Long-term prognosis and risk factors associated with post-ERCP pneumobilia in patients with common bile duct stones.

BACKGROUND AND AIMS: Post-ERCP pneumobilia is not uncommon; however, studies focusing on the long-term prognosis of patients with post-ERCP pneumobilia are limited. This study aimed to explore long-term prognosis and risk factors associated with post-ERCP pneumobilia in patients with common bile duct stones (CBDSs). METHODS: We conducted a retrospective analysis of 1380 patients who underwent ERCP for CBDSs at our hospital from January 2010 to December 2017. Patients were selected based on inclusion and exclusion criteria and divided into pneumobilia and nonpneumobilia groups, followed by propensity score matching. The matched groups were then compared in terms of incidence rates of both single and multiple recurrences of CBDSs, acute cholangitis, and acute cholecystitis. Multivariate logistic regression analysis was used to explore risk factors associated with pneumobilia. RESULTS: After propensity matching, there was no significant difference in the rate of single recurrence of CBDSs (22.5% vs 30%; P = .446) between the pneumobilia and nonpneumobilia groups. However, the incidences of multiple recurrences of CBDSs (32.5% vs 12.5%; P = .032) and acute cholangitis without stone recurrence (32.5% vs 2.5%; P = <.001) were significantly higher in the pneumobilia group. Based on multivariate logistic regression analysis, in addition to a dilated CBD (diameter of >1 cm) (odds ratio [OR], 2.48; 95% confidence interval [CI], 1.03-3.76; P = .043), endoscopic sphincterotomy with moderate incision (OR, 5.38; 95% CI, 1.14-25.47; P = .034) and with large incision (OR, 8.7; 95% CI, 1.83-41.46; P = .007) were identified as independent risk factors for pneumobilia after initial ERCP. CONCLUSIONS: Patients with post-ERCP pneumobilia have increased risk of multiple recurrences of CBDSs and acute cholangitis without stone recurrence. Independent risk factors for pneumobilia include peripapillary diverticulum, a dilated CBD (>1 cm), and endoscopic sphincterotomy with moderate and large incisions. A normal-sized CBD appears to serve as a secondary barrier against enterobiliary reflux, necessitating further research for confirmation.

Endoscopic minor papilla sphincterotomy in patients with complete pancreas divisum and acute recurrent pancreatitis: a metanalysis.

BACKGROUND AND AIMS: Pancreas divisum (PD) is a congenital variant of the pancreatic ductal system and a potential cause of acute recurrent pancreatitis (ARP). Endoscopic minor papilla sphincterotomy (MiES) is the most common procedure performed in the management of PD-related ARP. The aim of this study is to perform a meta-analysis estimating the efficacy and the safety of MiES in the management of patients with PD-related ARP. METHODS: A research was performed in Pubmed, EMBASE and Web of science, the studies were reviewed and selected according to inclusion and exclusion criteria. Evaluation of Heterogeneity and publication bias was performed, and a random effect model was used to estimate the effect size of each study. RESULTS: One hundred and thirteen articles were selected and reviewed, 13 met the inclusion criteria. All the studies were retrospective with a mean follow-up duration of 45.9 months. A total of 323 patients with PD-related ARP treated with MiES were included in the meta-analysis. The overall clinical success rate of MiES (defined as no further episodes of ARP, reduction of episodes of ARP, or improvement in quality of life) was of 77% (95%CI: 72%-81%; p = 0.30). Evaluating only the studies with clinical success rate defined as "no further AP in the follow-up" the clinical success rate was of 69.8% (95%CI: 61.3%-77.2%; p = 0.57), while evaluating the studies with other definitions (reduction of episodes of ARP or improvement in quality of life) the clinical success rate was of 81.2% (95%CI: 75.2%-86.1%; p = 0.45). The common fixed effects model disclosed a 25.5% overall adverse events rate (95%CI: 19.3%-32.8%; p = 0.42): acute pancreatitis in 14.3% (95%CI: 9.7%-20.6%; p = 0.36), bleeding in 5.6% (95%CI: 2.9%-10.4%; p = 0.98), and other adverse events in 5.6% (95%CI: 2.9%-10.4%; p = 0.67). CONCLUSION: MiES is an effective and relatively safe treatment in the management of PD-related ARP. The retrospective nature of the studies selected is the main limitations of this metanalysis. Prospective trials are needed to confirm these data.

Comparison of Outcomes between a Basket Catheter and a Balloon Catheter for Endoscopic Common Bile Duct Stone Removal.

