall agreement was high, although the grade of scientific evidence was low in many areas. Disagreement was more evident for some pharmacological treatment options. A diagnostic algorithm was developed, focussing on the differentiating features between gastrointestinal motility and gut-brain interaction disorders with predominant nausea and vomiting.

These guidelines provide an evidence-based framework for the evaluation and treatment of patients with chronic nausea and vomiting.

To establish a consensus on the definition and management of idiopathic gastroparesis, international experts (selected by neurogastroenterology and motility societies and initiated by the Rome Foundation) devised 144 statements using the Delphi method, with at least 80% agreement required. This consensus defined idiopathic gastroparesis as the presence of symptoms associated with delayed gastric emptying in the absence of mechanical obstruction. Nausea and vomiting were identified as cardinal symptoms. Frequently co-existing symptoms are early satiation and postprandial fullness. Diagnosis requires the presence of these symptoms alongside delayed gastric emptying, measured by a 4 h scintigraphy or gastric emptying breath test of a mixed composition meal in the absence of mechanical obstruction. Therapeutic options with proven efficacy were sparse. Dietary adjustments, nutritional support (per guidelines from the European Society for Clinical Nutrition and Metabolism for substantial weight loss or intractable vomiting), and opioid cessation were recommended by a consensus opinion. Antiemetic and prokinetic agents were also considered potentially beneficial. This consensus offers a global perspective on idiopathic gastroparesis.

High-frequency electrical stimulation therapy (gastric electrical stimulation, GES) is a treatment option for gastroparesis of various genesis. The best indication and prognostic parameters have not yet been conclusively determined.Retrospective analysis of all gastroparesis patients implanted with a GES device between 2011 and 2020. Clinical response was measured before and after implantation using a validated Gastroparesis Cardinal Symptom Index (GCSI) (maximum score: 5, minimum score: 0). Other study endpoints included: subjective symptom course (no improvement, partial improvement, or severe improvement) and change in gastroparesis medication.A GES device was implanted in 42 patients (16 M: 26 F, mean age 45 years). The etiology of gastroparesis was diabetic (n=23), idiopathic (n=10) or postoperative (n=9). Eleven patients (26%) had undergone one or more invasive treatments before. GCSI score of the total group was 3.23 preoperatively. The median follow-up time was 12 months. In the overall group, significant improvement in GCSI score was found 3, 6, 9, and 12 months postoperatively-regardless of indication. In multivariate analysis, disease duration of >30 months was associated with a significantly decreased GCSI score at 12 months (p<0.001). Approximately 40% of patients were able to discontinue or significantly reduce gastroparesis medication. At the end of follow-up, 81% of patients reported partial or major improvement in symptoms. During the follow-up period, three patients (7%) died.Gastric electrical neurostimulation is an effective and safe option for refractory gastroparesis-regardless of the underlying disease.

Acute pancreatitis (AP) is often accompanied by gastrointestinal motility disorders. The purpose of this study was to investigate the efficacy and possible mechanism of transcutaneous gastric pacing (TGP) in early-stage AP patients.

Sixty-five AP patients were randomly divided into conventional treatment group and TGP group. The serum ghrelin and vasoactive intestinal peptide (VIP) were used to assess the possible gastrointestinal hormonal mechanism involved. The parameters of electrogastrogram (EGG) were used to evaluate the gastric motility in AP patients. The first defecation time was used to assess the recovery of intestinal motility. The heart rate variability (HRV) test was performed to assess autonomic nervous function.

Compared with the conventional treatment group, the TGP treatment significantly improved symptoms in early AP patients, and shortened the first defecation time (p < 0.05) and the hospital days (p < 0.05). The level of VIP (P < 0.05) was also decreased in TGP group. The percentage of normal gastric slow waves (GSWS) (p < 0.05) was increased. The interleukin (IL)-6 level was decreased (P < 0.05). Concurrently, the vagal activity (HF) was increased (p < 0.01), the sympathetic activity (LF) was decreased (p < 0.01), and the ratio of sympathetic vagal (LF/HF) was decreased (p < 0.01).

The TGP treatment significantly improves the clinical symptoms in early AP patients. It also increases the percentage of normal GSWS. The therapeutic effect of TGP may be caused by autonomic nervous function mechanisms.

Gastric per-oral endoscopic myotomy (G-POEM) is a new therapeutic option for the treatment of refractory gastroparesis. However, the outcome of G-POEM after the failure of gastric electrical stimulation (GES) or other pylorus-targeting therapies has been poorly reported.

Data were collected from patients referred for G-POEM for refractory gastroparesis. The efficacy in patients with previous interventional techniques was compared to patients naïve to instrumental technique. The primary endpoint was the 6-month clinical success rate, defined as at least a 1-point decrease in the Gastroparesis Cardinal Symptom Index (GCSI).

Among 48 patients referred for G-POEM, 32 patients had previous instrumental treatments (66%): 15 (31%) had GES, and 17 (35%) had pyloric endoscopic dilation or toxin injection. The technical success rate was 100%. At 6 months, clinical success was achieved in 25/48 patients (52%) and the GCSI decreased from 3.38 (2.94-3.95) to 2.25 (1.11-3.36) (p < 0.001). The 6-month success rate was similar in patients with or without previous instrumental treatment (50.0% vs 56.3%; p = 0.41). The complication rate was also similar in the two groups (6.3% vs 12.5%; p = 0.59), with only one severe adverse event. The only predictive factor for success at 6 months was a higher body mass index (OR = 1.14 [1.01-1.32]; p = 0.05).

G-POEM is safe and remains effective after GES or previous pyloric treatment failure, with 50% efficacy at 6 months. The therapeutic strategy in refractory gastroparesis remains to be defined.

Gastroparesis is a disorder of delayed gastric emptying with associated symptoms of postprandial fullness, early satiety, nausea, vomiting, bloating, and abdominal pain. Functional dyspepsia is an upper gastrointestinal disorder of gut-brain interaction that presents with similar symptoms but is defined according to symptom patterns rather than gastric motor dysfunction. Although delayed gastric emptying is a defining feature of gastroparesis, other aspects of gastric neuromuscular dysfunction, such as gastric accommodation and visceral hypersensitivity might contribute to symptoms. Similarly, although functional dyspepsia is not defined by impaired gastric emptying, disordered gastric motility might underlie pathogenesis in some patients with functional dyspepsia. In the last decade, it has been increasingly recognised that these two disorders might represent varying presentations along a common continuum of neuromuscular dysfunction, although with differentiating features with respect to outcomes, diagnosis, and treatments. In this Review, an overview of gastroparesis and functional dyspepsia from the perspective of gastric motility is provided, discussing what is distinct and what is shared between these disorders.

