Dome vs tapered tip sphincterotomes in endoscopic retrograde cholangiopancreatography: A pilot study on cannulation success and postprocedural pancreatitis

Abstract

BACKGROUND

Despite advancements, endoscopic retrograde cholangiopancreatography (ERCP) poses challenges, including the risk of post-ERCP pancreatitis and difficulty of biliary cannulation.

AIM

To compare dome and tapered tip sphincterotomes, focusing on their efficacy in achieving successful biliary cannulation and reducing the incidence of post-ERCP pancreatitis.

METHODS

In this prospective, single-blind, randomized pilot study conducted at Inha University Hospital, 85 patients undergoing ERCP were equally divided into dome and tapered tip sphincterotome groups. The co-primary outcomes were the success rate of selective biliary cannulation and incidence of post-ERCP pancreatitis. The secondary outcomes included biliary cannulation time, number of unintended pancreatic duct access events, and total procedure time.

RESULTS

The success rates of selective biliary cannulation were 74.4% and 85.7% in the dome and tapered tip groups, respectively, with no significant difference (P = 0.20). Similarly, the incidence of post-ERCP pancreatitis did not differ significantly between the groups (5 cases in the tapered tip group vs 6 in the dome tip group, P = 0.72). However, difficult cannulation was significantly more common in the dome tip group than in the tapered tip group (P = 0.05). Selective biliary cannulation time emerged as a significant predictor of post-ERCP pancreatitis (multivariate odds ratio = 9.33, 95% confidence interval: 1.31-66.44, P = 0.03).

CONCLUSION

This study indicated that the sphincterotome tip type does not markedly affect biliary cannulation success or post-ERCP pancreatitis rates. However, cannulation duration is a key risk factor for post-ERCP pancreatitis. These findings provide preliminary insights that highlight the importance of refining ERCP practices, including sphincterotome selection, while underscoring the need for larger multicenter studies to improve procedure time and patient safety.

Key Words: Endoscopic retrograde cholangiopancreatography; Post-endoscopic retrograde cholangiopancreatography pancreatitis; Selective biliary cannulation; Sphincterotome tip configuration; Pancreatitis

Core Tip: This pilot study compared dome and tapered tip sphincterotomes in endoscopic retrograde cholangiopancreatography (ERCP), with focus on selective biliary cannulation success and post-ERCP pancreatitis. Although cannulation success and pancreatitis rates did not differ significantly between the two tip types, a prolonged cannulation time was a key predictor of post-ERCP pancreatitis. The tapered tip group encountered fewer cannulation difficulties, suggesting a maneuverability advantage. These findings underscore the importance of minimizing cannulation time and support the need for larger multicenter studies to refine ERCP practices and improve patient safety.

INTRODUCTION

Since the initial introduction of endoscopic cholangiography and the subsequent development of the first endoscopic sphincterotomy over five decades ago, the practice of endoscopic retrograde cholangiopancreatography (ERCP) alongside biliary sphincterotomy was accepted as a safe, direct technique for evaluating pancreaticobiliary diseases[1,2]. It has been recognized as a standard diagnostic and therapeutic intervention for biliary diseases. Over time, the scope of ERCP and its therapeutic impact have broadened substantially, now encompassing a wide spectrum of pathologies within the pancreatic and biliary tracts[3,4].

Precise cannulation of the common bile duct via the ampulla of Vater is essential for a successful ERCP. Nonetheless, this procedure is frequently challenged by two main issues: Failure to accomplish biliary cannulation and occurrence of post-ERCP pancreatitis. Regrettably, even for highly skilled specialists, the success rate of conventional bile duct cannulation techniques is less than ideal, with failure rates between 11.2% and 16%[5-7]. This necessitates prolonged attempts at cannulation, which not only increases the likelihood of pancreatitis from chemical and mechanical damage to the pancreatic duct but also results in the deferral of essential treatment. Thus, to avoid pancreatitis caused by cannulation issues, techniques that improve the accuracy of biliary cannulation can help reduce the risk of pancreatitis. This is achieved by causing less damage to the papilla and decreasing accidental entry into the pancreatic duct.

