Occurrence Of post-ERCP Pancreatitis Research Articles

Real-World Evidence comparing Early and Late Pancreatic Stent Placement to Prevent Post-ERCP Pancreatitis

Background: Pancreatic stenting effectively lowers the occurrence of post-ERCP pancreatitis (PEP) and reduces its severity. However, limited research has been conducted to determine the optimal timing for pancreatic stent placement. Our objective was to evaluate whether early pancreatic stent placement (EPSP) is more effective than late pancreatic stent placement (LPSP) in preventing PEP among patients with naive papilla. Methods：We conducted a retrospective cohort study that analyzed 590 patients with difficult biliary cannulation using the pancreatic guidewire technique, who were grouped into EPSP and LPSP. In the EPSP group, a pancreatic stent was placed immediately before/after endoscopic retrograde cholangiography (ERC) or endoscopic sphincterotomy (EST). Conversely, in the LPSP group, a pancreatic stent was placed after partial/all completion of major endoscopic procedures. Results：From Nov. 2017 to May 2023, a total of 385 patients were divided into EPSP and 205 into LPSP. EPSP was associated with a decreased PEP occurrence compared to LPSP (2.9% vs. 7.3%; P=0.012). Similarly, hyperamylasemia was lower in the EPSP group (19.7% vs. 27.8%; P=0.026). Furthermore, sensitivity analysis using multivariable analysis and propensity score–matched (PSM) analysis also validated these findings. Conclusion：Early pancreatic stent placement reduced the incidence of PEP and hyperamylasemia compared to late pancreatic stent placement. Our findings favor pancreatic stenting immediately before/after ERC or EST.

Risk factors for pancreatitis after endoscopic retrograde cholangiopancreatography in children

To investigate the application of endoscopic retrograde cholangiopancreatography (ERCP) in children and the risk factors for post-ERCP pancreatitis (PEP). A retrospective analysis was conducted on the clinical data of 66 children, aged ≤16 years, who underwent ERCP for pancreaticobiliary diseases at the Gastrointestinal Endoscopy Center of the Second Affiliated Hospital of Kunming Medical University from September 2013 to September 2023. The incidence rate of PEP and the risk factors for the development of PEP were analyzed. A total of 78 ERCP procedures were performed on 66 children, with 5 diagnostic ERCPs, 69 therapeutic ERCPs, and 4 failed procedures. The success rate of ERCP operations was 95% (74/78). There were 17 cases of PEP in total, with an incidence rate of 22%. In the PEP group, the proportion of children with normal preoperative bilirubin and the proportion of guidewire insertion into the pancreatic duct during surgery were higher than in the non-PEP group (P<0.05). The multivariate logistic regression analysis showed that guidewire insertion into the pancreatic duct was an independent risk factor for PEP (P<0.05). With the increasing application of ERCP in children with pancreaticobiliary diseases, it is important to select an appropriate intubation technique during surgery to avoid blindly entering the guidewire into the pancreatic duct and reduce the occurrence of PEP.

Aggressive hydration with lactated Ringer’s solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial

IntroductionEndoscopic retrograde cholangiopancreatography (ERCP) plays an indispensable role in treating pancreato-biliary diseases but carries a risk of post-ERCP pancreatitis (PEP). Despite advances in the prevention strategies, prevention of PEP remains...

