High Risk Of post-ERCP Pancreatitis Research Articles

Endoscopic sphincterotomy to prevent post-ERCP pancreatitis after self-expandable metal stent placement for distal malignant biliary obstruction (SPHINX): a multicentre, randomised controlled trial

BackgroundEndoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS...

S1542 Biliary Access Using Needle Knife Fistulotomy as an Initial Method of Cannulation in Patients With Average and High Risk of Post-ERCP Pancreatitis

S1542 Biliary Access Using Needle Knife Fistulotomy as an Initial Method of Cannulation in Patients With Average and High Risk of Post-ERCP Pancreatitis

Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial

The combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention. In this randomised, non-inferiority trial conducted at 20 referral centres in the USA and Canada, patients (aged ≥18 years) at high risk for post-ERCP pancreatitis were randomly assigned (1:1) to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent. Patients, treating clinicians, and outcomes assessors were masked to study group assignment. The primary outcome was post-ERCP pancreatitis. To declare non-inferiority, the upper bound of the two-sided 95% CI for the difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) would have to be less than 5% (non-inferiority margin) in both the intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov (NCT02476279), and is complete. Between Sept 17, 2015, and Jan 25, 2023, a total of 1950 patients were randomly assigned. Post-ERCP pancreatitis occurred in 145 (14·9%) of 975 patients in the indomethacin alone group and in 110 (11·3%) of 975 in the indomethacin plus stent group (risk difference 3·6%; 95% CI 0·6-6·6; p=0·18 for non-inferiority). A post-hoc intention-to-treat analysis of the risk difference between groups showed that indomethacin alone was inferior to the combination of indomethacin plus prophylactic stent (p=0·011). The relative benefit of stent placement was generally consistent across study subgroups but appeared more prominent among patients at highest risk for pancreatitis. Safety outcomes (serious adverse events, intensive care unit admission, and hospital length of stay) did not differ between groups. For preventing post-ERCP pancreatitis in high-risk patients, a strategy of indomethacin alone was not as effective as a strategy of indomethacin plus prophylactic pancreatic stent placement. These results support prophylactic pancreatic stent placement in addition to rectal indomethacin administration in high-risk patients, in accordance with clinical practice guidelines. US National Institutes of Health.

Incidence, severity, and mortality of post-ERCP pancreatitis: an updated systematic review and meta-analysis of 145 randomized controlled trials.

The incidence, severity, and mortality of post-ERCP pancreatitis (PEP) largely remain unknown with changing trends in ERCP use, indication, and techniques. We sought to determine the incidence, severity, and mortality of PEP in consecutive and high-risk patients based on a systemic review and meta-analysis of patients in placebo and no-stent arms of randomized control trials (RCTs). The MEDLINE, Embase, and Cochrane databases were searched from the inception of each database to June 2022 to identify full-text RCTs evaluating PEP prophylaxes. The incidence, severity, and mortality of PEP from the placebo or no-stent arms of RCTs were recorded for consecutive and high-risk patients. A random-effects meta-analysis for a proportions model was used to calculate PEP incidence, severity, and mortality. One hundred forty-five RCTs were found with 19,038 patients in the placebo or no-stent arms. The overall cumulative incidence of PEP was 10.2% (95% confidence interval [CI], 9.3-11.3), predominantly among the academic centers conducting such RCTs. The cumulative incidences of severe PEP and mortality were .5% (95% CI, .3-.7) and .2% (95% CI, .08-.3), respectively, across 91 RCTs with 14,441 patients. The cumulative incidences of PEP and severe PEP were 14.1% (95% CI, 11.5-17.2) and .8% (95% CI, .4-1.6), respectively, with a mortality rate of .2% (95% CI, 0-.3) across 35 RCTs with 3733 patients at high risk of PEP. The overall trend for the incidence of PEP among patients randomized to placebo or no-stent arms of RCTs has remained unchanged from 1977 to 2022 (P= .48). The overall incidence of PEP is 10.2% but is 14.1% among high-risk patients based on this systematic review of placebo or no-stent arms of 145 RCTs; this rate has not changed between 1977 and 2022. Severe PEP and mortality from PEP are relatively uncommon.