The tools used for cannulation are categorically divided into cannulation catheters, sphincterotomes (also known as papillotomes), and access (precut) papillotomy catheters[8]. Despite the array of available devices, an optimal approach for safe and effective cannulation is yet to be definitively established[9-11]. Within this spectrum of techniques, sphincterotome-assisted cannulation is frequently recognized as an effective strategy for securing biliary access[8,12]. Sphincterotomes, typically tapered and occasionally dome-shaped, ranging from 3.5 to 5.5 Fr, facilitate duct system access[13]. The dome tip sphincterotome, designed with a smooth hemispherical end similar to that of an egg, ensures gentle cannulation with minimal tissue damage[14]. Despite the widespread use of sphincterotomes, there is a notable lack of prospective studies exploring the impact of the device tip shape on cannulation success rates or the incidence of post-ERCP pancreatitis. This pilot study aimed to evaluate the comparative effectiveness of dome- and tapered tip sphincterotomes in achieving successful selective biliary cannulation and reducing the incidence of post-ERCP pancreatitis.

MATERIALS AND METHODS

Study design

This prospective, single-blind, randomized, single-center pilot study was conducted to assess and compare the efficacy and safety of dome and tapered tip sphincterotomes in patients undergoing ERCP. The patients were recruited between February 2023 and February 2024. Eighty-five patients that underwent diagnostic or therapeutic biliary ERCP were equally randomized to a dome tip or tapered tip sphincterotome arm. A schematic of the study design is shown in Figure 1.

Figure 1 Schematic of the study protocol. ERCP: Endoscopic retrograde cholangiopancreatography.

Patients

All patients were recruited from Inha University Hospital (a Korean tertiary referral hospital). During the study period, all eligible patients who met the inclusion criteria were consecutively enrolled. The eligibility criteria were as follows: (1) Age > 18 years; (2) Scheduled for a diagnostic or therapeutic biliary ERCP; and (3) Provision of voluntary informed consent. Patients were excluded if they met any of the following criteria: (1) History of ERCP-related procedures; (2) Scheduled for a diagnostic or therapeutic pancreatic ERCP; (3) Acute pancreatitis; (4) History of abdominal surgery and Billroth II or Roux-en-Y reconstruction; (5) Pregnancy; (6) Coagulopathy; or (7) Serious cardiopulmonary disease. Participants were assigned to either the dome or tapered tip group through a randomization process, utilizing a predetermined number of sequences established before the study began.

ERCP and cannulation procedure with dome or tapered tip sphincterotome

In this study, each ERCP was conducted by an expert endoscopist with at least a decade of experience and who performed up to 500 ERCPs annually. The procedures were performed using a TJF-Q290V side-viewing duodenoscope (Olympus Medical Systems, Tokyo, Japan). The initiation involved navigating the duodenoscope to the second part of the duodenum, with patients sedated using 5 mg intravenous remimazolam, ensuring optimal comfort and safety under conscious sedation. Upon securing the duodenoscope in an optimal position for visualizing the papilla of Vater, cannulation was performed using either a dome (Tri-Tome^® Protector^™, Cook Medical, Winston-Salem, NC, United States) or tapered tip (PAP1-F8-25-35-OL, FUJIFILM medwork GmbH, Höchstadt, Germany) sphincterotome, based on the randomized assignment (Figure 2). Precise minimal insertion of the sphincterotome (1-3 mm) facilitated the advancement of a 0.035-inch VisiGlide 2 guidewire (Olympus Medical Systems) under fluoroscopic guidance to ensure correct bile duct entry. In cases where the guidewire inadvertently entered the pancreatic duct, it was swiftly withdrawn and another attempt at correct biliary cannulation was made. Failure to achieve bile duct cannulation within the first 5 minutes necessitated alternative approaches, such as switching the sphincterotome to the opposite arm, performing a precut sphincterotomy, or using the pancreatic duct guidewire technique to achieve selective biliary cannulation determined at the discretion of the endoscopist.

Figure 2 Images of sphincterotomes. A: Dome tip sphincterotome (Tri-Tome^® Protector^™, Cook Medical); B: Tapered tip sphincterotome (PAP1-F8-25-35-OL, FUJIFILM medwork GmbH).