Pyloroplasty is an effective surgery for gastroparesis. However, some patients fail to improve after pyloric drainage and may require subsequent gastric electric stimulation. There is a paucity of data on the efficacy of gastric stimulator as an adjunct to failed pyloroplasty. This study aimed to describe our experience with pyloroplasty, determine the efficacy of gastric stimulator for failed pyloroplasty, and compare the final outcomes of those who required pyloroplasty with and without gastric stimulator for gastroparesis.

Records of patients who underwent primary pyloroplasty for gastroparesis at our institution were reviewed. Patients with poor symptomatic improvement after pyloroplasty underwent subsequent gastric stimulator. Symptoms were assessed using the gastroparesis cardinal symptom index (GCSI) preoperatively and after each surgery. Severe gastroparesis was defined as GCSI total score ≥3. Outcomes were assessed after pyloroplasty in all patients and after stimulator in patients who failed pyloroplasty. Final outcomes were then compared between those who did and did not require adjunct gastric stimulator.

The study population consisted of 104 patients (89.4% females) with a mean (SD) age of 42.2 years (11) and body mass index of 26.9 kg/m2 (7). Gastroparesis etiologies were 71.2% idiopathic, 17.3% diabetic, and 11.5% postsurgical. At 18.7 months (12) after pyloroplasty, there was a decrease in the GCSI total score (3.5 [1] to 2.7 [1.2]; P = .0012) and the rate of severe gastroparesis (71.9%-29.3%; P < .0001). Gastric emptying scintigraphy (GES) 4-hour retention decreased (36.5 [24] to 15.3 [18]; P = .0003). Adjunct gastric stimulator was required by 30 patients (28.8%) owing to suboptimal outcomes with no improvement in GCSI (P = .201) or GES (P = .320). These patients were younger (40.5 [10.6] vs 49.6 [15.2] years; P = .0016), with higher baseline GCSI total scores (4.3 [0.7] vs 3.7 [1.1]; P < .001) and more severe gastroparesis (100% vs 55.6%; P < .001). All other preoperative characteristics were similar. At 21.7 months (15) after gastric stimulator, there was improvement in GCSI (4.1 [0.7] to 2.6 [1.1]; P < .0001), severe gastroparesis (100%-33.3%; P < .0001), and GES 4-hour retention (21.2 [22] to 7.6 [10]; P = .054). Before gastric stimulator, those who failed pyloroplasty had significantly worse GCSI (P = .0009) and GES (P = .048). However, after gastric stimulator, GCSI and GES improved and were comparable with those who only required pyloroplasty (P > .05).

Pyloroplasty improved gastroparesis symptoms and gastric emptying, yet 28% failed, requiring gastric stimulator. Younger patients and those with preoperative GCSI scores ≥3 were more likely to fail. Gastric stimulator improved outcomes after failed pyloroplasty, with comparable final GCSI and GES with those who did not fail.

Surgical treatments of refractory gastroparesis include pyloromyotomy and gastric electrical stimulator (GES). It is unclear if patients may benefit from a combined approach with concomitant GES and pyloromyotomy.

Retrospective cohort analysis of all patients with refractory gastroparesis treated with GES implantation with and without concomitant pyloromyotomy at Cleveland Clinic Florida from January 2003 to January 2023. Primary endpoint was efficacy (clinical response duration and success rate) and secondary endpoints included safety (postoperative morbidity) and length of stay. Success rate was defined as the absence of one of the following reinterventions during follow-up: Roux-en-Y gastric bypass (RYGB), pyloromyotomy, GES removal.

During a period of 20 years, 134 patients were treated with GES implantation. Three patients with history of previous surgical pyloromyotomy or RYGB were excluded from the analysis. Median follow-up was 31 months (IQR 10, 72). Forty patients (30.5%) had GES with pyloromyotomy, whereas 91 (69.5%) did not have pyloromyotomy. Most of the patients had idiopathic (n = 68, 51.9%) or diabetic (n = 58, 43.3%) gastroparesis. Except for preoperative use of opioids (47.5 vs 14.3%; p < 0.001), patient's characteristics were similar in both groups. There were no significant differences between the two groups in terms of overall postoperative complications (17.5% vs 14.3%; p = 0.610), major postoperative complications (0% vs 2.2%; p = 1), and length of stay (2(IQR 1, 2) vs 2(IQR 1, 3) days; p = 0.068). At 5 years, success rate was higher in patients with than without pyloromyotomy however not statistically significant (82% versus 62%, p = 0.066). Especially patients with diabetic gastroparesis seemed to benefit from pyloromyotomy during GES (100% versus 67%, p = 0.053). In an adjusted Cox regression, GES implantation without pyloromyotomy was associated with a 2.66 times higher risk of treatment failure compared to GES implantation with pyloromyotomy (HR 2.66, 95% CI 1.03-6.94, p = 0.044).

Pyloromyotomy during GES implantation for gastroparesis seems to be associated with a longer clinical response with similar postoperative morbidity and length of hospital stay than GES without pyloromyotomy. Patient with diabetic gastroparesis might benefit from a combination of GES implantation and pyloromyotomy.

Gastroparesis that is refractory to standard dietary and medical management may benefit from surgical treatment with gastric electrical neurostimulation, which has shown promise in reducing symptoms of the disease. Pyloroplasty may serve an adjunctive role to a gastric stimulator, but the precise benefit remains unclear. The present study compares reported rates of symptom improvement following gastric neurostimulator implantation with and without pyloroplasty.

A single center retrospective analysis of consecutive patients who received operative management for symptom refractory gastroparesis from 1 January 2020 to 31 December 2021 was performed. Subjects were assigned to cohorts based on treatment with gastric electrical stimulation alone (GES-only) or combined with pyloroplasty (GES + PP). A survey-based assessment was administered post-operatively that evaluated cardinal symptoms of gastroparesis (nausea, vomiting, early satiety) before and after treatment.

In total, 42 patients (15 GES-only, 27 GES + PP) were included in the study. Both groups reported a high degree of improvement in global symptom control following surgery (93% vs 81%) with no differences between treatment cohorts (p = 0.09). Early satiety demonstrated better improvement in patients who received gastric stimulation alone (p = 0.012). Subgroup analysis of diabetic gastroparesis patients showed a 2.2% decrease in hemoglobin A1c levels in the GES + PP group (p-0.034).

