Addition of Mechanical Lithotripsy to Endoscopic Papillary Large Balloon Dilation in Patients with Difficult Common Bile Duct Stones: A Retrospective Single-Center Study.

Introduction: This study aimed to compare the treatment outcomes of endoscopic papillary large-balloon dilation (EPLBD) with and without mechanical lithotripsy (ML) in removing difficult common bile duct stones. Methods: Patients with difficult common bile duct stones treated with EPLBD, with or without ML, at the Eastern Chiba Medical Center between April 2014 and March 2020, were retrospectively evaluated. The rates of cumulative recurrence and complications were compared between the two groups. Results: Overall, 122 patients (n = 44, EPLBD + ML and n = 78, EPLBD) treated by 12 gastroenterologists were included. Patients in the EPLBD + ML group were older (85 years versus 81.5 years) and had larger maximum stone diameter (15 mm versus 12.5 mm) than those in the EPLBD group. Compared with the EPLBD group, the EPLBD + ML group required more endoscopic retrograde cholangiopancreatography (ERCP) procedures (≥2) (86% versus 67%) and longer total ERCP time after reaching the papilla (78.5 minutes versus 25 minutes). Complication rates were not significantly different (9.1% versus 12.8%); however, the cumulative recurrence rates were higher in the EPLBD + ML group than in the EPLBD group (69.4% versus 23.5% at 4 years). Conclusion: Although there were no differences in complication rates, the long-term recurrence rate was higher in the EPLBD + ML group than in the EPLBD group. This study emphasizes the added burden imposed by performing ML during ERCP and suggests that by appropriate case selection, it is possible to treat cases of difficult biliary stones using EPLBD without ML.

Long-term outcomes of endoscopic papillary large-balloon dilation (12-15 mm) with or without limited sphincterotomy for removal of bile duct stones.

BACKGROUND: Limited endoscopic sphincterotomy with large balloon dilation (ES-LBD) and endoscopic papillary large-balloon dilation (EPLBD) have been proven safe and effective for removal of bile duct stones. However, the long-term outcomes are not clear. The aim of this study was to assess the long-term outcomes of EPLBD (12-15 mm) with or without limited sphincterotomy for removal of common bile duct (CBD) stones. METHODS: Patients with EPLBD or ES-LBD referred for the removal of bile-duct stones between June 2008 and August 2020 were retrospectively reviewed. Complete stone clearance, endoscopic retrograde cholangiopancreatography (ERCP)-related adverse events, and late biliary complications during long-term follow-up were analyzed. RESULTS: Basic patient characteristics were not significantly different between the groups that underwent EPLBD (n = 168) and ES-LBD (n = 57). EPLBD compared with ES-LBD resulted in similar outcomes in terms of overall successful stone removal (99.4% vs. 100%, P = 1.00) and ERCP-related adverse events (7.7% vs. 5.3%, P = 0.77). The mean duration of the follow-up were 113.6 months and 106.7 months for patients with EPLBD and ES-LBD, respectively (P = 0.13). There was no significant difference between EPLBD and ES-LBD in the incidence of stone recurrence [20 (11.9%) vs. 9 (15.8%); P = 0.49]. Multivariate analysis showed that a diameter of CBD ≥ 15 mm (OR = 3.001; 95% CI: 1.357-6.640; P = 0.007) was an independent risk factor for stone recurrence. CONCLUSIONS: The application of a large balloon (12-15 mm) via EPLBD is an effective and safe alternative to ES-LBD for extraction of large CBD stones. Endoscopic sphincterotomy prior to EPLBD may be unnecessary. A diameter of CBD ≥ 15 mm is a risk factor of stone recurrence.

Successful hemostasis for post-endoscopic sphincterotomy bleeding following endoscopic papillary large balloon dilation using 12-mm-diameter fully covered self-expandable metal stent.

A 12-mm-diameter fully covered self-expandable metal stent may be effective for securing hemostasis in post-endoscopic sphincterotomy bleeding following endoscopic papillary large balloon dilation.

Risk Factors for Perforation During Endoscopic Papillary Large Balloon Dilation and Bile Duct Stone Removal.