INTRODUCTION: Evidence for the outcomes of endoscopic retrograde cholangiopancreatography (ERCP) between a basket catheter and a balloon catheter for endoscopic common bile duct stone (CBDS) removal is lacking. This study aimed to compare ERCP outcomes using a basket catheter and a balloon catheter for endoscopic CBDS removal. METHODS: This multicenter retrospective study included 904 consecutive patients with native papilla who underwent endoscopic stone removal for CBDS ≤10 mm using a basket catheter and/or a balloon catheter at three institutions in Japan. ERCP outcomes between the basket and balloon groups were compared using inverse probability of treatment weighting (IPTW) method. RESULTS: ERCP-related adverse events occurred in 6.5% (29/449) and 7.7% (35/455) of patients in the basket and balloon groups, respectively (IPTW-adjusted p = 0.52). The incidences of post-ERCP pancreatitis, cholangitis, and perforation were similar in the basket and balloon groups (3.8% vs. 2.9%, 1.3% vs. 0.9%, and 0.7% vs. 0.7%, respectively). However, bleeding incidences were significantly higher in the balloon group than in the basket group (3.3% vs. 0.7%, IPTW-adjusted p = 0.012). Successful complete stone removal at one ERCP session using a single catheter was achieved in 17.8% (80/449) in the basket group and in 81.3% (370/455) in the balloon group (IPTW-adjusted p < 0.001). DISCUSSION: A balloon catheter is more likely to complete stone extraction for CBDS ≤10 mm with a single catheter at one endoscopic stone removal session. However, the risk for post-ERCP bleeding is higher in the balloon group than in the basket group.

A Novel Dry Simulator Model for Learning Comprehensive Endoscopic Retrograde Cholangiopancreatography/Endoscopic Sphincterotomy Procedures while Minimizing Adverse Bleeding Events (with Video).

INTRODUCTION: Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST) are essential skills for performing endoscopic cholangiopancreatic procedures. However, these procedures have a high incidence of adverse events, and current training predominantly relies on patient-based approaches. Herein, we aimed to develop an ERCP/EST simulator model to address the need for safer training alternatives, especially for learners with limited ERCP experience. METHODS: The model was designed to facilitate the use of actual endoscopic devices, supporting learning objectives that align with the components of the validated Bethesda ERCP Skill Assessment Tool (BESAT). BESAT focuses on skills, such as papillary alignment, maintenance of duodenoscope position, gentle and efficient cannulation, controlled sphincterotomy in the correct trajectory, and guidewire manipulation. Thirty gastroenterology trainees used the simulator between May 2022 and March 2023, and their satisfaction was assessed using a visual analog scale (VAS) and pre- and post-training questionnaires. RESULTS: The novel simulator model comprised a disposable duodenal papillary section, suitable for incision with an electrosurgical knife, alongside washable upper gastrointestinal tract and bile duct sections for repeated use. The duodenal papillary section enabled reproduction of a realistic endoscope position and the adverse bleeding events due to improper incisions. The bile duct section allowed for the reproduction of fluoroscopic-like images, enabling learners to practice guidewire guidance and insertion of other devices. Following training, the median VAS score reflecting the expectation for model learning significantly increased from 69.5 (interquartile range [IQR]: 55.5-76.5) to 85.5 (IQR: 78.0-92.0) (p < 0.01). All participants expressed a desire for repeated simulator training sessions. CONCLUSIONS: This innovative simulator could serve as a practical educational tool, particularly beneficial for novices in ERCP. It could facilitate hands-on practice with actual devices, enhancing procedural fluency and understanding of precise incisions to minimize the risk of bleeding complications during EST.

Transpancreatic Sphincterotomy After Double Guidewire Technique Was Noninferior to Primary Transpancreatic Sphincterotomy in Difficult Biliary Cannulation.

BACKGROUND: When unintentional pancreatic duct access occurs during difficult biliary cannulation, the double guidewire (DGW) or transpancreatic sphincterotomy (TPS) may be utilized. DGW can be easily switched to TPS due to the existing guidewire in the pancreatic duct. However, the efficacy of TPS after DGW, named sequential DGW-TPS technique, versus primary TPS has not been assessed. AIMS: Our aim was to compare the benefits and adverse events of sequential DGW-TPS technique and primary TPS. METHODS: We performed a comparative retrospective cohort study that enrolled a total of 117 patients with native papillae. The patients were divided into one of 2 groups according to the primary bile duct access technique (sequential DGW-TPS or primary TPS), both with pancreatic stenting. RESULTS: Between November 2017 and May 2023, a total of 84 patients were grouped into sequential DGW-TPS and 33 into primary TPS. The overall post-ERCP pancreatitis (PEP) rate was 4.3% in the entire cohort, with no statistical differences were observed between the groups in terms of PEP rates (P = 0.927), PEP severity (P = 1.000), first biliary cannulation success (P = 0.621), overall cannulation success (P = 1.000), hyperamylasemia incidence (P = 0.241), elevated amylase levels (P = 0.881), and postoperative hospital stay (P = 0.185). Furthermore, these results remained consistent in multivariable regression analysis. CONCLUSIONS: The sequential DGW-TPS technique showed a comparable safety and biliary cannulation success rate to primary TPS in difficult biliary cannulation. Given the potential long-term complications associated with TPS, DGW should be first if inadvertent pancreatic access occurs, with TPS serving as second only if DGW fails.

Curative surgical treatment of common bile duct stones: Retrospective cohort study.