Symptom reduction in refractory gastroparesis appears to improve after placement of a gastric neurostimulator with or without the addition of a pyloroplasty procedure.

The treatment of gastroparesis can be difficult in everyday clinical practice. The aim of this anonymous survey of members of the Arbeitsgemeinschaft Leitender Gastroenterologischer Krankenhausärzte e.V. (ALGK) was to investigate the management of gastroparesis care in Germany.

The ALGK conducted a member survey using a standardized anonymous questionnaire including 11 questions from 14.04.2023 to 29.04.2023. The questions covered diagnostic and therapeutic procedures as well as various aspects of the management of gastroparesis.

The response rate was 21.4% (62 members). Only 6.56% of all respondents assessed the prevalence of gastroparesis correctly as estimated by current epidemiological publications. 68.85 % of all respondents used gastric emptying scintigraphy for diagnosis. 51.61% regarded an individualized therapy as the most important treatment goal, taking into account etiology and impact of symptoms, compared to symptomatic treatment of leading clinical symptom in 43,55 %. First choice treatment was medical treatment in 41.94%, dietary recommendations in 27.42% and endoscopic interventions in 24.2%. 100% of respondents used prokinetics, 40.32% used antiemetics while only 4.84% used analgesics. Insufficient availability of medical treatment options represents a need of action for 85.48%, compared to lacking official approval of available drugs for this indication for 48,39% of all respondents. Treatment options with little evidence were used quite frequently (e.g. use of herbal therapies in 43.55%).

Overall, the frequency of gastroparesis was underestimated in the current survey. Endoscopic options are quite often used as first-line treatment. Although symptom-guided treatment is important for the majority of respondents, prokinetics are predominantly used.

Ingestible electronics have the capacity to transform our ability to effectively diagnose and potentially treat a broad set of conditions. Current applications could be significantly enhanced by addressing poor electrode-tissue contact, lack of navigation, short dwell time, and limited battery life. Here we report the development of an ingestible, battery-free, and tissue-adhering robotic interface (IngRI) for non-invasive and chronic electrostimulation of the gut, which addresses challenges associated with contact, navigation, retention, and powering (C-N-R-P) faced by existing ingestibles. We show that near-field inductive coupling operating near 13.56 MHz was sufficient to power and modulate the IngRI to deliver therapeutically relevant electrostimulation, which can be further enhanced by a bio-inspired, hydrogel-enabled adhesive interface. In swine models, we demonstrated the electrical interaction of IngRI with the gastric mucosa by recording conductive signaling from the subcutaneous space. We further observed changes in plasma ghrelin levels, the "hunger hormone," while IngRI was activated in vivo, demonstrating its clinical potential in regulating appetite and treating other endocrine conditions. The results of this study suggest that concepts inspired by soft and wireless skin-interfacing electronic devices can be applied to ingestible electronics with potential clinical applications for evaluating and treating gastrointestinal conditions.

Electrical stimulation of the gut has been investigated in recent decades with a view to treating various gastro-intestinal motility disorders including, among others, gastric electrical stimulation to relieve nausea and vomiting associated with gastroparesis and sacral neuromodulation to treat fecal incontinence and/or constipation. Although their symptomatic efficacy has been ascertained by randomized controlled trials, their mechanisms of action are not fully understood.

This review summarizes the past year's literature on the mechanisms of action of gut electrical stimulation therapies, including their impact on the gut-brain axis.

Gastroparesis (GP) can be a severe and debilitating disease. Its pathophysiology is complex and not completely understood. Two principal mechanisms are responsible for the development of symptoms - gastric hypomotility and pylorospasm. Pylorus targeted therapies aim to decrease presumably elevated pyloric tone - pylorospasm. There is a growing body of evidence about their role in the treatment algorithm of GP. G-POEM (endoscopic pyloromyotomy) is an extensively studied pylorus targeted therapy. Its efficacy ranges between 56 and 80% and the number of recurrences among those with treatment effect seems low. G-POEM is a safe procedure with very low frequency of severe adverse events. At present, G-POEM should not be considered as an experimental approach and may be offered to all patients with refractory and severe GP. Nevertheless, G-POEM is not a first line treatment. Conservative measures such as diet modification and pharmacotherapy should always be tried before G-POEM is considered. Further research must focus on better patient selection as at present there are no standardized criteria. Functional imaging such as impedance planimetry (EndoFlip) may hold promise in this regard.

The motility of the gastrointestinal tract is coordinated in part by rhythmic slow waves, and disrupted slow-wave patterns are linked to functional motility disorders. At present, there are no treatment strategies that primarily target slow-wave activity. This study assessed the use of pacing to suppress glucagon-induced slow-wave dysrhythmias in the small intestine. Slow waves in the jejunum were mapped in vivo using a high-resolution surface-contact electrode array in pigs (n = 7). Glucagon was intravenously administered to induce hyperglycemia. Slow-wave propagation patterns were categorized into antegrade, retrograde, collision, pacemaker, and uncoupled activity. Slow-wave characteristics such as period, amplitude, and speed were also quantified. Postglucagon infusion, pacing was applied at 4 mA and 8 mA and the resulting slow waves were quantified spatiotemporally. Antegrade propagation was dominant throughout all stages with a prevalence of 55 ± 38% at baseline. However, glucagon infusion resulted in a substantial and significant increase in uncoupled slow waves from 10 ± 8% to 30 ± 12% (P = 0.004) without significantly altering the prevalence of other slow-wave patterns. Slow-wave frequency, amplitude, and speed remained unchanged. Pacing, particularly at 8 mA, significantly suppressed dysrhythmic slow-wave patterns and achieved more effective spatial entrainment (85%) compared with 4 mA (46%, P = 0.039). This study defined the effect of glucagon on jejunal slow waves and identified uncoupling as a key dysrhythmia signature. Pacing effectively entrained rhythmic activity and suppressed dysrhythmias, highlighting the potential of pacing for gastrointestinal disorders associated with slow-wave abnormalities.NEW & NOTEWORTHY Glucagon was infused in pigs to induce hyperglycemia and the resulting slow-wave response in the intact jejunum was defined in high resolution for the first time. Subsequently, with pacing, the glucagon-induced dysrhythmias were suppressed and spatially entrained for the first time with a success rate of 85%. The ability to suppress slow-wave dysrhythmias through pacing is promising in treating motility disorders that are associated with intestinal dysrhythmias.