BACKGROUND: Stone removal using endoscopic papillary large balloon dilation (EPLBD) is extremely effective. However, limited research exists regarding the risk factors for perforation of the duodenal papilla and bile duct, which may be fatal. AIMS: We aimed to investigate the risk factors for perforation during EPLBD + stone removal. METHODS: We included patients who underwent EPLBD + stone removal at four medical facilities between January 2008 and December 2018. We retrospectively analyzed the risk factors for perforation and their relationship between overdilation and adverse events. Overdilation was defined as a ratio of the balloon diameter to the diameter of the bile duct that exceeded 100%. The diameter of the distal bile duct was measured using the diameter of the intrapancreatic bile duct at a point 10 mm toward the liver from the narrow distal segment on a cholangiogram. RESULTS: We included 310 patients (177 males; median age: 79 years [range: 46-102 years]). Perforation occurred in five patients (1.6%). Multivariate analysis indicated that no surrounding-pancreas (half or less of the circumference of the intrapancreatic bile duct was surrounded by the pancreatic parenchyma) was a significant risk factor (perforation rate: 8.3%, p = 0.011, odds ratio: 12.7 [95% confidence interval: 1.8-90.5]). No significant difference was found between the overdilation and non-overdilation groups regarding the occurrence of pancreatitis, bleeding, and cholangitis. Perforation rate in patients with no surrounding pancreas + overdilation was 16.7% (2/12). Patients with perforation underwent conservative therapy, which improved their conditions. CONCLUSIONS: EPLBD + stone removal should be avoided in patients with no surrounding pancreas. Overdilation is not a risk factor for adverse procedural events; however, it should be limited in patients with surrounding pancreas.

Efficacy of endoscopic large balloon dilation extended for 2 minutes in bile duct stone removal: A multicenter retrospective study.

BACKGROUND/PURPOSE: There is no evidence regarding the optimal balloon dilation time during endoscopic papillary large balloon dilation (EPLBD). The study aim was to evaluate the efficacy of 2-minute extended balloon dilation for EPLBD. METHODS: Two hundred and five patients who underwent EPLBD during endoscopic retrograde cholangiopancreatography (ERCP) for bile duct stones at three tertiary centers were included in the analysis. Clinical outcomes and the adverse events were compared between the 0-minute group (n = 94, balloon deflated immediately after waist disappearance) and the 2-minute group (n = 111, balloon dilation maintained for 2 minutes after waist disappearance). The risk factors of post-ERCP pancreatitis (PEP) after EPLBD were assessed. RESULTS: There were no significant differences in the stone removal rates and hospitalization periods between the two groups. However, the total ERCP procedure time was significantly shorter in the 2-minute group (40.6 vs 48.9 min, P = .03). The incidence of PEP was 7.4% in the 0-minute group and significantly lower at 0.9% in the 2-minute group (P = .04). Multivariate analysis identified without 2-minute extended EPLBD as a significant risk factor of PEP (OR: 9.9, P = .045). CONCLUSIONS: Extension of EPLBD for 2 minutes helped prevent PEP and shortened the procedure time.

Immediate or Interval Endoscopic Papillary Large-balloon Dilation after Limited Endoscopic Sphincterotomy for Bile Duct Stone Removal.

Objective Endoscopic papillary large-balloon dilation (EPLBD) with limited endoscopic sphincterotomy (EST) is widely used for removing multiple large common bile duct (CBD) stones. However, the safety and effectiveness of immediate EPLBD after limited EST and EPLBD at an interval after limited EST is unclear. Thus, this multicenter retrospective study was conducted to examine this matter. Methods Propensity score-matching was performed to adjust the baseline characteristics between the immediate and interval EPLBD groups. We compared the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) complications and the early outcomes of ERCP between the 2 matched groups, which comprised 66 patients each. Results The complete stone clearance rate in each study group was 100%. The overall incidence of post-ERCP complications in the propensity score-matched interval and immediate EPLBD groups was 3/33 (9.1%) and 1/33 (3.0%), respectively (p=0.61). The immediate EPLBD group had significantly fewer mean ERCP sessions for complete stone removal and a significantly lower rate of endoscopic mechanical lithotripsy (EML) usage than the interval EPLBD group [1.6 vs. 2.4 sessions, p<0.001; and 4/33 (12.1%) vs. 12/33 (36.4%), p=0.042, respectively]. Conclusion The incidence of post-ERCP complications in the immediate EPLBD group was not significantly different from that in the interval EPLBD group. Compared with interval EPLBD, immediate EPLBD may result in a reduced number of ERCP sessions for complete stone clearance and reduce the rate of EML usage.

Dilation assisted stone extraction for complex biliary lithiasis: Technical aspects and practical principles.