Outcome measurements and definitions

The primary outcomes were the technical success rate of selective biliary cannulation and occurrence of post-ERCP pancreatitis. The secondary outcomes included the rate of difficult biliary cannulation, duration of biliary cannulation, frequency of unintended pancreatic duct access, and number of attempts made to cannulate the papilla. Difficult biliary cannulation is indicated by any of the following situations: The cannulation attempt continues for over 5 minutes; there are more than five contacts made with the papilla, or there is more than one unintended cannulation or opacification of the pancreatic duct[15]. Unintended pancreatic access was defined as the total number of instances of contrast medium injection or guidewire entry into the pancreatic duct. Successful biliary cannulation was characterized by the ability to navigate and instrument the biliary tree freely and deeply within a 5-minute timeframe. The time to selective biliary cannulation was defined as the time required for biliary cannulation, calculated from the moment the sphincterotome or guidewire initially contacted the papilla of Vater to the point of successful cannulation. The total procedure time was defined as the duration from side-viewing duodenoscope insertion into the patient to duodenoscope removal. When access to the bile duct was not achieved within 5 minutes using either a dome or tapered tip sphincterotome, rescue cannulation techniques such as precut and pancreatic duct guidewire placement were employed. The diagnosis of post-ERCP pancreatitis was based on the criteria established by Cotton et al[16].

Statistical analysis

The clinical characteristics of the study participants are expressed as means ± SDs for continuous variables and n (%) for categorical variables. The significance of the differences between the dome and tapered tip groups was determined using the Student’s t-test for continuous variables or the χ² test for categorical variables. Statistical analysis was used to compare the co-primary endpoints between the two groups, and univariate and multivariate analyses were conducted to identify potential risk factors for post-ERCP pancreatitis. The analysis was performed using SPSS v19.0 (SPSS Inc., Chicago, IL, United States), and P values < 0.05 were considered statistically significant.

Ethics statement

The study protocol was approved by the Institutional Review Board of Inha University Hospital (INHAUH 2022-10-008), and written informed consent was obtained from all participants before the commencement of the study. This study was conducted in accordance with the guidelines of the Declaration of Helsinki and Good Clinical Practice.

RESULTS

Baseline characteristics

Of the 90 patients screened for ERCP, 45 were initially allocated to the dome tip group and 45 to the tapered tip group. Following randomization, the groups were revised based on the exclusion criteria and participant withdrawal, resulting in 43 patients in the dome tip group and 42 in the tapered tip group (Table 1). The median age in the dome tip group was 72 years (range 32-91), whereas that in the tapered tip group was 71 years (range 32-92), with no significant difference (P = 0.59). The sex composition was comparable, with 15 males and 30 females in the dome tip group and 19 males and 26 females in the tapered tip group, which was not significantly different (P = 0.12). Body mass index was similar between the groups, with the dome tip group averaging 24.06 ± 4.79 and the tapered tip group averaging 24.81 ± 4.03 (P = 0.81). Regarding the indications for ERCP, 11 patients in the dome tip group and 7 in the tapered tip group presented with malignant conditions, including pancreatic cancer, cholangiocarcinoma, and other cancers. Benign conditions, including choledocholithiasis and benign biliary strictures, were observed in 34 patients in the dome tip group and in 38 patients in the tapered tip group. There was no significant difference in the distribution of malignant and benign conditions between the groups (P = 0.4) (Table 1).

Table 1 Baseline demographic and clinical characteristics of the study population, n (%).

Variables	Dome tip (n = 45)	Tapered tip (n = 45)	P value1
Age, year (median, min-max)	72 (32-91)	71 (32-92)	0.59
Age ≥ 65	30 (66.7)	26 (57.8)
Age < 65	15 (33.3)	19 (42.2)
Sex			0.12
Male	15 (33.3)	19 (42.2)
Female	30 (66.7)	26 (57.8)
BMI	24.06 ± 4.79	24.81 ± 4.03	0.81
BMI ≥ 25 kg/m2	12 (26.7)	21 (46.7)
BMI < 25 kg/m2	33 (73.3)	24 (53.3)
Indications (malignant/benign)			0.4
Malignant
Pancreatic cancer	3 (6.7)	2 (4.4)
Cholangiocarcinoma	5 (11.1)	5 (11.1)
Other cancers	3 (6.7)	0 (0.0)
Benign
Choledocholithiasis	32 (71.1)	34 (75.6)
Benign biliary stricture	2 (4.4)	4 (8.9)

¹P values were calculated using the t-test for continuous variables and χ² test for categorical variables.

BMI: Body mass index.