Pacing has been proposed as a therapy to restore function in motility disorders associated with electrical dysrhythmias. The spatial response of bioelectrical activity in the small intestine to pacing is poorly understood due to a lack of high-resolution investigations. This study systematically varied pacing parameters to determine the optimal settings for the spatial entrainment of slow wave activity in the jejunum. An electrode array was developed to allow simultaneous pacing and high-resolution mapping of the small intestine. Pacing parameters including pulse-width (50, 100 ms), pulse-amplitude (2, 4, 8 mA) and pacing electrode orientation (antegrade, retrograde, circumferential) were systematically varied and applied to the jejunum (n = 15 pigs). Pulse-amplitudes of 4 mA (p = 0.012) and 8 mA (p = 0.002) were more effective than 2 mA in achieving spatial entrainment while pulse-widths of 50 ms and 100 ms had comparable effects (p = 0.125). A pulse-width of 100 ms and a pulse-amplitude of 4 mA were determined to be most effective for slow wave entrainment when paced in the antegrade or circumferential direction with a success rate of greater than 75%. These settings can be applied in chronic studies to evaluate the long-term efficacy of pacing, a critical aspect in determining its therapeutic potential.

Diabetic gastroparesis (DGp) is a common and preventable complication of uncontrolled diabetes mellitus (D.M.) and significantly affects the Quality of Life of patients. Diagnosis and management present as a clinical challenge due to the disease's complexity and limited effective therapeutic options. This review aims to comprehensively outline the pathogenesis, diagnosis, and management of diabetic gastroparesis, evaluating evolving approaches to guide clinicians and provide future recommendations.

A literature review was conducted on scholarly databases of PubMed, Google Scholar, Scopus and Web of Science encompassing published articles, gray literature and relevant clinical guidelines. Data were synthesized and analyzed to provide a comprehensive overview of diabetic gastroparesis, focusing on pathogenesis, diagnosis, and management.

The review intricately explores the pathogenesis contributing to diabetic gastroparesis, emphasizing autonomic neuropathy, oxidative stress, inflammation, hormonal dysregulation, microbiota alterations, and gastrointestinal neuropathy. Primary management strategies are underscored, including lifestyle modifications, symptom relief, and glycemic control. The discussion encompasses pharmacological and surgical options, highlighting the importance of a multidisciplinary approach involving various healthcare professionals for comprehensive patient care.

This review offers a thorough understanding of pathogenesis, diagnosis, and management of diabetic gastroparesis, underlining evolving approaches for clinicians. A multidisciplinary approach is crucial to address both the physical and mental health aspects of diabetes and its complications.

The evaluation of visceral hypersensitivity and gastric accommodation in patients with gastroparesis (GP) is difficult. CT-scan gastric volumetry allows to test the distension of different regions of the stomach. We aimed to study gastric volumes and patient's sensitivity to gastric distension between in patients with GP compared to patients with GERD.

Retrospective study including patients who had CT-scan volumetry for GP or GERD. Two CT-scan series were made after gastric distension: left lateral decubitus 30° (LLD30) for antrum and right lateral decubitus (RLD) for body. Pain and discomfort were assessed using visual analogue scale (VAS). Gastric volumes were measured for LLD30 and RLD.

13 patients (7 GP and 6 GERD) were included. Mean age was 35.6+/-7.3 years. Median gastric volume in the RLD was lower in GP vs GERD (927+/-208 ml vs. 1115+/-163 ml; p = 0.046) while it was similar for LLD30 (1053+/-228 ml vs. 1054+/-193 ml; p = 0.603). GP patients had significantly more pain and discomfort during the procedure: pain VAS for GP was 6[0-9] versus 0[0-2] for GERD, p = 0.004, discomfort VAS for GP was 7[4-10] versus 4[0-5] for GERD, p = 0.007. 66.7% of GERD patients felt no pain vs. 14.3% in GP, p = 0.053.

This pilot study suggests that GP could be associated with a reduced gastric volume compared to GERD in RLD after gaseous distension. In contrast, patient self-assessment of pain related to gastric distension was greater int GP patients. A lack of fundus accommodation and visceral hypersensitivity could explain some mechanisms in the genesis of GP symptoms.

Compromised bowel function is associated with a range of motility disorders such as post-operative ileus and chronic intestinal pseudo-obstruction. Disordered or weak motility compromise the efficient movement of luminal contents necessary for digestion and nutrient absorption. This study investigated the potential of high-energy pacing to enhance contractions in the proximal jejunum of the small intestine.

Pacing pulse parameters (pulse-width: 100 ms, 200 ms, 400 ms, pulse-amplitude: 4 mA, 6 mA, 8 mA) were systematically varied in the in vivo porcine jejunum (n = 7) and the induced contractile responses were evaluated using a video mapping system. Localized segmental contractions were quantified by measuring the intestinal diameter and thereby computing the strain. The impact of pacing parameters on contractile strain was investigated. Finally, histological studies were conducted on paced tissue to assess for potential tissue damage.

Segmental contractions were successfully induced at all pulse-settings and evaluated across 67 pacing sessions. In response to pacing, the intestine segment at the site of pacing contracted, with diameter reduced by 6-18%. Contractile response significantly increased with increasing pulse-amplitude. However, with increasing pulse-width, the increase in contractile response was significant only between 100 ms and 400 ms. Histology showed no tissue damage occurred when maximal pacing energy (pulse-amplitude = 4-8 mA, pulse-width = 400 ms, 5 minute duration) was applied.

High-energy pacing induced periodic segmental contractions in response to pacing pulses and the contractile strain was proportional to the energy applied on the intestine. The ability to enhance motility through pacing may hold promising therapeutic potential for bowel disorders and awaits clinical translation.

Small intestine pacing elicits localized segmental contractions which increase in magnitude with increasing pulse settings. This study marks the first adaptation of video mapping techniques to track the pacing response in the small intestine.

Functional gastrointestinal disorders (FGIDs) are common, and they severely impair an individual's quality of life. The mechanism of pathogenesis and the effective treatments for FGIDs remain elusive. Neuromodulation-a relatively new treatment-has exhibited a good therapeutic effect on FGIDs, although there are different methods for different symptoms of FGIDs.

We used PubMed to review the history of neuromodulation for the treatment of FGIDs and to review several recently proposed neuromodulation approaches with improved effects on FGIDs.