Nafamostat Reduces the Incidence of post-ERCP Pancreatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). As the management of pancreatitis is limited, clinical approaches focus on the prevention of post-ERCP pancreatitis (PEP). In theory, the serine protease inhibitor nafamostat can reduce circulating inflammatory mediators in pancreatitis. We aimed to investigate the effect of nafamostat in the prevention of PEP in this systematic review and meta-analysis. The protocol for this review was registered in PROSPERO (CRD42022367988). We systematically searched 5 databases without any filters on September 26, 2022. The eligible population was adult patients undergoing ERCP. We compared the PEP preventive effect of nafamostat to placebo. The main outcome was the occurrence of PEP. We calculated the pooled odds ratios (ORs), mean differences, and corresponding 95% confidence intervals (95% CIs) and multilevel model. The risk of bias was assessed using the Rob2 tool. Seven randomized controlled trials involving 2,962 patients were eligible for inclusion. Nafamostat reduced the overall incidence rate of PEP (20 mg, OR: 0.50, 95% CI: 0.30-0.82 and 50 mg, OR: 0.48, 95% CI: 0.24-0.96). However, the occurrence of mild PEP was significantly reduced only in the subgroup receiving 20 mg nafamostat (OR, 0.49, 95% CI: 0.31-0.77). Overall, nafamostat therapy reduced moderate PEP in high-risk patients (OR: 0.18, 95% CI: 0.0.4-0.84) and mild PEP in low-risk patients (OR: 0.32, 95% CI: 0.17-0.61). Nafamostat is an effective therapy in the prevention of mild post-ERCP pancreatitis. Further research is required to determine the cost-effectiveness of this therapy.

Endoscopic retrograde cholangiopancreatography outcomes in inflammatory bowel disease patients: a 12-year analysis of a national database

Despite inflammatory bowel disease's (IBD) association with hepatobiliary disorders and the use of endoscopic retrograde cholangiopancreatography (ERCP) for both diagnostic and therapeutic evaluation of these diseases, it remains a poorly studied area within the literature. The purpose of this study is to examine the effect of IBD on the occurrence of adverse events (AE) pertaining to ERCP.This project utilized the National Inpatient Sample (NIS) database, the largest inpatient database in the USA. All patients 18 years or older with and without IBD undergoing ERCP were identified from 2008 to 2019. Post-ERCP AEs were analyzed using multivariate logistic or linear regression controlling for age, race, and existing comorbidities using the Charlson comorbidity index (CCI).There was no difference in post-ERCP pancreatitis (PEP) or mortality. IBD patients were also found to have a lower risk of bleeding and decreased length of stay (LOS) despite adjustment for comorbidities. They also underwent less sphincterotomies when compared to the non-IBD cohort. Subgroup analysis between ulcerative colitis (UC) and Crohn's disease (CD) did not find any significant differences in outcomes.To our knowledge, this is the largest study to date evaluating ERCP outcomes in IBD patients. After adjustment of co-variates, there was no difference in the occurrence of PEP, infections, and perforation. IBD patients were less likely to experience post-ERCP bleeding and mortality and had shorter LOS which may be due to the decreased frequency of sphincterotomy in this population.

Risk factors of pancreatitis after endoscopic retrograde cholangiopancreatography in patients with biliary tract diseases