OGBN P21 A complex case of gallbladder and CBD stones treated with Laparoscopic Cholecystectomy and Trans-Cystic lithotripsy using SpyGlass™ Discover post failed ERCP

Abstract Background Laparoscopic Cholecystectomy and bile duct exploration remain the gold standard treatment for gallstone disease associated with bile duct stones. However, interval two session management with ERCP followed by Laparoscopic Cholecystectomy should be avoided. It exposes patients to preventable risk of perforation, bleeding, and pancreatitis, especially if the patient is fit and keen for surgery. Trans-Cystic bile duct exploration (TC BDE) appears to have less morbidity than Trans- Ductal bile duct exploration (TD BDE). However, large bile duct stones remain the main challenge for Trans-Cystic approach along with distorted anatomy. Methods We present a 48-year-old female with symptomatic gallstone disease and a complex past surgical history. Results Trial of ERCP failed despite Needle-knife papillotomy due to large mobile and hard papilla. Unfortunately, the patient suffered post ECRP pancreatitis that was complicated by an abdominal collection around the head of the pancreas. The collection required radiologic drainage through the anterior abdominal wall, 13 days post-pancreatitis. The patient recovered well and was listed for a Laparoscopic Cholecystectomy and bile duct exploration with high risk of conversion to open, 6 weeks after discharge. The operation was challenging due to presence of adhesions and shrunken gallbladder (Nassar grade IV). Trans-Cystic BDE was performed using basket inside catheter (BIC) technique. SpyGlass™ Discover choledochoscopy showed a clear distal CBD and a large 12mm stone in the common hepatic duct. The stone was hard and required a high setting of lithotripsy (30, Max). The stone was fragmented successfully, and all fragments extracted using baskets. The cystic duct was closed by suturing using 3.0 Vicryl and two Robinson abdominal drains were left in the abdomen; one in Morrison's pouch and one in the sub-diaphragmatic space. The patient had an uncomplicated post-operative recovery and was discharged home after 5 days. Follow-up 8 months later was satisfactory. Conclusions Trans-Cystic bile duct exploration has become increasingly safe and feasible even for large bile duct stones using new technology. ERCP should be avoided in young fit patients, especially females due to the higher risk of post-ERCP pancreatitis.

Selective indications of indomethacin and somatostatin, alone or in combination, and their preventive effects in patients at high risk for post-ERCP pancreatitis

Selective indications of indomethacin and somatostatin, alone or in combination, and their preventive effects in patients at high risk for post-ERCP pancreatitis

Troubleshooting Difficult Bile Duct Access: Advanced ERCP Cannulation Techniques, Percutaneous Biliary Drainage, or EUS-Guided Rendezvous Technique?

Despite experienced hands and availability of various well-designed catheters and wires, selective bile duct cannulation may still fail in 10–20% of cases during endoscopic retrograde cholangiopancreatography (ERCP). In case standard ERCP cannulation technique fails, salvage options include advanced ERCP cannulation techniques such as double-guidewire technique (DGW) with or without pancreatic stenting and precut papillotomy, percutaneous biliary drainage (PBD), and endoscopic ultrasound-guided Rendezvous (EUS-RV) ERCP. If the pancreatic duct is inadvertently entered during cannulation attempts, DGW technique is a reasonable next step, which can be followed by pancreatic stenting to reduce risks of post-ERCP pancreatitis (PEP). Studies suggest that early precut papillotomy is not associated with a higher risk of PEP, while needle-knife fistulotomy is the preferred method. For patients with critical clinical condition who may not be fit for endoscopy, surgically altered anatomy in which endoscopic biliary drainage is not feasible, and non-communicating multisegmental biliary obstruction, PBD has a unique role to provide successful biliary drainage efficiently in this particular population. As endoscopic ultrasound (EUS)-guided biliary drainage techniques advance, EUS-RV ERCP has been increasingly employed to guide bile duct access and cannulation with satisfactory clinical outcomes and is especially valuable for benign pathology at centres where expertise is available. Endoscopists should become familiar with each technique’s advantages and limitations before deciding the most appropriate treatment that is tailored to patient’s anatomy and clinical needs.