Electroacupuncture, transcutaneous electroacupuncture, transcutaneous auricular vagal nerve stimulation, sacral nerve stimulation (SNS) (which relies on vagal nerve stimulation), and gastric electrical stimulation (which works through the modulation of slow waves generated by the interstitial cells of Cajal), in addition to the noninvasive neurostimulation alternative approach method of SNS-tibial nerve stimulation and transcutaneous electrical stimulation (which is still in its infancy), are some of the proposed neuromodulation approaches with improved effects on FGIDs. This review has discussed some critical issues related to the selection of stimulation parameters and the underlying mechanism and attempts to outline future research directions backed by the existing literature.

The effects of gastric electrical stimulation are not fully understood. We aimed to assess the efficacy of gastric electrical stimulation (GES) for patients with gastroparesis and gastroparesis-like symptoms.

We searched PubMed, Scopus, Cochrane, Web of Science, Embase, and Science Direct to identify controlled trials and cohort studies. We used random effects models to estimate pooled effects. A total of nine studies met the criteria and were included for the final qualitative synthesis and the quantitative analysis. We examined the mean absolute differences (MD) and 95% CIs.

Nine studies (n = 730) met the criteria and were included for the final qualitative synthesis and the quantitative analysis. There was significant improvement in gastrointestinal (GI) total symptom score (TSS) with the GES group compared with controls during the randomized blind trials. This effect was sustained at 12 months after treatment compared with before treatment (MD = -6.07; 95% CI, -4.5 to -7.65; p < 0.00001). The pooled effect estimate showed a significant improvement in frequency of weekly vomiting episodes at 12 months compared with before treatment (MD = -15.59; 95% CI, -10.29 to -20.9; p < 0.00001).

GES appears beneficial, with significant improvement in GI TSS, weekly vomiting frequency, gastric emptying study, and quality of life.

Pediatric gastrointestinal motility disorders represent some of the most challenging clinical conditions with largely undefined pathogenetic pathways and therefore limited therapeutic options. Herein, we provide an overview of the recent advances in treatment options for these disorders and their clinical impact.

PubMed and Medline databases were searched for relevant articles related to the treatment of achalasia, esophageal atresia, gastroparesis, PIPO and constipation published between 2017 and 2022. In this article, we review and summarize recent advances in management of gastrointestinal motility disorders in children with a particular focus on emerging therapies as well as novel diagnostic modalities that help guide their application or develop new, more targeted treatments.

Gastrointestinal motility disorders represent one of the most challenging conundrums in pediatric age and despite significant advances in investigative tools, the palette of treatment options remain limited. Overall, while pharmacological options have failed to bring a curative solution, recent advances in minimal invasive therapeutic and diagnostic techniques have emerged as potential keys to symptom and quality of life improvement, such as ENDOFLIP, POEM, cine-MRI, fecal microbiota transplantation.

Gastric electrical stimulation (GES) is an effective therapy in medically refractory chronic nausea and vomiting. GES is assumed to be a contraindication for pregnancy. We examined the safety of GES during pregnancy and its clinical impact on vomiting symptoms.

A retrospective study was performed in two tertiary centers including all female patients of childbearing age implanted with GES. Patients without pregnancy while on GES were asked about their desire and concerns about pregnancy. Patients who were pregnant while on GES therapy were interviewed about the course of the pregnancy and labor, as well as the health of the children.

Among 91 patients implanted at childbearing age, 54 patients without pregnancy answered the questionnaire. Nine patients (16.7%) reported a desire for pregnancy and five patients (7.4%) reported worries about the safety of GES during pregnancy. Sixteen pregnancies were reported in 10 patients. All pregnancies ended in a live birth with premature birth in 12 pregnancies (75.0%). No health concern was currently noted in these children. No severe GES-related complications occurred during pregnancy with only pain at the implantation site reported during 3 pregnancies (18.8%). The severity and frequency of nausea and vomiting significantly increased during the first trimester (p = 0.04 and p = 0.005, respectively) and decreased after the delivery, becoming lower than before the pregnancy (p = 0.044 and p = 0.011, respectively).

Patients are concerned regarding pregnancy while being treated with GES. No serious maternal or fetal complications related to GES were noted in our cohort.

Abnormal slow-wave activity has been associated with functional motility disorders. Gastric pacing has been investigated to correct slow-wave abnormalities, but clinical therapies are yet to be established. This study aimed to define optimal parameters to advance the application of gastric pacing.

High-resolution gastric mapping was utilized to evaluate four pacing parameters in in-vivo pig studies: (i) orientation of the pacing electrodes (longitudinal vs circumferential), (ii) pacing energy (900 vs 10,000 ms mA2), (iii) the pacing location (corpus vs antrum), and (iv) pacing period (between 12 and 36 s).

The probability of slow-wave initiation and entrainment with the pacing electrodes oriented longitudinally was significantly higher than with electrodes orientated circumferentially (86 vs 10%). High-energy pacing accelerated entrainment over the entire mapped field compared to low-energy pacing (3.1±1.5 vs 7.3±2.4 impulses, p < 0.001). Regardless of the location of the pacing site, the new site of slow-wave initiation was always located 4-12 mm away from the pacing site, between the greater curvature and negative pacing electrode. A pacing period between 14-30 s resulted in stable slow-wave initiation and entrainment.

These data will now inform effective application of gastric pacing in future studies, including human translation.

Postoperative ileus and chronic intestinal pseudo-obstruction are intestinal motility disorders that can compromise bowel function resulting in a significant reduction in quality of life and prolonged hospital stays. While medication and nutritional support provides relief for some patients, a significant patient population remains untreated. Therefore, alternative treatment options are required. A novel framework that enables small intestine pacing and video mapping of the contractile response was developed. Pacing pulse parameters (pulse-period: 2.7, 10 s, pulse-width: 100, 400 ms, and pulse-amplitude: 4, 6, 8 mA) were systematically varied to investigate the effect of pacing on the small intestine contractility. The contractile response was quantified by computing the strain of the intestinal diameter at the pacing site. The framework was applied in vivo on porcine jejunal loops (n=4) where segmental contractions were induced in response to pacing pulses. Strain increased with increasing pulse-amplitude and pulse-width, while pacing at a period of 2.7 s elicited higher contractile strains compared to pacing at a period of 10 s at all settings (e.g., -0.18 ± 0.06 vs 0.12 ± 0.06 at 8 mA, 400 ms). For a pulse-width of 100 ms, the contractile strain continued to increase with increasing pulse-amplitude, while the induced strain was comparable for all pulse-amplitudes when paced with high pulse-width (400 ms). Therefore, pacing is an effective tool in modulating the intensity of segmental contractions.Clinical Relevance- Different pacing parameters can define contraction intensity and frequency in the small intestine. This is of therapeutic potential for treating motility disorders such as post-operative ileus and chronic intestinal pseudo-obstruction.