BACKGROUND: In the event of symptomatic common bile duct (CBD) stones with dilated CBD, one possible curative treatment option is stone extraction through choledocotomy associated with cholecystectomy. Endoscopic treatment is only reserved for residual stones at 6 weeks. The aim of this study was to evaluate the results from laparoscopic curative surgical treatment of CBD stones with dilated CBD. METHODS: This is a retrospective single-centered cohort study. All consecutive patients admitted for laparoscopic cholecystectomy with evidence of CBD stones with dilated CBD from January 2010 to December 2020 at our center were included. Success was defined by CBD clearance at 6 weeks. Need for additional procedures, such as endoscopic sphincterotomy, immediate, and end-of-procedure morbi-mortality as well as factors associated with procedure failure, were also studied. RESULTS: A total of 246 patients who received curative treatment were included in the study. The success rate for the curative treatment was 93.1% (229 patients). Immediate postoperative morbidity was 24.4% with a 5.3% reintervention rate. Immediate and 6-week postoperative mortality rates were zero and 0.4%, respectively. The mean length of stay was 11.3 days. Factors associated with procedure failure appeared to be the occurrence of an early postoperative complication and the need for readmission during the period between surgery and drain removal. CONCLUSION: This study indicates that laparoscopic curative surgical treatment for symptomatic CBD stones may be performed with acceptable results without routine need for additional procedures.

Endoscopic sphincterotomy for adults with biliary sphincter of Oddi dysfunction.

BACKGROUND: The sphincter of Oddi comprises a muscular complex encircling the distal part of the common bile duct and the pancreatic duct regulating the outflow from these ducts. Sphincter of Oddi dysfunction refers to the abnormal opening and closing of the muscular valve, which impairs the circulation of bile and pancreatic juices. OBJECTIVES: To evaluate the benefits and harms of any type of endoscopic sphincterotomy compared with a placebo drug, sham operation, or any pharmaceutical treatment, administered orally or endoscopically, alone or in combination, or a different type of endoscopic sphincterotomy in adults with biliary sphincter of Oddi dysfunction. SEARCH METHODS: We used extensive Cochrane search methods. The latest search date was 16 May 2023. SELECTION CRITERIA: We included randomised clinical trials assessing any type of endoscopic sphincterotomy versus placebo drug, sham operation, or any pharmaceutical treatment, alone or in combination, or a different type of endoscopic sphincterotomy in adults diagnosed with sphincter of Oddi dysfunction, irrespective of year, language of publication, format, or outcomes reported. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods and Review Manager to prepare the review. Our primary outcomes were: proportion of participants without successful treatment; proportion of participants with one or more serious adverse events; and health-related quality of life. Our secondary outcomes were: all-cause mortality; proportion of participants with one or more non-serious adverse events; length of hospital stay; and proportion of participants without improvement in liver function tests. We used the outcome data at the longest follow-up and the random-effects model for our primary analyses. We assessed the risk of bias of the included trials using RoB 2 and the certainty of evidence using GRADE. We planned to present the results of time-to-event outcomes as hazard ratios (HR). We presented dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean difference (MD) with their 95% confidence intervals (CI). MAIN RESULTS: We included four randomised clinical trials, including 433 participants. Trials were published between 1989 and 2015. The trial participants had sphincter of Oddi dysfunction. Two trials were conducted in the USA, one in Australia, and one in Japan. One was a multicentre trial conducted in seven US centres, and the remaining three were single-centre trials. One trial used a two-stage randomisation, resulting in two comparisons. The number of participants in the four trials ranged from 47 to 214 (median 86), with a median age of 45 years, and the mean proportion of males was 49%. The follow-up duration ranged from one year to four years after the end of treatment. All trials assessed one or more outcomes of interest to our review. The trials provided data for the comparisons and outcomes below, in conformity with our review protocol. The certainty of evidence for all the outcomes was very low. Endoscopic sphincterotomy versus sham Endoscopic sphincterotomy versus sham may have little to no effect on treatment success (RR 1.05, 95% CI 0.66 to 1.66; 3 trials, 340 participants; follow-up range 1 to 4 years); serious adverse events (RR 0.71, 95% CI 0.34 to 1.46; 1 trial, 214 participants; follow-up 1 year), health-related quality of life (Physical scale) (MD -1.00, 95% CI -3.84 to 1.84; 1 trial, 214 participants; follow-up 1 year), health-related quality of life (Mental scale) (MD -1.00, 95% CI -4.16 to 2.16; 1 trial, 214 participants; follow-up 1 year), and no improvement in liver function test (RR 0.89, 95% CI 0.35 to 2.26; 1 trial, 47 participants; follow-up 1 year), but the evidence is very uncertain. Endoscopic sphincterotomy versus endoscopic papillary balloon dilation Endoscopic sphincterotomy versus endoscopic papillary balloon dilationmay have little to no effect on serious adverse events (RR 0.34, 95% CI 0.04 to 3.15; 1 trial, 91 participants; follow-up 1 year), but the evidence is very uncertain. Endoscopic sphincterotomy versus dual endoscopic sphincterotomy Endoscopic sphincterotomy versus dual endoscopic sphincterotomy may have little to no effect on treatment success (RR 0.65, 95% CI 0.32 to 1.31; 1 trial, 99 participants; follow-up 1 year), but the evidence is very uncertain. Funding One trial did not provide any information on sponsorship; one trial was funded by a foundation (the National Institutes of Diabetes and Digestive and Kidney Diseases, NIDDK), and two trials seemed to be funded by the local health institutes or universities where the investigators worked. We did not identify any ongoing randomised clinical trials. AUTHORS' CONCLUSIONS: Based on very low-certainty evidence from the trials included in this review, we do not know if endoscopic sphincterotomy versus sham or versus dual endoscopic sphincterotomy increases, reduces, or makes no difference to the number of people with treatment success; if endoscopic sphincterotomy versus sham or versus endoscopic papillary balloon dilation increases, reduces, or makes no difference to serious adverse events; or if endoscopic sphincterotomy versus sham improves, worsens, or makes no difference to health-related quality of life and liver function tests in adults with biliary sphincter of Oddi dysfunction. Evidence on the effect of endoscopic sphincterotomy compared with sham, endoscopic papillary balloon dilation,or dual endoscopic sphincterotomyon all-cause mortality, non-serious adverse events, and length of hospital stay is lacking. We found no trials comparing endoscopic sphincterotomy versus a placebo drug or versus any other pharmaceutical treatment, alone or in combination. All four trials were underpowered and lacked trial data on clinically important outcomes. We lack randomised clinical trials assessing clinically and patient-relevant outcomes to demonstrate the effects of endoscopic sphincterotomy in adults with biliary sphincter of Oddi dysfunction.