Cannulation outcomes

In this study, ERCP patients were allocated to either the dome tip or tapered tip sphincterotome group to evaluate the success of selective biliary cannulation. The success rates of the 85 participants were 74.4% in the dome tip group and 85.7% in the tapered tip group, a difference that was not statistically significant (P = 0.20). However, the tapered tip group experienced significantly fewer difficult cannulations, defined by over five contacts with the papilla or attempts lasting longer than 5 minutes, with a rate of 14.3% compared with 32.6% in the dome tip group (P = 0.05). The mean times to achieve cannulation were comparable between the groups (P = 0.43), with the dome tip at 237.74 ± 252.36 seconds and the tapered tip at 188.7 ± 319.96 seconds. The number of papilla contacts showed no significant difference either, with 3.03 ± 2.45 contacts for the dome tip and 2.24 ± 2.17 for the tapered tip (P = 0.37). Similarly, unintentional pancreatic duct cannulation was infrequent and statistically similar in both the groups (P = 0.53). The total procedure time was somewhat shorter for the tapered tip group, at 808 ± 409.57 seconds vs 971.16 ± 367.13 seconds for the dome tip group, which approached but did not achieve statistical significance (P = 0.06) (Table 2). In cases where bile duct access was not achieved within 5 minutes, 7 out of 11 patients in the dome tip arm resorted to using a tapered tip sphincterotome, whereas in the tapered tip arm, 2 out of 6 patients switched to a dome tip. The choice of sphincterotome for rescue cannulation did not differ significantly between the groups (P = 0.34). For the pancreatic duct guidewire technique and precut sphincterotomy, preferences for rescue methods were similarly non-significant between the groups (P = 0.60 and P = 0.59, respectively) (Table 3).

Table 2 Outcomes of cannulation and procedural metrics.

Variables	Dome tip (n = 43)	Tapered tip (n = 42)	P value1
Selective biliary cannulation success rate	32/43	36/42	0.20
Difficult cannulation	14/43	6/42	0.05
More than 5 contacts with the papilla	5	2	0.93
More than 5 minutes spent attempting	11	6	0.08
More than one unintended pancreatic duct cannulation or opacification	3	2	0.62
Time to selective biliary cannulation (seconds)	237.74 ± 252.36	188.7 ± 319.96	0.43
Number of papilla contacts	3.03 ± 2.45	2.24 ± 2.17	0.37
Number of unintentional P duct cannulation	0.47 ± 0.63	0.38 ± 0.58	0.53
Total procedure time (seconds)	971.16 ± 367.13	808 ± 409.57	0.06

¹P values were calculated using the t-test for continuous variables and χ² test for categorical variables.

Table 3 Rescue cannulation techniques.

Variables	Dome tip	Tapered tip	P value1
Switching the sphincterotome to either a dome tip or a tapered tip	7	2	0.34
Pancreatic duct guidewire technique	3	3	0.60
Precut sphincterotomy	1	1	0.59
Total	11	6

¹P values were calculated using the t-test for continuous variables and χ² test for categorical variables.

Safety

In the assessment of post-ERCP complications, the rate of pancreatitis following the procedure was recorded in both the tapered and dome tip groups. The tapered tip group exhibited post-ERCP pancreatitis in five cases, whereas the dome tip group reported six cases. However, this difference was not statistically significant (P = 0.72), indicating that the shape of the sphincterotome tip did not have a measurable impact on the incidence of post-ERCP pancreatitis. Additionally, neither group reported instances of post-ERCP bleeding or perforation, suggesting a consistent safety profile for these specific complications between the two techniques (Table 4). All 11 patients who developed post-ERCP pancreatitis were diagnosed with mild acute pancreatitis according to the Atlanta Classification System[17]. These patients showed improvement after 1-3 days of intravenous hydration.

Table 4 Incidence of post-endoscopic retrograde cholangiopancreatography complications, n (%).

Variables	Dome tip (n = 43)	Tapered tip (n = 42)	P value1
Rate of post-ERCP pancreatitis	6 (14.0)	5 (11.9)	0.72
Rate of post-ERCP bleeding	0 (0.0)	0 (0.0)	-
Rate of perforation	0 (0.0)	0 (0.0)	-

¹P values were calculated using the t-test for continuous variables and χ² test for categorical variables.

ERCP: Endoscopic retrograde cholangiopancreatography.

Identifying predictive factors for post-ERCP pancreatitis: Insights from univariate and multivariate analyses

In the exploration of factors predictive of post-ERCP pancreatitis through both univariate and multivariate analyses, we found that demographics such as age, sex, body mass index, nature of the condition (whether malignant or benign), type of sphincterotome used (dome vs tapered) and the use of rescue cannulation techniques were not significantly associated with the developing pancreatitis after ERCP. Notably, the time spent on selective biliary cannulation was identified as a crucial predictor of an increased risk of pancreatitis, with marked significance observed in the univariate analysis (odds ratio = 14.00, P < 0.001), and significance was maintained after adjustment in the multivariate model (odds ratio = 9.33, P = 0.03). Although the overall duration of the ERCP procedure was initially found to be significant, its impact diminished in the multivariate analysis. The number of attempts to contact the papilla with contrast was shown to have a protective effect in the univariate model; however, this significance was not maintained in further analysis. Lastly, the incidence of unintentional pancreatic duct cannulation was not significantly associated with the development of post-ERCP pancreatitis (Table 5).