Gastroparesis (GP), a historically vexing disorder characterized by symptoms of nausea, vomiting, abdominal pain, early satiety, and/or bloating, in the setting of an objective delay in gastric emptying, is often difficult to treat and carries a tremendous burden on the quality of patients' lives, as well as the healthcare system in general. Though the etiology of GP has been fairly well defined, much work has been done recently to better understand the pathophysiology of GP, as well as to identify novel effective and safe treatment options. As our understanding of GP has evolved, many myths and misconceptions still abound in this rapidly changing field. The goal of this review is to identify myths and misconceptions regarding the etiology, pathophysiology, diagnosis, and treatment of GP, in the context of the latest research findings which have shaped our current understanding of GP. Recognition and dispelling of such myths and misconceptions is critical to moving the field forward and ultimately advancing the clinical management of what will hopefully become a better understood and more manageable disorder in the future.

Gastroparesis is a complex, challenging gastrointestinal disorder presenting with upper gastrointestinal symptoms, especially nausea and vomiting, with significant impact on patients' quality of life. After ruling out mechanical obstruction, it is essential to identify delay in gastric emptying for definitive diagnosis. The most common causes are idiopathic (no identified etiology), diabetes mellitus, and postsurgical status. Management of gastroparesis focuses on dietary modifications and treatment directed to symptom relief. Unfortunately, approximately one-third of patients are refractory to pharmacological therapy, and the effectiveness of the few nonpharmacological options has been questioned.

Extensive review of the literature identifies several uncertainties or controversies regarding the differential diagnosis based on the spectrum of symptoms, the lack of availability of reliable diagnostic test, and questions regarding effective therapeutic options. In this review, we discuss ten controversies regarding gastroparesis: clinical presentation, diagnosis, overlap syndromes, pathophysiology, etiology, as well as pharmacological and nonpharmacological therapeutic options. In addition, we briefly review studies exploring pathological, inflammatory, and molecular disturbances affecting the intrinsic neuromuscular elements that may be involved in the pathophysiology of gastroparesis and may constitute possible therapeutic targets in the future. Finally, we tabulate future research opportunities to resolve these controversies in the management of patients with gastroparesis.

The gut-brain axis, which is mediated via enteric and central neurohormonal signaling, is known to regulate a broad set of physiological functions from feeding to emotional behavior. Various pharmaceuticals and surgical interventions, such as motility agents and bariatric surgery, are used to modulate this axis. Such approaches, however, are associated with off-target effects or post-procedure recovery time and expose patients to substantial risks. Electrical stimulation has also been used to attempt to modulate the gut-brain axis with greater spatial and temporal resolution. Electrical stimulation of the gastrointestinal (GI) tract, however, has generally required invasive intervention for electrode placement on serosal tissue. Stimulating mucosal tissue remains challenging because of the presence of gastric and intestinal fluid, which can influence the effectiveness of local luminal stimulation. Here, we report the development of a bioinspired ingestible fluid-wicking capsule for active stimulation and hormone modulation (FLASH) capable of rapidly wicking fluid and locally stimulating mucosal tissue, resulting in systemic modulation of an orexigenic GI hormone. Drawing inspiration from Moloch horridus, the "thorny devil" lizard with water-wicking skin, we developed a capsule surface capable of displacing fluid. We characterized the stimulation parameters for modulation of various GI hormones in a porcine model and applied these parameters to an ingestible capsule system. FLASH can be orally administered to modulate GI hormones and is safely excreted with no adverse effects in porcine models. We anticipate that this device could be used to treat metabolic, GI, and neuropsychiatric disorders noninvasively with minimal off-target effects.

The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update (CPU) is to review the available evidence and provide expert advice regarding cognitive, procedural, and post-procedural aspects of performing gastric peroral endoscopic myotomy for the treatment of refractory gastroparesis.

This CPU was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Gastroenterology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors who are advanced endoscopists with expertise in treating patients by performing third-space endoscopy and gastric peroral endoscopic myotomy.

Gastroparesis is characterized by symptoms suggesting gastric retention of food and objective evidence of delayed gastric emptying in the absence of a mechanical obstruction. Nausea, vomiting, early satiety, and postprandial fullness are the classic symptoms of gastroparesis. Gastroparesis is increasingly encountered by physicians. There are several recognized etiologies of gastroparesis, including diabetic, post-surgical, medication-induced, post-viral, and idiopathic.

A comprehensive literature review was conducted to identify studies discussing gastroparesis management. Dietary modifications, medication adjustments, glucose control, antiemetic agents, and prokinetic agents are all part of gastroparesis management. In this manuscript, we detail treatments evolving for gastroparesis, including nutritional, pharmaceutical, device, and recent advanced endoscopic and surgical therapies. This manuscript concludes with a speculative viewpoint on how the field will evolve in 5 years' time.

Identification of the dominant symptoms (fullness, nausea, abdominal pain, and heartburn) helps to direct management efforts of the patients. Treatments for refractory (treatment resistant) symptoms may include gastric electric stimulation and intra-pyloric interventions like botulinum toxin and endoscopic pyloromyotomy. Understanding the pathophysiology of gastroparesis, relating pathophysiologic abnormalities to specific symptoms, new efficacious pharmacotherapies, and better understanding of the clinical predictors of response of therapies, are priorities for future research in the field of gastroparesis.

To provide an updated overview on use of electrostimulation in gastrointestinal motility disorders and obesity, with a focus on gastric electrical stimulation, vagal nerve stimulation and sacral nerve stimulation.

Recent studies on gastric electrical stimulation for chronic vomiting showed a decrease in frequency of vomiting, but without significant improvement in quality of life. Percutaneous vagal nerve stimulation shows some promise for both symptoms of gastroparesis and IBS. Sacral nerve stimulation does not appear effective for constipation. Studies of electroceuticals for treatment of obesity have quite varied results with less clinical penetrance of the technology. Results of studies on the efficacy of electroceuticals have been variable depending on pathology but this area remains promising. Improved mechanistic understanding, technology and more controlled trials will be helpful to establish a clearer role for electrostimulation in treatment of various GI disorders.