Common bile duct stones are frequently diagnosed worldwide and are one of the main indications for endoscopic retrograde cholangio-pancreatography. Endoscopic sphincterotomy (EST) has been used for the removal of bile duct stones for the past 40 years, providing a wide opening to allow extraction. Up to 15% of patients present with complicated choledocholithiasis. In this context, additional therapeutic approaches have been proposed such as endoscopic mechanical lithotripsy, intraductal or extracorporeal lithotripsy, or endoscopic papillary large balloon dilation (EPLBD). EPLBD combined with EST was introduced in 2003 to facilitate the passage of large or multiple bile duct stones using a balloon greater than 12 mm in diameter. EPLBD without EST was introduced as a simplified technique in 2009. Dilation-assisted stone extraction (DASE) is the combination of two techniques: EPLBD and sub-maximal EST. Several studies have reported this technique as safe and effective in patients with large bile duct stones, without any increased risk of adverse events such as pancreatitis, bleeding, or perforation. Nevertheless, it is difficult to analyze the outcomes of DASE because there are no standard techniques and definitions between studies. The purpose of this paper is to provide technical guidance and specific information about the main issues regarding DASE, based on current literature and daily clinical experience in biliary referral centers.

Successful removal of multiple bile duct stones using a papillary large balloon dilation in a very elderly woman with situs inversus totalis.

Situs inversus totalis (SIT) is a rare congenital anomaly in which all viscera are transposed to the opposite side of the body. This uncommon anatomy causes technical difficulties in endoscopic treatment. A 98-year-old woman with SIT was admitted to our hospital complaining of upper abdominal pain and fever. Blood examinations and findings of abdominal computed tomography imaging confirmed the diagnosis of acute pancreatitis and cholangitis associated with biliary stones. After recovering from pancreatitis and cholangitis with conservative treatment, she underwent therapeutic endoscopic retrograde cholangiopancreatography (ERCP) to remove the common bile duct (CBD) stones. The patient and the endoscopist were positioned in the usual ERCP position, and the scope was inserted into the duodenum with an approach in the direction opposite to the routine practice. Biliary cannulation was performed in the direction of 1 o'clock, and the cholangiography showed remarkably dilated CBD filled with numerous stones. Endoscopic papillary large balloon dilation was performed, and the CBD stones were successfully removed. There were no complications, such as bleeding, pancreatitis, or perforation. Over 3 years of follow-up, she had no recurrence of cholangitis or pancreatitis.

Comparison of the Efficacy and Safety of Three Endoscopic Methods to Manage Large Common Bile Duct Stones: A Systematic Review and Network Meta-Analysis.

Background: The optimal choice of endoscopic method between endoscopic sphincterotomy (EST), endoscopic papillary large balloon dilation (EPLBD), and EST plus EPLBD (endoscopic sphincterotomy and large balloon dilation [ESLBD]) for patients with large common bile duct stones is unclear. Methods: We systematically searched MEDLINE, Scopus, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov from August 1, 1990 to December 1, 2019. Randomized clinical trials comparing at least two of the following methods EST, ESLBD, or EPLBD were included in this study. The primary outcomes were the overall success rate and initial success rate of common bile duct stone removal. Results: We identified 13 trials comprising 1990 patients. Regarding the overall success rate and initial success rate, EPLBD had the highest probability of being the most successful (surface under the cumulative ranking curve [SUCRA] = 82.8% and 52.9%, respectively) and the lowest probability of bleeding (53.8%). ESLBD had the highest probability (SUCRA) of having the lowest morbidity (88.8%), requiring mechanical lithotripsy (54.9%), perforation (68%), and the lowest mortality (89.3%). EST had the least probability of postendoscopic retrograde cholangiopancreatography pancreatitis and cholangitis (SUCRA: 66.4% and 62.3%, respectively). Conclusions: EPLBD was most successful, and ESLBD was safest for large common bile duct stones. Postendoscopic pancreatitis after EST was less common than that after EPLBD and ESLBD. However, more high-quality trials are required.

Balloons larger than 15 mm can increase the risk of adverse events following endoscopic papillary large balloon dilation.

