Stent placement for biliary drainage in patients with malignant hilar biliary obstruction (MHBO) has been a topic of long-standing debate, and the best approach remains controversial. Therefore, we aimed to evaluate the efficacy, safety, and removability of multi-hole fully covered self-expandable metal stents (MH-FCSEMSs) in a preclinical experiment using swine hilar bile duct obstruction (HBDO) models and to assess the feasibility and safety of stent placement in patients with MHBO.

Three minipigs underwent endoscopic retrograde cholangiopancreatography (ERCP)-guided endobiliary-radio frequency ablation (EB-RFA) to establish Bismuth type II hilar bile duct stenosis models. Four weeks after EB-RFA, 10-mm diameter and 4-cm length MH-FCSEMSs were endoscopically inserted into the left intrahepatic bile duct of the models. Stent patency and migration, as well as adverse events including cholangitis and endoscopic stent removability, were assessed three months after stent placement. Additionally, clinical applications of MH-FCSEMS were performed in two patients with MHBO to determine feasibility, safety, and stent patency.

MH-FCSEMSs were successfully inserted into the left main intrahepatic bile duct and common hepatic duct of the models under ERCP in all three animals without any technical difficulties. Cholangiograms performed 12 weeks after MH-FCSEMS placement showed no stent migration, and all were successfully removed from the animal models. The functional success rate, defined as a decrease in serum total bilirubin level of more than 50% at 12 weeks after stent placement, was 100%. Moreover, MH-FCSEMSs were successfully inserted in two patients with hilar cholangiocarcinoma. The procedures were technically feasible, and no major periprocedural complications were noted.

The preliminary long-term results of both preclinical and clinical pilot studies suggest that endoscopic biliary drainage using MH-FCSEMS may be a safe and effective treatment option for stenting and stent revision in the management of HBDO. Further studies comparing clinical outcomes to those of MH-FCSEMS without multi-hole in malignant hilar biliary obstruction will be needed to verify the clinical benefits.

Endoscopic retrograde cholangiopancreatography(ERCP) with endoscopic metallic biliary endoprosthesis(EMBE) serves as a crucial palliative treatment for advanced malignant biliary obstruction(MBO). While endoscopic nasobiliary drainage(ENBD) effectively reduces post-ERCP cholangitis (PEC) incidence, its impact on PEC in MBO patients is unclear. This study evaluates ENBD's effects on PEC in patients undergoing EMBE and identifies risk factors.

This retrospective cohort study at the First Hospital of Jilin University involved MBO patients who underwent EMBE from September 2011 to September 2022. Propensity score matching (PSM) was applied to minimize selection bias. Primary and secondary outcomes included the incidence and recovery rate/time of PEC, biliary drainage success, and hospitalization duration. Univariate, multivariate, and Lasso regression analyses identified independent risk factors.

In this study of 1,008 patients, 730 were analyzed after PSM(365 each in the EMBE+ENBD and EMBE groups). No significant differences were observed in PEC incidence(10.7% vs 11.2%, p=0.9057) or recovery rates(48.7% vs 31.7%, p=0.1855). However, PEC recovery time was shorter in the EMBE+ENBD group(4.0 days [3.0, 6.0] vs 5.0 days [4.0, 7.5], p=0.0240), as was hospitalization duration(6.0 days [4.0, 8.0] vs 7.0 days [5.0, 10.0], p=0.0146), and a higher success rate of biliary drainage(54.0% vs 43.3%, p=0.0049). Tumor location(HR 1.10, 95% CI 1.00-1.20) and preoperative total bilirubin(HR 2.13, 95% CI 1.66-2.73) were identified as independent risk factors.

In this large-scale PSM study, ENBD did not reduce PEC incidence but expedited recovery and shortened hospital stays. Patients with hilar MBO of Bismuth III-IV or high preoperative bilirubin were more prone to PEC.

Relief of cholestasis in hilar cholangiocarcinoma is commonly undertaken in both curative and palliative treatment plans. There are numerous open questions with regard to the ideal biliary drainage strategy - including what constitutes clinical success (CS). In the existing data, curative patients and patients from the Western world are underrepresented.