Management of refractory gastroparesis is challenging after diet, prokinetics, and long-term nutritional support have failed. In this review, the efficacy and safety of surgical interventions (sleeve gastrectomy and Roux-en-Y gastric bypass surgery) are evaluated systematically in patients with refractory gastroparesis. The PubMed, Embase, and Scopus databases were searched to identify relevant studies published up to June 2021. Outcome of interest was symptom improvement and gastric emptying. Nineteen studies with 222 refractory gastroparesis patients (147 Roux-en-Y gastric bypass, 39 sleeve gastrectomy, and 36 subtotal gastrectomy) were included. All studies reported symptom improvement postoperatively, particularly vomiting and nausea. Gastric emptying improved postoperatively in 45% up to 67% for sleeve gastrectomy and 87% for Roux-en-Y gastric bypass. The findings of our systematic review suggest that sleeve gastrectomy and Roux-en-Y gastric bypass surgery improve symptoms and gastric emptying in patients with refractory gastroparesis. Surgery may be effective as treatment for a small group of patients when all other therapies have failed.

Electroceuticals provide clinical solutions for a range of disorders including Parkinson's disease, cardiac arrythmias and are emerging as a potential treatment option for gastrointestinal disorders. However, pre-clinical investigations are challenged by the large stimulation artifacts registered in bio-electrical recordings.

A generalized framework capable of isolating and suppressing stimulation artifacts with minimal intervention was developed. Stimulation artifacts with different pulse-parameters in synthetic and experimental cardiac and gastrointestinal signals were detected using a Hampel filter and reconstructed using 3 methods: i) autoregression, ii) weighted mean, and iii) linear interpolation.

Synthetic stimulation artifacts with amplitudes of 2 mV and 4 mV and pulse-widths of 50 ms, 100 ms, and 200 ms were successfully isolated and the artifact window size remained uninfluenced by the pulse-amplitude, but was influenced by pulse-width (e.g., the autoregression method resulted in an identical Root Mean Square Error (RMSE) of 1.64 mV for artifacts with 200 ms pulse-width and both 2 mV and 4 mV amplitudes). The performance of autoregression (RMSE = 1.45 ± 0.16 mV) and linear interpolation (RMSE = 1.22 ± 0.14 mV) methods were comparable and better than weighted mean (RMSE = 5.54 ± 0.56 mV) for synthetic data. However, for experimental recordings, artifact removal by autoregression was superior to both linear interpolation and weighted mean approaches in gastric, small intestinal and cardiac recordings.

A novel signal processing framework enabled efficient analysis of bio-electrical recordings with stimulation artifacts. This will allow the bio-electrical events induced by stimulation protocols to be efficiently and systematically evaluated, resulting in improved stimulation therapies.

The pylorus plays a key role in the control of gastric content outflow. Impairment of pyloric physiology has been observed in gastroparesis, particularly when associated with diabetes mellitus or opioid intake or after antireflux surgery. New tools have been developed to identify pyloric dysfunction in routine care, including functional luminal impedance planimetry (FLIP). As such, a new therapeutic strategy targeting the pylorus, namely endoscopic pyloromyotomy (G-POEM), has received increasing attention and emerged as a promising treatment for gastroparesis.

The present review details the involvement of the pyloric pathophysiology in gastroparesis, as well as clinical results of G-POEM according to the current literature.

The efficacy of conventional treatments for severe and chronic functional motility disorders remains limited. High-energy pacing is a promising alternative therapy for patients that fail conventional treatment. Pacing primarily regulates gut motility by modulating rhythmic bio-electrical events called slow waves. While the efficacy of this technique has been widely investigated on the stomach, its application in the small intestine is less developed. This systematic review was undertaken to summarize the status of small intestinal pacing and evaluate its efficacy in modulating bowel function through preclinical research studies.

The literature was searched using Scopus, PubMed, Ovid, Cochrane, CINAHL, and Google Scholar. Studies investigating electrophysiological, motility, and/or nutrient absorption responses to pacing were included. A critical review of all included studies was conducted comparing study outcomes against experimental protocols.

The inclusion criteria were met by 34 publications. A range of pacing parameters including amplitude, pulse width, pacing direction, and its application to broad regional small intestinal segments were identified and assessed. Out of the 34 studies surveyed, 20/23 studies successfully achieved slow-wave entrainment, 9/11 studies enhanced nutrient absorption and 21/27 studies modulated motility with pacing.

Small intestine pacing shows therapeutic potential in treating disorders such as short bowel syndrome and obesity. This systematic review proposes standardized protocols to maximize research outcomes and thereby translate to human studies for clinical validation. The use of novel techniques such as high-resolution electrical, manometric, and optical mapping in future studies will enable a mechanistic understanding of pacing.

Gastroparesis is defined by delayed gastric emptying in the absence of mechanical obstruction of the stomach. Patients experience symptoms of nausea, vomiting, abdominal pain, fullness, and early satiety. The recognition of the disorder has progressed due to availability of gastric emptying scintigraphy and advancements made in understanding its pathophysiology and treatment options. The clinical presentation and treatment of gastroparesis overlap with a more commonly recognized disorder of gut-brain interaction, functional dyspepsia. Recent studies have reenergized the discussion whether these two are separate entities or perhaps reflect a spectrum of gastroduodenal neuromuscular disorders. The societal guidelines conflict on the utility of gastric emptying scintigraphy in assessment of patients with upper gastrointestinal symptoms. A better appraisal of similarities and differences between gastroparesis and functional dyspepsia will allow targeted treatment for these disorders. This is particularly important as specific pharmacological and endoscopic treatment options are being developed for gastroparesis which are unlikely to be helpful for functional dyspepsia. This review makes the case for considering these disorders in a spectrum where identification of both would most ideally position us toward providing the optimal clinical care.