BACKGROUND AND AIM: Although endoscopic papillary large balloon dilation (EPLBD) has been widely used to facilitate the removal of difficult common bile duct stones, however, the outcomes have not yet been investigated in terms of the diameter of the balloon used. We aimed to compare the clinical outcomes between EPLBD using smaller (12-15 mm, S-EPLBD) and larger balloons (> 15 mm, L-EPLBD). METHODS: Six hundred seventy-two patients who underwent EPLBD with or without endoscopic sphincterotomy for common bile duct stone removal were enrolled from May 2004 to August 2014 at four tertiary referral centers in Korea. The outcomes, including the initial success rate, the success rate without endoscopic mechanical lithotripsy, the overall success rate, and adverse events between S-EPLBD and L-EPLBD groups, were retrospectively compared. RESULTS: The initial success rate, the success rate without mechanical lithotripsy, the overall success rate, and the overall adverse events were not significantly different between the two groups. The rate of severe-to-fatal adverse events was higher in the L-EPBLD group than in the S-EPLBD group (1.6% vs 0.0%, 0.020). One case of severe bleeding and two cases of fatal perforation occurred only in the L-EPLBD group. In the multivariate analysis, the use of a > 15-mm balloon was the only significant risk factor for severe-to-fatal adverse events (>0.005, 23.8 [adjusted odds ratio], 2.6-214.4 [95% confidence interval]). CONCLUSIONS: L-EPLBD is significantly related to severe-to-fatal adverse events compared with S-EPLBD for common bile duct stone removal.

The efficacy of limited endoscopic sphincterotomy plus endoscopic papillary large balloon dilation for removal of large bile duct stones.

BACKGROUND: The removal of large bile duct stones (> 15 mm) by conventional endoscopic sphincterotomy (EST) and endoscopic papillary balloon dilation (EPBD) can be challenging, requiring mechanical lithotripsy (ML) in addition to EST or EPBD. The primary complication of ML is basket and stone impaction, which can lead to complications such as pancreatitis and cholangitis. The present study aims to investigate the efficacy of limited EST plus endoscopic papillary large balloon dilation (EST-EPLBD) for large bile duct stone extraction with an extent of cutting < 1/2 the length of the papillary mound. METHODS: We enrolled 185 patients with ≥15 mm bile duct stones who received EST, EPLBD and limited EST-EPLBD treatment from January 1, 2010 to February 28, 2018, at Kaohsiung Chang Gung Memorial Hospital (Kaohsiung, Taiwan). All patients were categorized into three groups: EST group (n = 31), EPLBD group (n = 96), and limited EST-EPLBD group (n = 58). The primary outcome variables were the success rate of complete stone removal and complications. RESULTS: The limited EST-EPLBD group exhibited a higher success rate of the first-session treatment compared with the EST and EPLBD groups (98.3% vs. 83.9% vs. 86.5%; P = 0.032) but required a longer procedure time (32 (12-61) min vs. 23.5 (17-68) min vs. 25.0 (14-60) min; P = 0.001). The need for ML during the procedure was 4 (12.9%) in the EST group, 10 (10.4%) in the EPLBD group and 2 (3.4%) in the limited EST-EPLBD group. Post-procedure bleeding in the EST group was more common than that in the limited EST-EPLBD group (9.7% vs. 0%; P = 0.038). Furthermore, dilated bile duct was the only risk factor for bile duct stone recurrence in the limited EST-EPLBD group. CONCLUSIONS: Limited EST-EPLBD exhibits a higher success rate but requires marginally longer procedure time for the first-session treatment. Furthermore, dilated bile duct is the only risk factor for bile duct stone recurrence in patients undergoing limited EST-EPLBD.

Endoscopic retrograde cholangiopancreatography, lights and shadows: Handle with care.

The role of endoscopic retrograde cholangiopancreatography (ERCP) has dramatically changed in the last years, mainly into that of a therapeutic procedure. The treatment of benign biliary disease, like "difficult" choledocolithiasis, with endoscopic papillary large balloon dilation combined with endoscopic sphinterotomy has proven an effective and safe technique. Moreover, safety in ERCP has improved as well, with the prevention of post-ERCP pancreatitis and patient-to-patient transmission of infections. The advent of self-expandable metal stenting has radically changed the management of biliopancreatic malignant strictures, while the role for therapy of benign strictures is still controversial. In addition, cholangioscopy (though the direct visualization of the biliopancreatic ductal system) has allowed for characterization of indeterminate biliary strictures and facilitated rescue therapy of large biliary stones deemed removable. Encouraging data from tissue ablation techniques, such as photodynamic therapy and radiofrequency ablation, need to be confirmed by large sample size clinical controlled trials. On the other hand, we have no drug-coated stents yet available to implant and evidence for the use of biodegradable stents is still weak. The competency and privileging of ERCP and endoscopic ultrasonography have been analyzed longer but the switch between the two procedures, at the same time, is becoming ordinary; as such, the endoscopist interested in this field should undergo parallel edification through training plans. Finally, the American Society for Gastrointestinal Endoscopy's statement on non-anesthesiologist administration of propofol for gastrointestinal endoscopy is not actually endorsed by the European Society of Anaesthesiology, having many medical-legal implications in some European countries.