Endoscopic sphincterotomy with balloon dilatation versus sphincterotomy alone for common bile duct stones removal: a randomised controlled trial.

INTRODUCTION: Endoscopic sphincterotomy (EST) plus endoscopic papillary large balloon dilatation (EPLBD) has been reported as a valid alternative to EST alone in removing common bile duct (CBD) stone. The aim of this study is to compare efficacy, and safety of these two groups of patients in removing CBD stone in Hospital Universiti Sains Malaysia (HUSM). MATERIALS AND METHODS: This is a prospective single centre randomised single blinded comparative study conducted in HUSM. The primary endpoints for this study are the overall complete stone clearance rate and complication rate, while the secondary outcome for this study are duration of procedure and rate of usage of adjunct methods. Objective data analysis is conducted using independent sample t-test and chi-squared test. RESULTS: A total of 66 patients underwent endoscopic retrograde cholangiopancreatography (ERCP) for choledocholithiasis which is CBD stone. 34 patients were allocated to EST plus EPLBD arm (n=34), and 32 patients were in EST alone arm (n=32) using randomisation method. For intention to treat, patients from EST alone arm that unable to achieve complete stone clearance will be switched to EST plus EPLBD arm. The overall complete stone removal rate for both groups were comparable (EST plus EPLDB: 100% versus EST alone: 93.8%; p= 0.139). The two patients from EST alone group (6.2%) that unable to achieve complete stone clearance were converted to EST plus EPLBD group for intention to treat and able to achieve complete stone clearance by EST plus EPLBD. For procedural time, both arms are comparable as well (EST plus EPLDB: 15.8 minutes vs EST alone: 15.5 minutes; p= 0.860). Complications such as pancreatitis occurred in one patient in EST plus EPLBD arm (EST plus EPLDB: 2.9 % vs EST alone: 0 %; p= 0.328), and bleeding occurred in one patient in EST alone arm (EST plus EPLDB: 0 % vs EST alone: 3.1 %; p= 0.299) , but it is not statistically significant. No perforation or cholangitis complication occurred in both groups. No adjunct usage was observed in both groups. CONCLUSION: In this study with limited sample size, both EST plus EPLBD and EST alone are effective and has comparable procedural time in removing CBD stone. Even though both methods are equally effective, EPLBD plus EST is an alternative solution if complete stone clearance is unable to achieve via EST alone.

Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study.

OBJECTIVE: Routine urgent endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic biliary sphincterotomy (ES) does not improve outcome in patients with predicted severe acute biliary pancreatitis. Improved patient selection for ERCP by means of endoscopic ultrasonography (EUS) for stone/sludge detection may challenge these findings. DESIGN: A multicentre, prospective cohort study included patients with predicted severe acute biliary pancreatitis without cholangitis. Patients underwent urgent EUS, followed by ERCP with ES in case of common bile duct stones/sludge, within 24 hours after hospital presentation and within 72 hours after symptom onset. The primary endpoint was a composite of major complications or mortality within 6 months after inclusion. The historical control group was the conservative treatment arm (n=113) of the randomised APEC trial (Acute biliary Pancreatitis: urgent ERCP with sphincterotomy versus conservative treatment, patient inclusion 2013-2017) applying the same study design. RESULTS: Overall, 83 patients underwent urgent EUS at a median of 21 hours (IQR 17-23) after hospital presentation and at a median of 29 hours (IQR 23-41) after start of symptoms. Gallstones/sludge in the bile ducts were detected by EUS in 48/83 patients (58%), all of whom underwent immediate ERCP with ES. The primary endpoint occurred in 34/83 patients (41%) in the urgent EUS-guided ERCP group. This was not different from the 44% rate (50/113 patients) in the historical conservative treatment group (risk ratio (RR) 0.93, 95% CI 0.67 to 1.29; p=0.65). Sensitivity analysis to correct for baseline differences using a logistic regression model also showed no significant beneficial effect of the intervention on the primary outcome (adjusted OR 1.03, 95% CI 0.56 to 1.90, p=0.92). CONCLUSION: In patients with predicted severe acute biliary pancreatitis without cholangitis, urgent EUS-guided ERCP with ES did not reduce the composite endpoint of major complications or mortality, as compared with conservative treatment in a historical control group. TRIAL REGISTRATION NUMBER: ISRCTN15545919.