S3367 Obesity and In-Hospital Outcomes of Endoscopic Retrograde Cholangiopancreatography

Introduction: Multiple risk factors associated with post-Endoscopic Retrograde Cholangiopancreatography (ERCP) complications have been investigated in numerous studies. However, there are only a few studies focusing on the relationship between obesity and ERCP outcomes. In our study, we compared the in-hospital outcomes of ERCP in obese vs non-obese patients. Methods: The study cohort is derived from the Nationwide Inpatient Sample (NIS) for the years 2007-2018. Adult patients undergoing ERCP were identified using previously validated ICD-9-CM/ICD-10-CM codes. Procedural complications and other diagnoses of interest were also identified by ICD-9/10-CM codes. We utilized the Chi-Square test, Wilcoxon Rank Sum test, and multivariable survey logistic regression models to analyze the data. Results: We analyzed 1,973,398 ERCP procedures from 2007-2018, out of which 279,620 (14.2%) were performed in obese patients. Proportion of obese patients undergoing ERCP increased from 7.6% in 2007 to 20.0% in 2018 (P < 0.01). Obese patients under going ERCP were younger (53-years vs 60-years; P < 0.01), female (68% vs 57%: P < 0.01) and Hispanic (18% vs 15%; P < 0.01). In univariate analysis, obesity was associated with higher post-ERCP pancreatitis (2.0% vs 1.6%; P < 0.001). Even after adjusting for confounding factors, obesity was associated with a higher risk of post-ERCP pancreatitis (1.2; 95%CI 1.1-1.3; P < 0.01). Detailed comparison of in-hospital outcomes of ERCP in obese vs non-obese has been depicted in Table. Conclusion: We demonstrated the in-hospital outcomes of ERCP in obese vs non-obese patients and found out that obesity is an independent risk factor for post-ERCP pancreatitis and cholangitis. Our study highlights the need for focused interventions to reduce the incidence of these complications to improve the overall outcomes of ERCP in obese patients.Table 1.: In-Hospital Outcomes of ERCP in Obese vs Non- Obese patients.

Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial

Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Prophylactic rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs) is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration might further reduce this risk. Guidelines already recommend aggressive hydration in patients who are unable to receive rectal NSAIDs, although it is laborious and time consuming. We aimed to evaluate the added value of aggressive hydration in patients receiving prophylactic rectal NSAIDs. FLUYT, a multicentre, open-label, randomised, controlled trial done across 22 Dutch hospitals, included patients aged between 18 and 85 years with moderate to high risk of post-ERCP pancreatitis. Patients were randomly assigned (1:1) by a web-based module with varying block sizes to a combination of aggressive hydration and rectal NSAIDs (100 mg diclofenac or indomethacin; aggressive hydration group) or rectal NSAIDs (100 mg diclofenac or indomethacin) alone (control group). Randomisation was stratified according to treatment centre. Aggressive hydration comprised 20 mL/kg intravenous Ringer's lactate solution within 60 min from the start of ERCP, followed by 3 mL/kg per h for 8 h. The control group received normal intravenous saline with a maximum of 1·5 mL/kg per h and 3 L per 24 h. The primary endpoint was post-ERCP pancreatitis and was analysed on a modified intention-to-treat basis (including all patients who underwent randomisation and an ERCP and for whom data regarding the primary outcome were available). The trial is registered with the ISRCTN registry, ISRCTN13659155. Between June 5, 2015, and June 6, 2019, 826 patients were randomly assigned, of whom 388 in the aggressive hydration group and 425 in the control group were included in the modified intention-to-treat analysis. Post-ERCP pancreatitis occurred in 30 (8%) patients in the aggressive hydration group and in 39 (9%) patients in the control group (relative risk 0·84, 95% CI 0·53-1·33, p=0·53). There were no differences in serious adverse events, including hydration-related complications (relative risk 0·99, 95% CI 0·59-1·64; p=1·00), ERCP-related complications (0·90, 0·62-1·31; p=0·62), intensive care unit admission (0·37, 0·07-1·80; p=0·22), and 30-day mortality (0·95, 0·50-1·83; p=1·00). Aggressive periprocedural hydration did not reduce the incidence of post-ERCP pancreatitis in patients with moderate to high risk of developing this complication who routinely received prophylactic rectal NSAIDs. Therefore, the burden of laborious and time-consuming aggressive periprocedural hydration to further reduce the risk of post-ERCP pancreatitis is not justified. Netherlands Organisation for Health Research and Development and Radboud University Medical Center.