Table 5 Analysis of predictive factors for post-endoscopic retrograde cholangiopancreatography pancreatitis: A univariate and multivariate analysis.

Variables	Univariate			Multivariate
	Odds ratio	95%CI	P value1	Odds ratio	95%CI	P value1
Age	0.48	0.13-1.72	0.26
Sex	1.75	0.47-6.49	0.40
BMI	2.09	0.58-7.50	0.26
Malignant/benign	0.95	0.18-4.90	0.95
Dome tip vs tapered tip	1.27	0.36-4.52	0.72
Time to selective biliary cannulation	14.00	2.77-70.86	0.00	9.33	1.31-66.44	0.03
Time to ERCP procedure	6.98	1.41-34.64	0.02	3.23	0.50-20.80	0.22
Number of contrast papilla contact	0.18	0.04-0.74	0.02	1.00	0.14-6.94	1.00
Number of unintentional P duct cannulation	0.43	0.12-1053	0.19
Rescue cannulation	2.68	0.68-10.52	0.16

¹P values were calculated using the t-test for continuous variables and χ² test for categorical variables.

CI: Confidence interval; BMI: Body mass index; ERCP: Endoscopic retrograde cholangiopancreatography.

DISCUSSION

Our study assessed the impact of sphincterotome tip type on ERCP outcomes by specifically examining the relative efficacy of dome and tapered tip devices in routine practice. Our comparative analysis revealed no significant difference in the success rate of selective biliary cannulation or in the incidence of post-ERCP pancreatitis between the two sphincterotome types. Although the success rate of biliary cannulation was higher in the tapered tip group (85.7%) than in the dome tip group (74.4%), the difference was not statistically significant (P = 0.20). The lack of statistical significance could be attributed to the relatively small sample size (n = 85) of the study. Furthermore, one of the study’s primary endpoints, incidence of post-ERCP pancreatitis, showed no significant variation between the groups, with the tapered tip group experiencing 5 cases and the dome tip group experiencing 6 cases (P = 0.72). However, interestingly, in the analysis of ERCP outcomes, the incidence of difficult cannulation was significantly higher in the group using dome tip sphincterotomes (P = 0.05). This suggests that the slender end of the tapered tip may facilitate finer manipulation, improving ease of cannulation. In addition, the time required to achieve selective biliary cannulation was identified as a critical factor influencing the risk of post-ERCP pancreatitis. The data revealed that prolonged duration of the cannulation process significantly increased the likelihood of developing pancreatitis, with a multivariate odds ratio of 9.33 [95% confidence interval (CI): 1.31-66.44, P = 0.03]. Our findings emphasize the critical role of minimizing biliary cannulation time as a strategy to mitigate the risk of post-ERCP pancreatitis.

All ERCP procedures commence with the selective cannulation of the bile or pancreatic duct, which is a pivotal step that significantly influences the success of the procedure. Successful ERCP requires deep cannulation of the common bile duct through the papilla of Vater. Cannulating the major papilla can pose challenges, with reports indicating that selective biliary cannulation fails in up to 18% of attempts, though experienced practitioners can reduce this failure rate to less than or equal to 5%[18,19]. To improve the rates of successful selective cannulation, various sphincterotome tips, including straight, tapered, ultra-tapered, dome, swing, and ball tips, have been developed[20]. Although each design offers distinct advantages, no single configuration has emerged as definitively superior. Consequently, device selection in clinical practice frequently hinges on the endoscopist’s preference, and direct comparative analyses focusing on sphincterotome tip shape remain limited. Our study found that the incidence of difficult cannulation was significantly lower in the tapered tip group than in the dome tip group (P < 0.05). This suggests that the slender end of the tapered tip may have facilitated finer manipulation. This characteristic may diminish the efficacy of the dome tip in achieving deep cannulation compared with the tapered tip. The difficulty in performing biliary cannulation without deep cannulation is often linked to the clinical preference for curved guidewires over straight guidewires, which may ultimately lower the success rate of biliary cannulation. Furthermore, intricate manipulation of the sphincterotome and guidewire by endoscopists with lower proficiency can accentuate these characteristics, potentially increasing the risk of cannulation failure. However, these preliminary findings underscore the need for further large-scale studies.