Endoscopic Treatment of Large Bile Duct Stones: A Systematic Review and Network Meta-Analysis.

BACKGROUND & AIMS: Several endoscopic methods have been proposed for the treatment of large biliary stones. We assessed the comparative efficacy of these treatments through a network meta-analysis. METHODS: Nineteen randomized controlled trials (2752 patients) comparing different treatments for management of large bile stones (>10 mm) (endoscopic sphincterotomy, balloon sphincteroplasty, sphincterotomy followed by endoscopic papillary large balloon dilation [S+EPLBD], mechanical lithotripsy, single-operator cholangioscopy [SOC]) with each other were identified. Study outcomes were the success rate of stone removal and the incidence of adverse events. We performed pairwise and network meta-analysis for all treatments, and used Grading of Recommendations, Assessment, Development, and Evaluation criteria to appraise the quality of evidence. RESULTS: All treatments except mechanical lithotripsy significantly outperformed sphincterotomy in terms of stone removal rate (risk ratio [RR], 1.03-1.29). SOC was superior to other adjunctive interventions (vs balloon sphincteroplasty [RR, 1.24; 95% CIs, 1.07-1.45], vs S+EPLBD [RR, 1.23; range, 1.06-1.42] and vs mechanical lithotripsy [RR, 1.34; range, 1.14-1.58]). Cholangioscopy ranked the highest in increasing the success rate of stone removal (surface under the cumulative ranking [SUCRA] score, 0.99) followed by S+EPLBD (SUCRA score, 0.68). SOC and S+EPLBD outperformed the other modalities when only studies reporting on stones greater than 15 mm were taken into consideration (SUCRA scores, 0.97 and 0.71, respectively). None of the assessed interventions was significantly different in terms of adverse event rate compared with endoscopic sphincterotomy or with other treatments. Post-ERCP pancreatitis and bleeding were the most frequent adverse events. CONCLUSIONS: Among patients with large bile stones, cholangioscopy represents the most effective method, in particular in patients with larger (>15 mm) stones, whereas S+EPLBD could represent a less expensive and more widely available alternative.

AGA Clinical Practice Update on the Endoscopic Approach to Recurrent Acute and Chronic Pancreatitis: Expert Review.

DESCRIPTION: The purpose of this American Gastroenterological Association (AGA) Clinical Practice Update Expert Review is to provide practical, evidence-based guidance to clinicians regarding the role of endoscopy for recurrent acute and chronic pancreatitis. METHODS: This expert review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide guidance on a topic of clinical importance to the AGA membership, underwent internal peer review by the Clinical Practice Updates Committee (CPUC), and external peer review through standard procedures of Gastroenterology. This review is framed around the 8 best practice advice points agreed upon by the authors, based on the results of randomized controlled trials, observational studies, systematic reviews and meta-analyses, as well expert consensus in this field. Best Practice Advice Statements BEST PRACTICE ADVICE 1: After an unrevealing initial evaluation, endoscopic ultrasound is the preferred diagnostic test for unexplained acute and recurrent pancreatitis. Magnetic resonance imaging with contrast and cholangiopancreatography is a reasonable complementary or alternative test to endoscopic ultrasound, based on local expertise and availability. BEST PRACTICE ADVICE 2: The role of endoscopic retrograde cholangiopancreatography (ERCP) for reducing the frequency of acute pancreatitis episodes in patients with pancreas divisum is controversial, but minor papilla endotherapy may be considered, particularly for those with objective signs of outflow obstruction, such as a dilated dorsal pancreatic duct and/or santorinicele. There is no role for ERCP to treat pain alone in patients with pancreas divisum. BEST PRACTICE ADVICE 3: The role of ERCP for reducing the frequency of pancreatitis episodes in patients with unexplained recurrent acute pancreatitis and standard pancreatic ductal anatomy is controversial and should only be considered after a comprehensive discussion of the uncertain benefits and potentially severe procedure-related adverse events. When pursued, ERCP with biliary sphincterotomy alone may be preferable to dual sphincterotomy. BEST PRACTICE ADVICE 4: Surgical intervention should be considered over endoscopic therapy for long-term treatment of patients with painful obstructive chronic pancreatitis. Endoscopic intervention is a reasonable alternative to surgery for suboptimal operative candidates or those who favor a less invasive approach, assuming they are clearly informed that the best practice advice primarily favors surgery. BEST PRACTICE ADVICE 5: When ERCP is pursued, small (≤5mm) main pancreatic duct stones can be treated with pancreatography and conventional stone extraction maneuvers. For larger stones, extracorporeal shockwave lithotripsy and/or pancreatoscopy with intraductal lithotripsy may be required. BEST PRACTICE ADVICE 6: When ERCP is pursued, prolonged stent therapy (6-12 months) is effective for treating symptoms and remodeling main pancreatic duct strictures. The preferred approach is to place and sequentially add multiple plastic stents in parallel (upsizing); emerging evidence suggests that fully covered self-expanding metal stents may have a role for this indication, but additional research is necessary. BEST PRACTICE ADVICE 7: ERCP with stent insertion is the preferred treatment for benign biliary stricture due to chronic pancreatitis. FCSEMS placement is favored over multiple plastic stents whenever feasible, given similar efficacy but significantly reduced need for stent exchange procedures during the treatment course. BEST PRACTICE ADVICE 8: Celiac plexus block should not be routinely performed for the management of pain due to chronic pancreatitis. The decision to proceed with celiac plexus block in selected patients with debilitating pain in whom other therapeutic measures have failed can be considered on a case-by-case basis, but only after discussion of the unclear outcomes of this intervention and its procedural risks.