We performed a retrospective analysis of patients with complex malignant hilar obstruction (Bismuth-Corlette II and higher) due to cholangiocarcinoma who underwent biliary drainage at a German referral center between 2010 and 2020. We aimed to define CS and complication rates and directly compare outcomes in curative and palliative patients.

56 curative and 72 palliative patients underwent biliary drainage. In patients with curative intent, CS was achieved significantly more often regardless of what definition of CS was applied (e.g., total serum bilirubin (TSB) < 2 mg/dl: 66.1% vs. 27.8%, p = < 0.001, > 75% reduction of TSB: 57.1% vs. 29.2%, p = 0.003). This observation held true only when subgroups with the same Bismuth-Corlette stage were compared. Moreover, palliative patients experienced a significantly greater percentage of adverse events (33.3% vs. 12.5%, p = 0.01). Curative intent treatment and TSB at presentation were predictive factors of CS regardless of what definition of CS was applied. The observed CS rates are comparable to published studies involving curative patients, but inferior to reported CS rates in palliative series mostly from Asia.

Biliary drainage in complex malignant hilar obstruction due to cholangiocarcinoma is more likely to be successful and less likely to cause adverse events in curative patients compared to palliative patients.

While hilar cholangiocarcinoma (HCCA) patients commonly undergo radioactive stent (RS) insertion treatment, the relative benefits of unilateral versus bilateral RS insertion procedures remain to be established. Accordingly, this study was designed to evaluate the relative safety and efficacy of percutaneous bilateral and unilateral RS insertion for patients with HCCA.

In total, 126 HCCA patients who underwent unilateral (n=64) or bilateral (n=62) RS insertion from January 2017 - December 2021 were included in this analysis. Treatment efficacy and long-term outcomes were compared between groups. The primary endpoint was stent patency, and the secondary endpoints included technical success rate, clinical success rate, local control rate, overall survival (OS), and complications.

The respective technical success rates in the unilateral and bilateral groups were 90.6% (58/64) and 93.5% (58/62) (P = 0.782). The clinical success rates were 82.8% and 86.2% in unilateral and bilateral groups, respectively (P = 0.608). Both groups exhibited comparable medial post-intervention bilirubin levels (100 vs. 99 μmol/L; P = 0.501), and restenosis occurred in 12 (20.7%) and 15 (25.9%) patients over the follow-up interval (P = 0.510). The stent reintervention rate was significantly higher in the unilateral group than bilateral group (66.7% vs. 0.0%, P < 0.001). The median stent patency in the unilateral and bilateral groups was 189 and 210 days, respectively (P = 0.796), while the median OS interval was 222 and 229 days, respectively (P = 0.969). Comparable cholangitis (17.2% vs. 22.4%, P = 0.485) and cholecystitis (3.4% vs. 3.4%, P = 1.000) rates were also detected in these two groups.

In summary, HCCA patients exhibit comparable efficacy when undergoing unilateral and bilateral radioactive stenting, suggesting that unilateral RS can be routinely performed owing to the simpler nature of this procedure.

This study aimed to compare the safety and effectiveness of percutaneous endobiliary radiofrequency ablation with stent placement (RFA group) versus stent placement alone (stent group) in patients with type IV hilar cholangiocarcinoma.

This prospective nonrandomized study was conducted between October 2021 and April 2023. The study included 56 participants (33 men and 23 women, median age 73 years) who underwent percutaneous endobiliary RFA with stent placement (n = 25) or stent placement alone (n = 31) for type IV hilar cholangiocarcinoma. The primary end point was stent patency, while the secondary end points were procedure-related adverse events (AE) and overall survival.

The percutaneous endobiliary RFA and/or stent placement were successfully completed in all patients in both groups. The median stent patency rate was higher in the RFA group than the stent group (188 days vs. 155 days, p = 0.048). There were no differences in AEs (grade 1 [5 in RFA group vs. 5 in stent group, p = 0.74] and grade 2 AEs [2 vs. 4, p = 0.68]) and patients' survival (median 222 days vs. 214 days, p = 0.49) between the two groups.