S0102 Evaluation of the Effect of Aggressive Hydration on the Incidence of Post-ERCP Pancreatitis

INTRODUCTION: Post ERCP pancreatitis (PEP) is a significant complication with increased morbidity, occasional mortality and increased healthcare costs with an incidence of 9.7% and up to 14.7% in high risk patients. Aggressive hydration during peri-procedure period and for an additional 8 hours post procedure has been shown to reduce the risk of PEP. Our aim was to assess the effect of aggressive hydration for 24 hours post ERCP on the incidence of PEP. METHODS: At our institution, we instituted aggressive hydration therapy (20 ml/Kg bolus of isotonic IVF during procedure followed by 3–5 ml/Kg for 24 hrs) for every hospitalized patient between the ages of 18 to 70 years undergoing ERCP. After 24 hours, IVF were discontinued if patients were able to tolerate oral intake. Patients were monitored for signs of volume overload (lower extremity swelling, pulmonary edema, shortness of breath and rise in BP). We retrospectively reviewed all inpatient ERCPs performed between 10/2017 and 10/2018. Patients with advanced CKD, CHF, COPD with supplemental oxygen, pregnant, or septic were excluded. Patients were high risk for PEP: females <50 years of age, normal serum bilirubin, prior history of pancreatitis, sphincter of Oddi dysfunction, pre-cut sphincterotomy, PD sphincteroplasty, PD cannulation, and PD injection. All high-risk patients received 100 mg rectal indomethacin, unless contraindicated. Stent was placed in PD if cannulated. Average risk patients received rectal indomethacin at the discretion of the endoscopist. PEP was defined based on the Cotton’s criteria. Severity of pancreatitis was defined based on the revised Atlanta criteria. RESULTS: There were a total of 278 inpatient ERCPs between 10/2017 and 10/2018. A total of 164 patients met the inclusion criteria. Fifty-nine patients were considered average risk and 105 were high risk (Table 1). The overall PEP rate in the study cohort was 7.3%. In high risk group overall PEP rate was 9.5% and 3.4% in average risk group. The rate of moderate-severe PEP in the study cohort was 1.8% and in high risk patients was 1.9% (Tables 2 and 3). Four patients developed mild rise in BP while 2 patients developed lower extremity swelling. There were no cases of volume overload necessitating stoppage of IVF in either groups. CONCLUSION: In conclusion, extending aggressive hydration to 24 hours post ERCP helps reduce the incidence of PEP, especially moderate to severe PEP. Further randomized controlled studies are needed to collaborate our study findings.Table 1.: Characteristics of PatientsTable 2.: Characteristics of average risk patients with PEPTable 3.: Characteristics of high risk patients with PEP

Usefulness and Complications of Needle Knife Fistulotomy as a Rescue Procedure in Patients with Pancreaticobiliary Disease.