Pure Cut or Endocut for Biliary Sphincterotomy? A Multicenter Randomized Clinical Trial.

INTRODUCTION: Adverse events (AE) after endoscopic retrograde cholangiopancreatography (ERCP) are not uncommon and post-ERCP acute pancreatitis (PEP) is the most important one. Thermal injury from biliary sphincterotomy may play an important role and trigger PEP or bleeding. Therefore, this study evaluated the outcomes of 2 electric current modes used during biliary sphincterotomy. METHODS: From October 2019 to August 2021, consecutive patients with native papilla undergoing ERCP with biliary sphincterotomy were randomized to either the pure cut or endocut after cannulation. The primary outcome was PEP incidence. Secondary outcomes included intraprocedural and delayed bleeding, infection, and perforation. RESULTS: A total of 550 patients were randomized (272 pure cut and 278 endocut). The overall PEP rate was 4.0% and significantly higher in the endocut group (5.8% vs 2.2%, P = 0.034). Univariate analysis revealed >5 attempts ( P = 0.004) and endocut mode ( P = 0.034) as risk factors for PEP. Multivariate analysis revealed >5 attempts ( P = 0.005) and a trend for endocut mode as risk factors for PEP ( P = 0.052). Intraprocedural bleeding occurred more often with pure cut ( P = 0.018), but all cases were controlled endoscopically during the ERCP. Delayed bleeding was more frequent with endocut ( P = 0.047). There was no difference in perforation ( P = 1.0) or infection ( P = 0.4999) between the groups. DISCUSSION: Endocut mode may increase thermal injury leading to higher rates of PEP and delayed bleeding, whereas pure cut is associated with increased intraprocedural bleeding without clinical repercussion. The electric current mode is not related to perforation or infection. Further RCT assessing the impact of electric current on AE with overlapping preventive measures such as rectal nonsteroidal anti-inflammatory drugs and hyperhydration are needed. The study was submitted to the Brazilian Clinical Trials Platform ( http://www.ensaiosclinicos.gov.br ) under the registry number RBR-5d27tn.

Design and execution of sham-controlled endoscopic trials in acute pancreatitis: Lessons learned from the SHARP trial.

Using the ongoing NIDDK-funded multicenter randomized clinical trial, Sphincterotomy for Acute Recurrent Pancreatitis (SHARP) as an example, this article discusses the rationale and key aspects of study design that need to be considered when conducting a clinical trial of endoscopic therapy in acute pancreatitis. SHARP, the first trial using a sham ERCP in the placebo group, is designed to address a decades long controversy in clinical pancreatology, i.e. whether minor papilla sphincterotomy benefits patients with idiopathic acute recurrent pancreatitis who also have pancreas divisum. Although the trial has already enrolled and randomized over 5 times the number of subjects enrolled in the only randomized trial in this area published in 1992 (107 vs. 19), recruitment has been challenging and we are at ∼46% of target recruitment. The review discusses the challenges in the execution of the trial and strategies the SHARP team has used to address these, which investigators planning or considering treatment trials in pancreatitis may find helpful. It will also inform the general gastroenterologists the importance of discussing and referring potentially eligible subjects to centers participating in clinical trials. Developing evidence-based treatment will provide a solid scientific basis for physicians to recommend evidence-based treatments for pancreatitis.

Safety and efficacy of minor papillotomy in children and adolescents with pancreas divisum.

INTRODUCTION: Pancreas Divisum (PD) is a common pancreatic ductal variant which is twice as common in pediatric patients with acute recurrent pancreatitis (ARP) relative to the general population (14% vs. 7%). Endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy has been performed to facilitate drainage of pancreatic juice from the diminutive minor papilla to prevent pancreatitis and pancreatic damage. METHODS: We searched our prospectively-maintained endoscopy databases for patients 18 and younger who underwent ERCP with minor papillotomy between 2009 and 2019. Demographic data, indications, procedural interventions and findings, as well as available clinical outcomes data were analyzed. RESULTS: 54 ARP/PD patients underwent ERCP with minor papillotomy. Median age was 14 (range 7-18) years, and 26 (48.1%) patients were female. Post-ERCP pancreatitis developed in 10/54 patients (18.5%). 12-month post-ERCP clinical trajectory was available in 47/54 (87%) patients and most patients (38/47, 80.8%) improved clinically after minor papillotomy, with 9/47 (19.1%) experiencing resolution of pancreatitis episodes and none indicated worsening severity or frequency of pancreatitis episodes following ERCP. CONCLUSION: The majority of children and adolescents with PD and ARP who underwent ERCP with minor papillotomy experienced subjective improvement in their symptoms following the intervention. These data suggest that ERCP with minor papillotomy for pediatric patients with PD and ARP is beneficial and may be curative in a subset of patients-higher rates of improvement than have been previously reported in adults.