Post-ERCP pancreatitis is a substantial adverse event, affecting approximately 8% of patients at average risk and escalating to 15% among those at higher risk, thereby representing a major complication in gastrointestinal endoscopy practice[21,22]. The genesis of this condition is attributed to a complex interplay of mechanical, thermal, and chemical stressors on the pancreatic duct and papilla, initiating an inflammatory cascade that can lead to severe systemic complications, including mortality rate of 1 in 500[21-23]. Innovations such as pancreatic stents, rectal non-steroidal anti-inflammatory drugs, and aggressive hydration strategies have been developed to mitigate such risks; however, their application in clinical practice is often impeded by patient comorbidities, particularly in settings such as Korea, where certain interventions are not feasible. Our analysis identified the duration of selective biliary cannulation as a significant predictor of the development of post-ERCP pancreatitis (P < 0.01), emphasizing the critical need to minimize selective biliary cannulation times as a preventative measure. This insight calls for additional research to define the optimal cannulation duration that could significantly reduce the incidence of post-ERCP pancreatitis. The length of the entire ERCP procedure also emerged as a noteworthy predictor in the univariate analysis (odds ratio = 6.98, 95%CI: 1.41-34.64, P = 0.02), although this association did not hold in the multivariate analysis (odds ratio = 3.23, 95%CI: 0.50-20.80, P = 0.22). Furthermore, the study revealed no discernible difference in post-ERCP pancreatitis incidence between the sphincterotome tip groups. However, a pronounced discrepancy was noted in the frequency of difficult cannulations, with the dome tip group exhibiting a significantly higher rate (P < 0.05), suggesting that sphincterotome tip configuration may play a role in procedural challenges. Therefore, further large-scale studies are required to determine whether sphincterotome configuration influences the incidence rate of post-ERCP pancreatitis.

Our study had several limitations. First, the sample size of approximately 45 participants per group, although sufficient for a pilot study, limited the statistical power of our findings and may not fully reflect the broader patient population, thereby affecting the generalizability of our results. Additionally, the pilot design implied a preliminary exploration rather than conclusive evidence, highlighting the need for confirmatory research. Second, the relatively small number of post-ERCP pancreatitis cases (n = 11) led to wide CIs in our statistical analysis, suggesting potential overfitting. Further investigations with a wider patient base would help refine the role of cannulation time as a predictor of post-ERCP pancreatitis and validate these initial observations. Furthermore, the study did not account for variations in anatomical challenges among patients, such as differences in bile duct anatomy or the presence of pancreaticobiliary diseases, which could affect the ease of cannulation, and consequently, the procedure time. Additionally, our focus on the selective biliary cannulation success rate and incidence of post-ERCP pancreatitis as co-primary outcomes does not encompass other critical factors such as patient-reported outcomes, endoscopist’s subjective assessment, and medical costs. Although the above primary outcomes are essential aspects of successful ERCP procedures, a comprehensive evaluation of sphincterotome performance should consider these additional outcomes to provide a more holistic understanding of the advantages and disadvantages of dome tip vs tapered tip sphincterotomes. Another limitation was that the study was conducted by a single expert practitioner. While this approach ensured consistency in the technique and potentially minimized the variability in procedure times across cases, it also introduced a caveat when generalizing the findings. ERCP cannulation is a technically demanding procedure, and operator skill can significantly affect the outcomes. As the study’s results are based on the practice of a single expert, extrapolating these results to a broader community of practitioners with varying levels of expertise and experience may not be straightforward. Future studies could include multicenter trials with larger, more diverse populations to validate these findings and explore the broader implications of sphincterotome tip design. Additional outcomes, such as cost-effectiveness and patient satisfaction, may also be warranted to elucidate the clinical utility of these devices.

CONCLUSION

In conclusion, this pilot study highlights the minimal impact of sphincterotome tip design on successful biliary cannulation and post-ERCP pancreatitis rates, while identifying biliary cannulation time as a significant predictor of post-ERCP pancreatitis. Despite the lack of significant differences in the occurrence of post-ERCP pancreatitis between the dome and tapered tip groups, the increased difficulty of cannulation observed in the dome tip group indicates the need for a deeper exploration into the practical use of these tools. We recommend that future multicenter studies with larger, more diverse populations be conducted to confirm these preliminary findings and to develop optimized protocols aimed at reducing cannulation times and enhancing patient safety.