Needle knife fistulotomy (NKF) is a technique to facilitate pancreatic and biliary duct access during ERCP. The double-guidewire technique (DGT) is also used in cases of difficult cannulation, but it can increase the incidence of post-ERCP-pancreatitis (PEP). This study examined the success and complication rates of NKF after unsuccessful standard cannulation or DGT in patients with pancreaticobiliary disease. The data of 209 patients who received NKF as a rescue procedure between January 2009 and December 2016 were reviewed retrospectively. The cannulation success and complication rates were assessed. The overall cannulation success rate was 90.4%. The success rates of patients who received NKF after standard cannulation or DGT were similar (82.6% [142/172] and 73.0% [27/37], respectively, p=0.179). Furthermore, there was no significant difference in the incidence of procedure-related adverse events between the two groups (10.5% [18/172] and 16.2% [6/37], respectively, p=0.391). Endoscopic retrograde pancreatic drainage (ERPD) insertion decreased the incidence of PEP (0% [0/16] in ERPD and 14.6% [19/130] in non-ERPD, p=0.132) among patients who received PD cannulation. NKF is an effective and safe method that can be considered for rescue management after the initial failure of standard cannulation or DGT. NKF following standard cannulation can be preferred over NKF following DGT because of the higher success rate and the lower rate of pancreatitis, but the difference was not significant. PD stenting in patients at high risk of PEP can be considered to decrease pancreatitis.

ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

1: ESGE recommends routine rectal administration of 100 mg of diclofenac or indomethacin immediately before endoscopic retrograde cholangiopancreatography (ERCP) in all patients without contraindications to nonsteroidal anti-inflammatory drug administration.Strong recommendation, moderate quality evidence. 2: ESGE recommends prophylactic pancreatic stenting in selected patients at high risk for post-ERCP pancreatitis (inadvertent guidewire insertion/opacification of the pancreatic duct, double-guidewire cannulation).Strong recommendation, moderate quality evidence. 3: ESGE suggests against routine endoscopic biliary sphincterotomy before the insertion of a single plastic stent or an uncovered/partially covered self-expandable metal stent for relief of biliary obstruction.Weak recommendation, moderate quality evidence. 4: ESGE recommends against the routine use of antibiotic prophylaxis before ERCP.Strong recommendation, moderate quality evidence. 5: ESGE suggests antibiotic prophylaxis before ERCP in the case of anticipated incomplete biliary drainage, for severely immunocompromised patients, and when performing cholangioscopy.Weak recommendation, moderate quality evidence. 6: ESGE suggests tests of coagulation are not routinely required prior to ERCP for patients who are not on anticoagulants and not jaundiced.Weak recommendation, low quality evidence. 7: ESGE suggests against salvage pancreatic stenting in patients with post-ERCP pancreatitis.Weak recommendation, low quality evidence. 8: ESGE suggests temporary placement of a biliary fully covered self-expandable metal stent for post-sphincterotomy bleeding refractory to standard hemostatic modalities.Weak recommendation, low quality evidence. 9: ESGE suggests to evaluate patients with post-ERCP cholangitis by abdominal ultrasonography or computed tomography (CT) scan and, in the absence of improvement with conservative therapy, to consider repeat ERCP. A bile sample should be collected for microbiological examination during repeat ERCP.Weak recommendation, low quality evidence.