Initial experience of visualized biliary cannulation during ERCP.

BACKGROUND : Selective biliary cannulation is the most challenging step in endoscopic retrograde cholangiopancreatography (ERCP) because only indirect radiographic images can be obtained. Therefore, we developed a novel endoscopic retrograde direct cholangioscopy (ERDC) technology to facilitate visible biliary cannulation. METHODS : In this case series, we used ERDC to treat 21 patients with common bile duct stones who were enrolled consecutively between July 2022 and December 2022. The procedure details and complications were recorded, and all patients were followed up for 3 months after the procedure. The learning curve effect was analyzed by comparing the early and later cases. RESULTS : Biliary cannulation was successful in all patients, and the stones were removed completely. The median (interquartile range [IQR]) time for cholangioscopy-guided biliary cannulation was 240.0 (10.0-430.0) seconds, and the median (IQR) number of cannulation procedures was 2 (1-5). Despite there being one episode of post-ERCP pancreatitis, one of cholangitis, and three patients developing asymptomatic hyperamylasemia, all of the patients recovered after symptomatic treatment, being discharged and with no serious adverse events occurring during the 3-month follow-up period. Compared with the early cases, the number of intubations and the use of guidewire guidance decreased in later cases. CONCLUSION : Our research confirms that ERDC is a feasible technology for biliary cannulation under direct vision.

An artificial intelligence difficulty scoring system for stone removal during ERCP: a prospective validation.

BACKGROUND: A computer-assisted (CAD) system was developed to assess, score, and classify the technical difficulty of common bile duct (CBD) stone removal during endoscopic retrograde cholangiopancreatography (ERCP). The efficacy of the CAD system was subsequently assessed through a multicenter, prospective, observational study. METHOD: All patients who met the inclusion criteria were included. Based on cholangiogram images, the CAD system analyzed the level of difficulty of stone removal and classified it into "difficult" and "easy" groups. Subsequently, differences in clinical endpoints, including attempts at stone extraction, stone extraction time, total operation time, and stone clearance rates were compared between the two groups. RESULTS: 173 patients with CBD stones from three hospitals were included in the study. The group classified as difficult by CAD had more extraction attempts (7.20 vs. 4.20, P < 0.001), more frequent machine lithotripsy (30.4 % vs. 7.1 %, P < 0.001), longer stone extraction time (16.59 vs. 7.69 minutes, P < 0.001), lower single-session stone clearance rate (73.9 % vs. 94.5 %, P < 0.001), and lower total stone clearance rate (89.1 % vs. 97.6 %, P = 0.019) compared with the group classified as easy by CAD. CONCLUSION: The CAD system effectively assessed and classified the degree of technical difficulty in endoscopic stone extraction during ERCP. In addition, it automatically provided a quantitative evaluation of CBD and stones, which in turn could help endoscopists to apply suitable procedures and interventional methods to minimize the possible risks associated with endoscopic stone removal.

Comparison of the Efficacy of Endoscopic Radial Incision and Cutting Procedure and Endoscopic Balloon Dilation for Benign Anastomotic Stricture After Low Anterior Resection Combined With Preventive Loop Ileostomy in Rectal Cancer.

BACKGROUND: Endoscopic radial incision and cutting procedure is a notable technique in the treatment of benign anastomotic strictures after low anterior resection in rectal cancer. However, the efficacy and safety of the endoscopic radial incision and cutting procedure and traditional endoscopic balloon dilation remain unknown. OBJECTIVE: To compare the efficacy and safety of the endoscopic radial incision and cutting procedure and endoscopic balloon dilation in patients with anastomotic stricture after low anterior resection. DESIGN: Rectal cancer patients with anastomotic stricture after low anterior resection combined with synchronous preventive loop ileostomy between January 2014 and June 2021 were retrospectively collected. These patients underwent the endoscopic radial incision and cutting procedure or endoscopic balloon dilation as an initial treatment. The clinicopathological baseline data of the patients, endoscopic surgery success rate, complications, and restricture rate were analyzed. SETTINGS: This study was conducted at Nanfang Hospital in China. PATIENTS: A total of 30 patients were eligible after reviewing the medical records. Twenty patients underwent endoscopic balloon dilation, and 10 patients underwent endoscopic radial incision and cutting procedure. MAIN OUTCOME MEASURES: The adverse event rate and stricture recurrence rate. RESULTS: There were no significant differences in patient demographics or clinical features. No adverse events occurred in either of the 2 groups. The mean operation time was 18.9 ± 3.6 minutes in the endoscopic balloon dilation group and 10.2 ± 3.3 minutes in the endoscopic radial incision and cutting procedure group ( p < 0.001). The stricture recurrence rates between the endoscopic balloon dilation group and the endoscopic radial incision and cutting procedure group were significantly different (44.4% vs 0%; p = 0.025). LIMITATIONS: This was a retrospective study. CONCLUSIONS: The endoscopic radial incision and cutting procedure is safe and more efficacious than endoscopic balloon dilation for anastomotic stricture after low anterior resection combined with synchronous preventive loop ileostomy in rectal cancer.