In patients with type IV hilar cholangiocarcinoma, percutaneous endobiliary RFA with stent placement may improve stent patency without increasing the risk of AEs compared to stent placement alone.

Biliary obstruction in gallbladder cancer (GBC) is associated with worse prognosis and needs drainage. In patients with biliary confluence involvement, percutaneous biliary drainage (PBD) is preferred over endoscopic drainage. However, PBD catheters are associated with higher complications compared to endoscopic drainage. PBD with self-expandable metal stents (SEMS) is desirable for palliation. However, the data in patients with unresectable GBC is lacking.

This retrospective study comprised consecutive patients with proven GBC who underwent PBD-SEMS insertion between January 2021 and December 2022. Technical success, post-procedural complications, clinical success, duration of stent patency, and biliary reinterventions were recorded. Clinical follow-up data was analysed at 30 days and 180 days of SEMS insertion and mortality was recorded.

Of the 416 patients with unresectable GBC, who underwent PBD, 28 (median age, 50 years; 16 females) with PBD-SEMS insertion were included. All SEMS placement procedures were technically successful. There were no immediate/early post-procedural complications/deaths. The procedures were clinically successful in 63.6% of the patients with hyperbilirubinemia (n = 11). Biliary re-interventions were done in 6 (21.4%). The survival rate was 89.3 % (25/28) at 30 days and 50% at 180 days. The median follow-up duration was 80 days (range, 8-438 days).

PBD-SEMS has moderate clinical success and 6-months patency in almost half of the patients with metastatic GBC and must be considered for palliation.

We report a case of ruptured cystic artery pseudoaneurysm after self-expandable metal stent placement for malignant biliary obstruction. A 78-year-old woman on palliative care after chemotherapy for unresectable pancreatic head cancer presented with obstructive jaundice. Imaging revealed a dilated common bile duct and an enlarged gallbladder with cystic wall thickening. Endoscopic retrograde cholangiopancreatography was performed and a fully-covered self-expandable metal stent was placed in the bile duct, leading to resolution of jaundice. She presented with hematochezia 7 days later. Contrast-enhanced computed tomography revealed a cystic artery pseudoaneurysm with extravasation of contrast into a blood-filled gallbladder. Hemostasis was achieved after emergent transcatheter arterial embolization. Rupture of cystic artery pseudoaneurysm should be raised as a differential diagnosis for hemobilia after self-expandable metal stent placement, particularly in cases accompanied by inflamed gallbladders.

Primary biliary tract tumors are malignancies that originate in the liver, bile ducts, or gallbladder. These tumors often present with jaundice of unknown etiology, leading to delayed diagnosis and advanced disease. Currently, several palliative treatment options are available for primary biliary tract tumors. They include percutaneous transhepatic biliary drainage (PTBD), biliary stenting, and surgical interventions such as biliary diversion. Systemic therapy is also commonly used for the palliative treatment of primary biliary tract tumors. It involves the administration of chemotherapy drugs, such as gemcitabine and cisplatin, which have shown promising results in improving overall survival in patients with advanced biliary tract tumors. PTBD is another palliative treatment option for patients with unresectable or inoperable malignant biliary obstruction. Biliary stenting can also be used as a palliative treatment option to alleviate symptoms in patients with unresectable or inoperable malignant biliary obstruction. Surgical interventions, such as biliary diversion, have traditionally been used as palliative options for primary biliary tract tumors. However, biliary diversion only provides temporary relief and does not remove the tumor. Primary biliary tract tumors often present in advanced stages, making palliative treatment the primary option for improving the quality of life of patients.