2940 Favorable Rates of Post-ERCP Pancreatitis With Endoscopic Sphincterotomy With Delayed Sphincteroplasty Approach

INTRODUCTION: There are multiple modalities for the management of large bile duct stones during endoscopic retrograde cholangiopancreatography (ERCP). Large bile duct stones, defined as size greater than 15 mm, are a subset of multiple clinical situations associated with difficult bile duct stone extraction. The successful extraction of common bile duct stones typically requires either a sphincterotomy or papillary balloon dilation. Multiple prior studies have shown that endoscopic papillary balloon dilation (EPBD) has less success in stone clearance with more frequent requirement for lithotripsy in addition to carrying a higher risk of post-ERCP pancreatitis. We report the technique of delayed sphincteroplasty to be effective and safe in the management of large bile duct stones. METHODS: A retrospective analysis from 2012 to 2018 was obtained from our endoscopy software of all patients who underwent a two-step ERCP with balloon dilation and analyzed in terms of patient demographics, stone size, success of stone extraction, number or procedures required for duct clearance and procedure-related complications. Patients with bile duct strictures, periampullary malignancy or coagulopathy were excluded. RESULTS: Seventy five patients had ERCP performed with balloon sphincterotomy at least 30 days after initial ERCP. Twenty seven of them were men. Age ranged from 26 to 101 with an average age of 73. 37.3% of the patients were Caucasian, 33.3% African American, 6.6% Asian, 5.3% Hispanic and 17.3% unknown. The average common bile duct size on imaging prior to ERCP was 14.2 mm. The initial ERCP was performed within an average of 4 days of admission. Total bilirubin was 3.9 on average. Most common indication was proven bile duct stone on imaging, 60.8%. 84% of patients had a plastic stent placed during initial ERCP. 13% had more than 5 stones. Balloon was dilated to an average of 14.6 mm. 97% (73/75) had no immediate complications post procedure. Three patients needed additional lithotripsy. CONCLUSION: We present our center's experience with the management of large bile duct stones with the technique using endoscopic sphincterotomy with stent placement for initial drainage and a delayed sphincteroplasty reported decreased rates of post-ERCP pancreatitis and encouraging success rates for stone extraction.

Pancreatic stenting to prevent post-ERCP pancreatitis: a randomized multicenter trial

Background and study aims Acute pancreatitis (AP) is one of the most common gastrointestinal disorders leading to hospitalization and the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP). Besides pharmaco-prophylaxis, pancreatic stenting has been demonstrated to protect from post-ERCP pancreatitis (PEP). However, it remains unclear which patients benefit from pancreatic stenting. We therefore hypothesized that in an unselected population, inadvertent cannulation of the pancreatic duct during first-time ERCP increases risk of PEP and that this risk can be significantly reduced by pancreatic stenting. Patients and methods This study was a multicenter, prospective, randomized controlled trial conducted at four European centers. A total of 167 patients undergoing first-time ERCP were enrolled in this trial. In the case of inadvertent cannulation of the pancreatic duct, patients were randomly assigned to receive either a 5 French plastic pancreatic stent of various length or no routine prophylactic intervention for PEP. Results A total of 167 patients were included in the final analysis. Prophylactic stent insertion significantly reduced the rate of PEP during first-time ERCP (odds ratio 0.43; 95% confidence interval 0.19 – 0.98; P = 0.04). The number needed to treat to prevent one case of PEP by prophylactic stent insertion after inadvertent cannulation of the pancreatic duct was 8.1 for the intention-to-treat population. Conclusion In an unselected patient population, inadvertent cannulation of the pancreatic duct during first-time ERCP is associated with a high risk for PEP. This risk can be significantly reduced by prophylactic pancreatic stenting, which is a safe and feasible procedure.

Primary Needle-Knife Fistulotomy versus Conventional Cannulation Method in High Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicenter Randomized Controlled Trial

Background: Successful biliary cannulation is a prerequisite and important component of endoscopic retrograde cholangiopancreatography (ERCP), but conventional cannulation methods (CCMs) have a post-ERCP pancreatitis (PEP) rate of 14.1% in patients at high risk for PEP. The aims of this study were to evaluate the effectiveness and safety of needle-knife fistulotomy (NKF), compared with a CCM, when used for primary biliary access in patients at high risk for developing PEP. Methods: A total of 207 patients with one or more risk factors for PEP were prospectively enrolled. The patients were randomly allocated to one of two groups according to the primary biliary cannulation technique (NKF or CCM). We compared biliary cannulation success rates, cannulation and procedure times, and the incidence of adverse events, including PEP, between the groups. Findings: The mean number of PEP risk factors was similar between the groups (NKF, 2.2 ± 1.0; CCM, 2.2 ± 0.9). PEP occurred in eight patients in the CCM group and in no patients in the NKF group (9.2% vs. 0%, p < 0.001). The rates of other complications did not differ between the groups. The biliary cannulation success rate was higher in the NKF group than in the CCM group (97.9% vs. 89.7%, p = 0.005). The mean cannulation time and total procedure time were longer in the NKF group than in the CCM group. Interpretation: NKF is an effective and safe procedure to gain primary biliary access in patients at high risk for developing PEP. Trial registration number: ClinicalTrials.gov, NCT02916199. Funding Statement: The authors state: None. Declaration of Interests: The authors state: None. Ethics Approval Statement: The study was approved by the institutional review boards of each institution (Approval number: 3-2017-0092).