Enlarged fistulotomy of the papilla as access to the biliary tract during ERCP.

BACKGROUND: Demonstration of access to the bile duct through Enlarged Papillary Fistulotomy, a method different from conventional fistulotomy. AIMS: Demonstration of the EFP technique with dissection in layers of the papilla for accessing the common bile duct, its efficiency and safety, rescue of cases of failure in cannulation and cases of access failure by EFP in the first attempt, facilitating cannulation in the second attempt. METHODS: Cross-sectional study, with retrospective data collection from 2233 ERCP exams with 528 EFP procedures, analysis of success and complications. RESULTS: 528 patients underwent EFP on the first attempt, with success in 465 cases (88.06%) and 63 failures (11.94%). Of these failures, 33 patients (52.38%) returned for a second EFP attempt, with success in 30 cases (90.9%) and failure in 3 cases (9.1%). Deep bile duct cannulation was achieved in 93.75% of EFP procedures, and cannulation failure occurred in 33 cases (6.25%). CONCLUSION: EFP showed efficiency in CBD cannulation, did not induce post-ERCP pancreatitis, no cases of perforation or false tract, but resulted in higher rates of minor bleeding, rescued cases of access failure by EFP, facilitated the posterior approach on the second attempt, it is safe, effective, low risk and associated with few comorbidities.

Large common bile duct stones in high-risk elderly patients: Immediate endoscopic stone removal or elective stone removal? A single-center retrospective study.

BACKGROUND AND OBJECTIVE: For high-risk elderly patients with chronic diseases, endoscopic stone removal for large common bile duct stones is associated with a high risk of adverse events and incomplete stone removal. The aim of this study was to investigate whether the treatment strategy of short-term biliary plastic stent placement followed by elective endoscopic stone removal is more effective and safer than immediate endoscopic stone removal. METHODS: The data of 262 high-risk elderly patients who received endoscopic retrograde cholangiopancreatography (ERCP) for large common bile duct (CBD) stones from 2017 to 2022 were retrospectively analyzed. The patients were divided into group A (immediate stone removal) and group B (stent drainage + elective stone removal). The baseline data of the 2 groups were matched 1:1 by propensity score matching. The stone clearance rate, ERCP procedure time, total hospital stay, and procedure-related adverse events were compared between the matched groups. In group B, stone size before and after stent placement, hospital stay, procedure time and adverse events of two ERCPs were compared. RESULTS: A total of 57 pairs of patients were successfully matched between the 2 groups. The stone clearance rate in group B was higher than that in group A (89.5% vs. 75.3, P = 0.049). The total hospital stay in group B was longer than that in group A (11.86 ± 3.912 d vs. 19.14 ± 3.176 d, P<0.001). The total adverse event rate in group A was higher than that in group B (29.8% vs. 12.3%, P = 0.005). The incidence of cholangitis/cholecystitis after ERCP was significantly higher in group A than in group B (7.0% vs. 0.9% P = 0.029). There was no significant difference in the incidence of post-ERCP pancreatitis, bleeding, pneumonia, and cardio-cerebrovascular events between the 2 groups. There were no perforation cases in either group. After plastic biliary stent placement in group B, the stone size was significantly smaller than before stent placement (1.59 ± 0.544 cm vs. 1.95 ± 0.543 cm, P < 0.001), and there was no significant difference in the total adverse event incidence between the two ERCP procedures (18.8% vs. 10.9%, P = 0.214). CONCLUSION: For high-risk elderly patients with large CBD stones, the treatment strategy involving temporary placement of plastic stent and elective endoscopic stone removal is safer and more effective than immediate stone removal.

Comparison between Transpancreatic Sphincterotomy and Needle-Knife Precut in Difficult Cannulation of Endoscopic Retrograde Cholangiopancreatography: An Up-To-Date Meta-Analysis and Systematic Review.

BACKGROUND: Selective cannulation, which is essential for endoscopic retrograde cholangiopancreatography (ERCP), may be difficult. The aim of this study was to compare transpancreatic sphincterotomy (TPS) and needle-knife precut (NKP) in difficult cannulation during ERCP. METHODS: PubMed, Embase, Web of Science, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched for relevant studies from January 1990 to April 2022. A meta-analysis focusing on cannulation success and post-ERCP complications was performed using Review Manager. RESULTS: Seventeen eligible studies involving 2,340 patients were included. Our results showed that the TPS group had a higher cannulation success rate (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.27-0.87, p = 0.02) and less bleeding (OR 1.94, 95% CI: 1.09-3.47, p = 0.03) compared with the NKP group. There was no significant difference between NKP and TPS in the rates of post-ERCP pancreatitis (OR 0.83, 95% CI: 0.59-1.18, p = 0.30), perforation (OR 2.04, 95% CI: 0.69-6.03, p = 0.20), and adverse events (OR 1.29, 95% CI: 0.94-1.77, p = 0.12). CONCLUSION: TPS appears to be associated with a higher cannulation success rate and less bleeding than those with NKP, with equal post-ERCP pancreatitis, perforation, and adverse event rates between TPS and NKP. Further large-scale trials are warranted to support our findings.