BackgroundTo investigate the risk factors of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in patients with biliary tract diseases.MethodsWe retrospectively analyzed the clinical data of 480 patients who underwent ERCP for biliary tract diseases at the Affiliated Zhongshan Hospital of Dalian University from October 2011 to October 2016. The patients were divided into a study group (n = 75, with PEP) and a control group (n = 405, without PEP) based on whether they developed post-ERCP pancreatitis (PEP), and their clinical baseline data and intraoperative conditions were retrieved and compared. Then, factors associated with PEP were analyzed using logistic regression model, based on which a nomogram prediction model was constructed. The receiver operating characteristic (ROC) curve and calibration curve were used to evaluate the performance of the prediction model.ResultsSignificant differences in age, sex, history of pancreatitis, history of choledocholithiasis, pancreatic duct imaging, pancreatic sphincterotomy, difficult cannulation, multiple cannulation attempts and juxtapapillary duodenal diverticula were observed between the two groups. Multivariate logistic regression analysis showed that age less than 60 years (OR, 0.477; 95% CI, 0.26–0.855), female sex (OR, 2.162; 95% CI, 1.220–3.831), history of pancreatitis (OR, 2.567; 95% CI, 1.218–5.410), history of choledocholithiasis (OR, 2.062; 95% CI, 1.162–3.658), pancreatic sphincterotomy (OR, 2.387; 95% CI, 1.298–4.390), pancreatic duct imaging (OR, 4.429; 95% CI, 1.481–13.242), multiple cannulation attempts (OR, 2.327; 95% CI, 1.205–4.493), difficult cannulation (OR, 2.421; 95% CI, 1.143–5.128), and JPD (OR, 2.002; 95% CI, 1.125–3.564) were independent risk factors for PEP. The nomogram for predicting the occurrence of PEP demonstrated an area under the ROC curve (AUC) of 0.787, and the calibration curves of the model showed good consistency between the predicted and actual probability of PEP.ConclusionOur results showed that age less than 60 years, female sex, history of pancreatitis, history of choledocholithiasis, pancreatic sphincterotomy, pancreatic duct imaging, multiple cannulation attempts, difficult cannulation and juxtapapillary duodenal diverticula were independent risk factors for PEP. In addition, the established nomogram demonstrated promising clinical efficacy in predicting PEP risk in patients who underwent ERCP for biliary tract diseases.

Prevention of post-ERCP pancreatitis: current strategies and novel perspectives.

Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic procedure that might lead to severe adverse events. Post-ERCP pancreatitis (PEP) is the most common post-procedural complication, which is related to significant mortality and increasing healthcare costs. Up to now, the prevalent approach to prevent PEP consisted of employing pharmacological and technical expedients that have been shown to improve post-ERCP outcomes, such as the administration of rectal nonsteroidal anti-inflammatory drugs, aggressive intravenous hydration, and the placement of a pancreatic stent. However, it has been reported that PEP originates from a more complex interaction of procedural and patient-related factors. Appropriate ERCP training has a pivotal role in PEP prevention strategy, and it is not a chance that a low PEP rate is universally considered one of the most relevant indicators of proficiency in ERCP. Scant data on the acquisition of skills during the ERCP training are currently available, although some efforts have been recently done to shorten the learning curve by way of simulation-based training and demonstrate competency by meeting technical requirements as well as adopting skill evaluation scales. Besides, the identification of adequate indications for ERCP and accurate pre-procedural risk stratification of patients might help to reduce PEP occurrence regardless of the endoscopist's technical abilities, and generally preserve safety in ERCP. This review aims at delineating current preventive strategies and highlighting novel perspectives for a safer ERCP focusing on the prevention of PEP.

Impact of laparoscopic cholecystectomy on the complexity of endoscopic retrograde cholangiopancreatography.

A scarce number of researches discussed the impact of cholecystectomies on the anatomy of common bile duct (CBD) and intern if this will affect the difficulty of endoscopic retrograde cholangiopancreatography (ERCP). The objective of present study was to assess the impact of complicated cholecystectomy on the complexity and safety of the ERCP procedure. A total of 100 patients were enrolled after meeting the following inclusion criteria - study group (group A): 50 patients with previous history of complicated laparoscopic cholecystectomy and control group (group B): 50 patients with previous noncomplicated laparoscopic cholecystectomy. ERCP was performed and complexity was judged by a number of cannulation attempts, ERCP time, pancreatic cannulation and post-ERCP pancreatitis. The study revealed prolonged ERCP procedure duration in noncomplicated cholecystectomy (24.2 ± 8.5 min) and it was significantly more prolonged in complicated cholecystectomy (39.6 ± 10.7 min; P = 0.03). The trials of cannulation attempts were significantly higher in the study group with complicated cholecystectomy (P = 0.009). Pancreatic duct cannulation was frequently higher in the complicated cholecystectomy group (P = 0.03). Difficult or failed stone extraction was significantly prevalent in the complicated cholecystectomy group and the occurrence of post-ERCP pancreatitis (PEP) was significantly higher than the control group. ERCP after complicated laparoscopic cholecystectomy is more complex with increased duration liability of complications.