Post-ERCP biliary complications in patients with biliary type sphincter of Oddi dysfunction

Sphincter of Oddi dysfunction (SOD) has a high risk of post-ERCP pancreatitis. Cholangitis, colicky pain, and jaundice from cholestasis also occur after ERCP. However, these post-ERCP biliary complications have not been sufficiently evaluated in SOD. Thus, the risk factors and post-ERCP biliary complications in biliary-type SOD were evaluated. From December 1996 to January 2017, 72 patients with suspected biliary-type SOD were selected, and 60 patients who underwent ERCP were included in this study. The incidence of biliary complications compared to control group and factors associated with post-ERCP cholangitis were investigated. More frequent biliary complications, including biliary pain and abnormal liver function, occurred in SOD group than in control group, especially in type I SOD patients. Post-ERCP cholangitis occurred significantly more often with bile duct diameter ≥12 mm (26%, 5/19) than with bile duct diameter <11 mm (2.4%, 1/41; p = 0.016). Age ≥75 years was also a risk factor for post-ERCP cholangitis (p = 0.013). Multivariate analysis confirmed that bile duct diameter ≥12 mm was a significant risk factor for post-ERCP cholangitis. Post-ERCP biliary complications occurred frequently in biliary-type SOD, especially type I. Biliary diameter ≥12 mm was an important risk factor for post-ERCP cholangitis.

Multicenter retrospective and comparative study of 5-minute versus 15-second endoscopic papillary balloon dilation for removal of bile duct stones.

Background and study aims Endoscopic papillary balloon dilation (EPBD) is a method of bile duct stone removal that has a better long-term outcome but a high risk of post-ERCP pancreatitis (PEP). Recent studies have suggested that 5-minute EPBD can reduce the incidence of PEP. This study aimed to examine the safety and effectiveness of longer duration EPBD compared with shorter duration EPBD (5 minutes vs. 15 seconds after disappearance of the waist of a dilation catheter). Patients and methods Patients without a history of endoscopic sphincterotomy or EPBD who underwent EPBD to remove bile duct stones were selected retrospectively from five centers. The incidence of PEP, other early adverse events, and outcomes of EPBD were compared between the groups. A multivariable analysis of risk factors for PEP was performed. Results A total of 607 patients (157 and 450 in the 5-minute and 15-second EPBD groups, respectively) were included. There were no statistically significant differences between the groups in terms of the incidence of PEP (8.3 % and 8.9 % in the 5-minute and 15-second EPBD groups, respectively; P = 0.871) and the incidence of overall early adverse events ( P = 0.999). Although 5-minute EPBD elongated the procedure time (45 vs. 37 minutes, P < 0.001), it increased the rate of complete stone removal during a single session ( P < 0.001) and decreased the use of lithotripsy ( P < 0.001). Conclusions Compared with 15-second EPBD, 5-minute EPBD did not reduce the incidence of PEP.

Revision of biliary sphincterotomy by re-cut, balloon dilation or temporary stenting: comparison of clinical outcome and complication rate (with video).