A consensus meeting of national experts from all major national hepatobiliary centres in the country was held on May 26, 2023, at the Pakistan Kidney and Liver Institute & Research Centre (PKLI & RC) after initial consultations with the experts. The Pakistan Society for the Study of Liver Diseases (PSSLD) and PKLI & RC jointly organised this meeting. This effort was based on a comprehensive literature review to establish national practice guidelines for hilar cholangiocarcinoma (hCCA). The consensus was that hCCA is a complex disease and requires a multidisciplinary team approach to best manage these patients. This coordinated effort can minimise delays and give patients a chance for curative treatment and effective palliation. The diagnostic and staging workup includes high-quality computed tomography, magnetic resonance imaging, and magnetic resonance cholangiopancreatography. Brush cytology or biopsy utilizing endoscopic retrograde cholangiopancreatography is a mainstay for diagnosis. However, histopathologic confirmation is not always required before resection. Endoscopic ultrasound with fine needle aspiration of regional lymph nodes and positron emission tomography scan are valuable adjuncts for staging. The only curative treatment is the surgical resection of the biliary tree based on the Bismuth-Corlette classification. Selected patients with unresectable hCCA can be considered for liver transplantation. Adjuvant chemotherapy should be offered to patients with a high risk of recurrence. The use of preoperative biliary drainage and the need for portal vein embolisation should be based on local multidisciplinary discussions. Patients with acute cholangitis can be drained with endoscopic or percutaneous biliary drainage. Palliative chemotherapy with cisplatin and gemcitabine has shown improved survival in patients with irresectable and recurrent hCCA.

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used for managing malignant biliary obstruction; however, it is impossible if the endoscope cannot reach the ampulla of Vater, and it carries a risk of procedure-related pancreatitis. Percutaneous approach is a traditional rescue method when ERCP fails and can be useful in advanced malignant hilar biliary obstruction; however, it is invasive and carries risks of tube dislodgement, recurrent infection, and tract seeding. Endoscopic ultrasound approach may be attempted if ERCP fails and is free from the risk of pancreatitis; however, it is only possible in limited centers, and training is still difficult. Malignant biliary obstruction should be managed by leveraging the complementary strengths of these methods.

Stent implantation is an effective approach for palliative treatment of Bismuth-Corlette type III-IV malignant hilar biliary obstructions (MHBOs). In this article, we reviewed the currently used access methods for biliary stent placement (percutaneous transhepatic biliary drainage, endoscopic biliary drainage, endosonography guided biliary drainage), the available stent types (plastic stent, self-expanding metallic stent, full cover self-expanding metallic stent, radioactive self-expanding metallic stent), major approaches (unilateral, bilateral) and deployment methods (stent-in-stent, stent-by-stent). Finally, this review gives an outlook on perspectives of development in stenting and other palliative methods in MHBO.

Current standard treatment for perihilar cholangiocarcinoma (pCCA) is surgical resection. Bismuth-Corlette (BC) type IV pCCA is accepted as an unresectable disease. In the present study, the results of non-transplant surgical approaches in patients with BC type IV pCCA were examined.

Medical records of consecutive patients with BC type IV pCCA between 2010 and 2021 were retrospectively reviewed. Patients were subdivided according to operation type. Postoperative survival rates were compared.

Hemihepatectomy with caudate lobe and extrahepatic bile duct (EHBD) resection was performed in 15 patients and only EHBD resection was performed in 10 patients. Ten of the cases were found to be unresectable at the stage of laparotomy. Median follow-up was 41.3 (24.8-57.9) months. Overall survival rate for all 35 patients was 56.4% at 1 year, 32.2% at 2 years, and 16.1% at 3 years. When survivals were compared according to operation type, 1, 2, and 3-year survivals were 80%, 57.1% and 42.9% for the hepatectomy group; 55.6%, 44.4% and 11.1% for the EHBD resection group; 75%, 0% and 0% in laparotomy-only group, respectively (p = 0.13). The best survival rates were obtained in patients with pCCA who underwent hepatectomy and were lymph node negative, 100% for 1 year, 66.7 for 2 years and 50% for 3 years.

It is difficult to achieve high survival rates in BC type IV pCCA. However, these patients mostly benefit from resective treatments. Acceptable survival rates can be achieved, especially in the R0N0 patient group.