Comparison of endoscopic papillary large balloon dilation with and without a prior endoscopic sphincterotomy for the treatment of patients with large and/or multiple common bile duct stones: a systematic review and meta-analysis.

AIM: To compare endoscopic papillary large balloon dilation (EPLBD) alone with EPLBD following endoscopic sphincterotomy (EST) in patients with large and/or multiple common bile duct stones. METHODS: We conducted a comprehensive search of PubMed, EMBASE, and the Cochrane Library database to identify relevant available articles until July 19, 2018. Complete common bile duct stone (CBDS) removal rate, frequency of mechanical lithotripsy (ML) usage, total procedure time and intra- and postoperative adverse events were analyzed. We used RevMan 5.3 to perform the pooled analyses. RESULTS: Seven RCTs matched the selection criteria. A total of 369 patients underwent EPLBD alone, and 367 patients underwent EPLBD following EST. Our meta-analysis revealed that there were no significant differences in terms of initial success rate (OR =0.69, 95% CI=0.44-1.09, P=0.11), frequency of ML usage (OR =1.18, 95% CI=0.68-2.05, P=0.55), rate of post-endoscopy pancreatitis (PEP) (OR =0.88, 95% CI=0.43-1.78, P=0.72), total procedure time (MD =1.52, 95% CI=-0.13-3.17, P=0.07), or other intra- and postoperative adverse events between the groups for patients with large and/or multiple CBDSs. CONCLUSIONS: EPLBD alone was comparable to EPLBD with prior EST in patients with large and/or multiple CBDSs. Further studies are required to confirm the mechanisms of PEP in patients who accept EPLBD during endoscopic retrograde cholangiopancreatography (ERCP).

Endoscopic Papillary Balloon Dilation/Endoscopic Papillary Large Balloon Dilation / 대한췌담도학회지

Endoscopic papillary balloon dilation (EPBD) and endoscopic papillary large balloon dilation (EPLBD) have been performed all around the world over several decades for the treatment of common bile duct stone. EPBD using small dilation balloon catheter can preserve sphincter of Oddi function and reduce the recurrence rate of bile duct stone compared to endoscopic sphincterotomy (EST). EPBD is a procedure with low risk of bleeding, which is appropriate for patients with coagulopathy, hepatic cirrhosis, end-stage of renal disease, and surgically altered anatomy such as Billroth II gastrectomy and periampullary diverticulum. However, it has a higher risk of postprocedure pancreatitis than EST. EPLBD using large balloon catheter (12 mm or more of diameter) is proper for more than 10 mm of common bile duct stone. The advantages of EPLBD are reduced need for mechanical lithotripsy with decreased procedure time and radiation exposure time irrespective of the precedence of EST. EPLBD also requires fewer endoscopic retrograde cholangiopancreatography sessions and is more cost-effective. The incidence of post-procedure pancreatitis is lower in EPLBD than EST. If EPBD and EPLBD are done under the guidelines, these would be safe and effective and may be alternatives to EST for common bile duct stone.

Endoscopic papillary large balloon dilation in patients with large biliary stones and periampullary diverticula: Results of a multicentric series.

INTRODUCTION: Stone extraction represents the most frequent indication for endoscopic retrograde cholangiopancreatography (ERCP). Endoscopic papillary large balloon dilation (EPLBD) is a recent introduced approach consisting of an endoscopic papillary large balloon dilation following limited endoscopic sphyncterotomy (ES), which has been proven to be safe and effective for extraction of large common bile duct (CBD) stones. Peri-ampullary diverticula (PAD) are described in 10-20% of patients undergoing ERCP. Aim of our study is to evaluate efficacy and safety of EPLBD for the extraction of large biliary stones in patients with PAD. METHODS: The prospectively collected endoscopy databases of 4 Italian ERCP high-volume centers were reviewed retrospectively, and all consecutive patients with an instrumental diagnosis of large biliary stones and PAD, between September 2014 and October 2016, were included in this study. RESULTS: Eighty-one patients (36 males, median age 75 years) were treated between September 2014 and October 2016. Deep biliary cannulation was reached in 78/80 patients. Successful extraction was achieved in 74/78 patients at the first attempt. AEs occurred in 8 patients (1 severe). Younger age, stone size and incomplete stone extraction were significantly associated with AEs. CONCLUSIONS: EPLBD is an effective and safe technique in patients with PAD and large biliary stones, which avoids the need of other techniques, thereby reducing the risks of adverse events.