Chronic nausea is a widespread functional disease in children with numerous comorbidities. High-resolution electrogastrogram (HR-EGG) has shown sufficient sensitivity as a noninvasive clinical marker to objectively detect distinct gastric slow wave properties in children with functional nausea. We hypothesized that the increased precision of magnetogastrogram (MGG) slow wave recordings could provide supplementary information not evident on HR-EGG. We evaluated simultaneous pre- and postprandial MGG and HR-EGG recordings in pediatric patients with chronic nausea and healthy asymptomatic subjects, while also measuring nausea intensity and nausea severity. We found significant reductions in postprandial dominant frequency and normogastric power, and higher levels of postprandial bradygastric power in patients with nausea in both MGG and HR-EGG. MGG also detected significantly lower preprandial normogastric power in patients. A significant difference in the mean preprandial gastric slow wave propagation direction was observed in patients as compared with controls in both MGG (control: 180 ± 61°, patient: 34 ±72°; P < 0.05) and HR-EGG (control: 240 ± 39°, patient: 180 ± 46°; P < 0.05). Patients also showed a significant change in the mean slow wave direction between pre- and postprandial periods in MGG (P < 0.05). No statistical differences were observed in propagation speed between healthy subjects and patients in either MGG or HR-EGG pre/postprandial periods. The use of MGG and/or HR-EGG represents an opportunity to assess noninvasively the effects of chronic nausea on gastric slow wave activity. MGG data may offer the opportunity for further refinement of the more portable and economical HR-EGG in future machine-learning approaches for functional nausea.NEW & NOTEWORTHY Pediatric chronic nausea is a difficult-to-measure subjective complaint that requires objective diagnosis, clinical assessment, and individualized treatment plans. Our study demonstrates that multichannel MGG used in conjunction with custom HR-EGG detects key pathological signatures of functional nausea in children. This quantifiable measure may allow more personalized diagnosis and treatment in addition to minimizing the cost and potential radiation associated with current diagnostic approaches.

Gastric emptying is a major determinant of postprandial blood glucose, accounting for ~35% of variance in peak glucose in both healthy individuals and those with type 2 diabetes. Gastric emptying is frequently disordered in individuals with diabetes (both abnormally delayed and accelerated). Delayed gastric emptying, i.e. diabetic gastroparesis, may be linked to upper gastrointestinal symptoms for which current treatment remains suboptimal; pharmacological acceleration of delayed emptying is only weakly associated with symptom improvement. Accordingly, the relationship between symptoms and delayed gastric emptying is not simply 'cause and effect'. In insulin-treated patients, disordered gastric emptying, even when not associated with gastrointestinal symptoms, can cause a mismatch between the onset of insulin action and the availability of absorbed carbohydrate, leading to suboptimal glycaemic control. In patients with type 2 diabetes, interventions that slow gastric emptying, e.g. glucagon-like peptide-1 receptor agonists, reduce postprandial blood glucose. This review focuses on recent insights into the impact of gastric emptying on postprandial blood glucose, effects of diabetes therapy on gastric emptying and the management of disordered gastric emptying in diabetes. In view of the broad relevance of gastric emptying to diabetes management, it is important that future clinical trials evaluating novel therapies that may affect gastric emptying should quantify the latter with an appropriate technique, such as scintigraphy or a stable isotope breath test.

There has been interest in the use of pyloric therapies for the treatment of refractory gastroparesis. However, data on endoscopic pyloric dilation are scarce. We aimed to assess the efficacy and safety of this procedure in refractory gastroparesis.

We performed a retrospective analysis of 47 patients referred for refractory gastroparesis, confirmed by gastric emptying scintigraphy, and treated with endoscopic pyloric through-the-scope balloon dilation. The primary endpoint was the effectiveness of the procedure, evaluated with the Gastric Cardinal Symptom Index (GCSI) at 2 and 6 months.

A clinical response, defined by a 1.0 point decrease in the GCSI score, was observed in 25 patients at 2 months (53%) and in 19 patients at 6 months (40%). The mean GCSI score decreased significantly at 2 and 6 months compared to the preoperative score (3.9 ± 0.87 vs 2.3 ± 1.37 and 3.9 ± 0.87 vs 2.9 ± 1.27, respectively; p < 0.0001). No complication was observed. Nine patients had a delayed relapse at 1 year. A second dilation was performed for eight patients and it was effective in five of them (63%). The mean follow-up time of the patients was 27.0 ± 10.4 months. At 2 years, 15 patients still experienced improvement following this treatment (32%). No predictive factor of clinical response was identified.

The efficacy of pyloric dilation is 53% at 2 months, with sustained improvement in one third of patients at 2 years. This treatment should be considered as an alternative option to pyloromyotomy.

Type 2 and type 1 diabetes are common endocrine disorders with a progressively increasing incidence worldwide. These chronic, systemic diseases have multiorgan implications, and the whole gastrointestinal (GI) tract represents a frequent target in terms of symptom appearance and interdependent pathophysiological mechanisms. Metabolic alterations linked with diabetic complications, neuropathy and disrupted hormone homeostasis can lead to upper and/or lower GI symptoms in up to 75% of diabetic patients, with multifactorial involvement of the oesophagus, stomach, upper and lower intestine, and of the gallbladder. On the other hand, altered gastrointestinal motility and/or secretions are able to affect glucose and lipid homeostasis in the short and long term. Finally, diabetes has been linked with increased cancer risk at different levels of the GI tract. The presence of GI symptoms and a comprehensive assessment of GI function should be carefully considered in the management of diabetic patients to avoid further complications and to ameliorate the quality of life. Additionally, the presence of gastrointestinal dysfunction should be adequately managed to improve metabolic homeostasis, the efficacy of antidiabetic treatments and secondary prevention strategies.

Endoscopic pyloromyotomy (G-POEM) is a minimally invasive treatment option with promising uncontrolled outcome results in patients with gastroparesis.

In this prospective randomised trial, we compared G-POEM with a sham procedure in patients with severe gastroparesis. The primary outcome was the proportion of patients with treatment success (defined as a decrease in the Gastroparesis Cardinal Symptom Index (GCSI) by at least 50%) at 6 months. Patients randomised to the sham group with persistent symptoms were offered cross-over G-POEM.

The enrolment was stopped after the interim analysis by the Data and Safety Monitoring Board prior to reaching the planned sample of 86 patients. A total of 41 patients (17 diabetic, 13 postsurgical, 11 idiopathic; 46% male) were randomised (21 G-POEM, 20-sham). Treatment success rate was 71% (95% CI 50 to 86) after G-POEM versus 22% (8-47) after sham (p=0.005). Treatment success in patients with diabetic, postsurgical and idiopathic gastroparesis was 89% (95% CI 56 to 98), 50% (18-82) and 67% (30-90) after G-POEM; the corresponding rates in the sham group were 17% (3-57), 29% (7-67) and 20% (3-67).Median gastric retention at 4 hours decreased from 22% (95% CI 17 to 31) to 12% (5-22) after G-POEM and did not change after sham: 26% (18-39) versus 24% (11-35). Twelve patients crossed over to G-POEM with 9 of them (75%) achieving treatment success.

In severe gastroparesis, G-POEM is superior to a sham procedure for improving both symptoms and gastric emptying 6 months after the procedure. These results are not entirely conclusive in patients with idiopathic and postsurgical aetiologies.

NCT03356067; ClinicalTrials.gov.