We report the case of a 65-year-old man who experienced hemobilia due to rupture of a pseudoaneurysm of the left hepatic artery after endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS). The patient was diagnosed with pancreatic cancer and underwent endoscopic retrograde cholangiopancreatography for obstructive jaundice. Biliary drainage was converted to EUS-HGS due to tumor invasion in the superior duodenal angle. A partially covered metal stent was placed in the B3 intrahepatic bile duct. The procedure was completed without early complications, but 50 days later, the patient developed fever, elevated hepatobiliary enzymes, and shock. Contrast-enhanced computed tomography (CT) showed that the hepatic end of the HGS stent had moved slightly toward the stomach compared to the previous CT. A 6-mm pseudoaneurysm was also observed near the A3 and A4 branches of the left hepatic artery, coinciding with the hepatic end of the EUS-HGS stent. Hemostasis was achieved with coil embolization. Biliary hemorrhage due to rupture of a pseudoaneurysm should be considered in the differential diagnosis of biliary obstruction accompanied by bleeding after EUS-HGS.

This study aimed to investigate the risk factors for 30-day mortality in patients with malignant biliary obstruction (MBO) after endoscopic retrograde cholangiopancreatography (ERCP) with endobiliary metal stent placement. Furthermore, we aimed to construct and visualize a prediction model based on LASSO-logistic regression.

Data were collected from 245 patients who underwent their first ERCP with endobiliary metal stent placement for unresectable MBO between June 1, 2013, and August 31, 2021. Univariable and multivariable logistic regression analyses were conducted to identify the risk factors for 30-day mortality. We subsequently developed a logistic regression model that incorporated multiple parameters identified by LASSO regression. The model was visualized and the nomogram was plotted. Risk stratification was performed based on nomogram-derived scores.

The 30-day mortality rate was 10.7% (23/245 patients). Distant metastasis, total bilirubin, post-ERCP complications, and successful drainage were independent risk factors of 30-day mortality. The variables screened by LASSO regression, including distant metastasis, total bilirubin, post-ERCP complications, and successful drainage, were incorporated into the logistic model. The results were visualized through a nomogram based on the model. To assess the model's performance, discrimination was evaluated using the area-under-the-curve values obtained from receiver operating characteristic analyses with 10-fold cross-validation in the training group and validated in the testing group. The calibration curve showed the good predictive ability of the model. Decision curve analysis is used to evaluate the clinical application of nomogram. Finally, we performed risk stratification based on the risk calculated using the nomogram. Patients were assigned to the low-, moderate-, and high-risk groups based on their probability scores. The Kaplan-Meier survival curves for the different nomogram-based groups were significantly different (p < 0.001).

We developed a nomogram using the LASSO-logistic regression model to forecast the 30-day mortality rate in patients who had undergone ERCP with endobiliary metal stent placement due to MBO. This nomogram can assist in identifying individuals at high-risk of 30-day mortality following ERCP.

Malignant biliary obstruction is an ominous complication of metastatic colorectal cancer (mCRC) that is challenging to solve. Biliary drainage can be performed to relieve symptoms of jaundice, treat cholangitis, or enable palliative systemic therapy. The aim of this study is to evaluate clinical outcomes of biliary drainage of malignant biliary obstruction in mCRC patients.

Consecutive patients with malignant biliary obstruction due to mCRC who underwent endoscopic retrograde cholangiopancreatography or percutaneous transhepatic cholangiography were included. Patient, disease, and procedural characteristics and outcomes were retrospectively collected from electronic medical records. Radiological data were prospectively reassessed. Main outcome was functional success, i.e. achievement of the intended goal of biliary drainage. Prognostic factors for functional success and survival were assessed.

Thirty-seven patients were included. Functional success was achieved in 18 (50%) patients. Seventeen (46%) patients experienced adverse events (suspected to be) related to the procedure. Median overall survival after biliary drainage was 61 days (IQR 31-113). No prognostic factors of functional success were identified. Performance status, presence of the primary tumor, ascites, ≥ 5 intrahepatic metastases, estimated hepatic invasion of > 50% and above-median levels of bilirubin and lactate dehydrogenase were significantly associated with poorer survival. Improved survival was seen in patients with technical, functional, or biochemical success, and with subsequent oncologic treatment.

Functional successful biliary drainage was achieved in half of the patients. Adverse events also occurred in nearly half of the patients. We observed a significantly longer survival in whom biliary drainage allowed palliative oncologic therapy.