Current endoscopic strategies for managing large bile duct stones.

Common bile duct stones are a relatively common occurrence and can often lead to devastating complications. Endoscopic retrograde cholangiopancreatography was introduced in the 1970s for management of common bile duct stones. Most common bile duct stones can be removed with simple techniques such as endoscopic sphincterotomy and balloon trawling. However, large bile duct stones continue to pose some difficulty in achieving complete extraction. In this article, we will review some of the established techniques such as the use of endoscopic papillary large balloon dilatation, mechanical lithotripsy, and cholangioscopy-assisted techniques. We will look at the recent literature to help clarify the particular methods and answer some of the questions surrounding these methods.

Endoscopic Management of Difficult Bile Duct Stones.

PURPOSE OF REVIEW: In 10-15% of the cases, conventional methods for removing bile duct stones by ERCP/balloon-basket extraction fail. The purpose of this review is to describe endoscopic techniques in managing these "difficult bile duct stones." RECENT FINDINGS: Endoscopic papillary large balloon dilation with balloon extraction ± mechanical lithotripsy is the initial approach used to retrieve large bile duct stones. With advent of digital cholangioscopy, electrohydraulic and laser lithotripsy are gaining popularity. Enteroscopy-assisted or laparoscopic-assisted approaches can be used for those with gastric bypass anatomy. Difficulties in removing bile duct stones can be related to stone-related factors such as the size and location of the stone or to altered anatomy such as stricture in the bile duct or Roux-en-Y anatomy. Several endoscopy approaches and techniques have described in the recent past that have greatly enhanced our ability to remove these "difficult" bile duct stones.

Japan Gastroenterological Endoscopy Society guidelines for endoscopic papillary large balloon dilation.

The Japan Gastroenterological Endoscopy Society has developed the 'EPLBD Clinical Practice Guidelines' as fundamental guidelines based on new scientific techniques. EPLBD is a treatment method that has recently become widely used for choledocolithiasis. The evidence level in this field is usually low, and in many instances, the recommendation grading has to be determined on the basis of expert consensus. At this point, the guidelines are divided into the following six sections according to the 'EST Clinical Practice Guidelines': (i) Indications, (ii) procedures, (iii) special cases, (iv) procedure-related adverse events, (v) treatment outcomes, and (vi) postoperative follow up observation.

Nasobiliary drainage can reduce the incidence of post-ERCP pancreatitis after papillary large balloon dilation plus endoscopic biliary sphincterotomy: a randomized controlled trial.

BACKGROUND AND AIMS: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis can be reduced following endoscopic papillary balloon dilation with the placement of an endoscopic nasobiliary drainage (ENBD) catheter. The aim of this study was to determine whether the placement of an ENBD reduces the risk of post-ERCP pancreatitis following endoscopic papillary large balloon dilation together with endoscopic biliary sphincterotomy. METHODS: A total of 160 patients with bile duct stones were randomly assigned (1:1) to an ENBD group or no-ENBD group. The primary outcome of this study was the incidence of post-ERCP pancreatitis. The secondary outcome was the incidence of post-ERCP hyperamylasemia. RESULTS: In total, 160 patients were randomized, and 155 were found to be eligible for the analysis. The two groups were similar regarding clinical and demographic factors as well as patient- and procedure-related risk factors for post-ERCP pancreatitis. Post-ERCP pancreatitis developed in 9 patients, that is, 8/77 (10.4%) of the control group and 1/78 (1.28%) of the ENBD group (p = .018; per protocol analysis). Intention to treat analysis also revealed that ENBD reduced the rate of post-ERCP pancreatitis (8/80 (10%) in the control group vs. 1/80 (1.25%) the ENBD group (p = .034)). Multivariate regression analysis identified not undergoing ENBD as an independent risk factor for post-ERCP pancreatitis (ENBD compared with no-ENBD: OR 0.087, 95% CI 0.011-0.734; p = .025). CONCLUSION: This study demonstrated that placement of an ENBD was effective and safe for the prevention of post-ERCP pancreatitis in patients undergoing endoscopic papillary large balloon dilation together with endoscopic biliary sphincterotomy.