Background and study aims Revision of endoscopic retrograde cholangiopancreatography (ERCP) may be necessary following previous biliary endoscopic sphincterotomy for recurrent biliary symptoms related to biliary stone recurrence, cholangitis or post-biliary endoscopic sphincterotomy (bEST) papillary stenosis and cholestasis. The aim of this retrospective study was to evaluate the clinical outcome and complication rate associated with re-cut, balloon dilation and biliary metal stenting in revision ERCP. Patients and methods From January 2010 to January 2015, 139 subjects with stigma of a previous sphincterotomy required a revision ERCP (64 Men/75 Women; mean age 71 years; range 32 – 101 years). The most appropriate technique (re-cut, balloon dilation or fully covered self-expandable metal stent [FCSEMS] placement) was tailored according to underlying pathologies and anatomical features. Results Technical success was achieved in all cases (100 %).Clinical success (definitive clearance of common bile duct stones and liver test normalization) was achieved in 127 out of 139 patients (91.4 %) with a mean follow up of 12 months.12 clinical failures occurred: 11 patients required a new ERCP after an average of 9 months meanwhile 1 patient required surgery for definite treatment. The overall complication rate was 9 % (13 /139) with 5 acute complications (intra-procedural) and 8 short-term complications (before 1 month). Group specific overall complication rates were as follow: re-cut 11.5 % (8 bleeds and 3 perforations), balloon dilation 25 % (4 mild PEP [post-ERCP pancreatitis]), FCSEMS 14.3 % (1 moderate PEP), re-cut + balloon dilation and re-cut + FCSEMS 0 %. A statistically significant higher risk of post-ERCP pancreatitis was highlighted in the balloon dilation group meanwhile re-cut was burdened by a higher risk of bleeding and perforation. Conclusions Revision ERCP following previous bEST is a feasible procedure enabling clinical success in most cases. Different approaches are available and must be considered according to underlying pathologies. Re-cut is burdened by a higher risk of perforation and bleeding compared to balloon dilation and SEMS meanwhile balloon dilation is associated to increased risk of PEP.

Role for Pre-ERCP Administration of Rectal Indomethacin in Unselected Patients to Prevent Post ERCP Pancreatitis: A Systematic Review and Meta-analysis

Introduction: Previous studies have reported that peri-procedural administration of rectal indomethacin reduces the risk of pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Based on these studies, the European and Japanese GI societies recommend prophylactic rectal indomethacin for all patients undergoing ERCP. However, recent studies have reported contradictory results. The aim of this study was to perform a systematic review and meta-analysis to estimate the pooled relative risk (RR) of post-ERCP pancreatitis (PEP) in unselected patients who received rectal indomethacin before the ERCP (pre-ERCP) compared to patients who received pre-ERCP rectal placebo. Methods: We conducted a comprehensive search of multiple electronic databases and conference proceedings (from inception through May 1st, 2016) to identify randomized control trials (RCT) investigating the role of pre-ERCP rectal indomethacin in reducing the risk of PEP in unselected patients undergoing ERCP. The databases included Ovid Medline In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, Scopus, and Web of Science. We calculated a pooled estimate of the relative risk (RR) of PEP in patients who received pre-ERCP rectal indomethacin compared to patients who received pre-ERCP rectal placebo. The meta-analysis was performed using random effects model. Results: Five RCTs with a total of 1934 patients were included in the final meta-analysis. There were 996 patients in rectal indomethacin group and 938 patients in rectal placebo group. There were 58 events of PEP in the rectal indomethacin group and 71 events of PEP in rectal placebo group. Pre-ERCP administration of rectal indomethacin reduced the risk of PEP compared to pre-ERCP rectal placebo but the difference was not statistically significant (RR, 0.74, 95% CI, 0.47-1.16; p=0.19) (Figure 1). The heterogeneity between studies was low (I2=41).Figure 1Conclusion: The results of this meta-analysis do not support the routine pre-ERCP administration of rectal indomethacin in unselected patients to prevent PEP. Previous meta-analyses which supported use of NSAIDs had broad inclusion criteria which allowed them to include different NSAID medications, routes of administration, timing of NSAID administration and selected patients at high risk for PEP.

Sa1495 Endoscopic Pancreatic Stent for Prophylaxis in Patients at High-Risk of Post-ERCP Pancreatitis: A Matched Propensity Analysis

Sa1495 Endoscopic Pancreatic Stent for Prophylaxis in Patients at High-Risk of Post-ERCP Pancreatitis: A Matched Propensity Analysis