Three-hour post-ERCP amylase level: a useful indicator for early prediction of post-ERCP pancreatitis

BackgroundTo evaluate the value of the 3-h post-ERCP serum amylase level for early prediction of post-ERCP pancreatitis (PEP).MethodA study of 206 patients performed ERCP (Encoscopic Retrograde Cholangio-Pancreatography) at a single centre was done from Jan. 2011 to Nov. 2016. The serum amylase or lipase level was measured at 3 h after ERCP. The patients with PEP were recorded. ROC curves were used to statistically analyze the data: The enrolled patients were divided into two groups according to gender, then we analyzed the data respectively. We comprehensively evaluated the predictive value of PEP by 3-h post-ERCP serum amylase level based on the results above.ResultsTwo hundred six patients (92 males, 114 females) were enrolled. PEP occurred in 21 patients (10.19%) among them. The median time to discharge was 7 days (min = 1d, max = 13d) after the procedure. In the 206 patients, the 3-h post-ERCP pancreatic amylase level was used as the test variable, and the PEP occurrence as the state variable to plot the ROC curve. The area under the curve (AUC) was 0.816, and was statistically significant (P < 0.001). The standard error (SE) was 0.0507, the 95% confidence interval (CI) was 0.756–0.866, and the optimal cut-off value was 351 U/L (sensitivity 76.19%, specificity 83.24%, positive likelihood ratio 4.55, negative likelihood ratio 0.29, Youden index 59.43%). Of the 206 patients, there were 83 patients with both 3-h post-ERCP amylase level and lipase level detected, and the ROC curves were plotted for both serum amylase and lipase respectively. The ROC curve matched-pair testing was carried out: The areas under the ROC curves were statistically significant. (P < 0.001) The area under the ROC curve for the 3-h post-ERCP lipase was 0.778, the 95% confidence interval was 0.673–0.862, and optimal cut-off value was 1834 U/L. The area under the ROC curve for the 3-h post-ERCP serum amylase was 0.780, and the 95% confidence interval was 0.676–0.864. The optimal cut-off is 380 U/L, and there was no statistically significant difference between the two for diagnostic accuracy. According to gender, 206 patients were divided into 2 groups, and the ROC curves were drawn respectively. Based on statistical analysis, there was no statistically significant difference in the diagnostic accuracy of the two groups. In the male group, 436 U/L serum amylase provided the greatest diagnostic accuracy with sensitivity (SE) of 70.5%, specificity (SP) of 89.2%, positive predictive value (PPV) 87.5%, and negative predictive value (NPV) 78.1%. Whereas, in the female group, 357 U/L serum amylase provided the greatest diagnostic accuracy with sensitivity of 76.9%, specificity of 81.2%, positive predictive value of 80.4%, negative predictive value of 77.9%.Conclusions1. The 3-h post-ERCP serum amylase level is a useful measurement for predicting post-ERCP pancreatitis. 2. There was no significant difference between serum amylase and lipase 3-h post-ERCP for predicting PEP. 3. There was no statistically significant difference between male and female using the 3-h post-ERCP serum amylase level to predict PEP. For female, the optimal cut-off value was 357 U/L, whereas male 436 U/L .

Inutility of endoscopic sphincterotomy to prevent pancreatitis after biliary metal stent placement in the patients without pancreatic duct obstruction

Background: The incidence of post-ERCP pancreatitis (PEP) has been reported to be significantly higher in patients without main pancreatic duct (MPD) obstruction who undergo transpapillary biliary metal stent (MS) placement than in those with ordinary ERCP setting.Objective: To evaluate the benefit of endoscopic sphincterotomy (ES) prior to MS placement in preventing PEP in patients with distal malignant biliary obstruction (MBO) without MPD obstruction.Materials and methods: In total, 160 patients who underwent initial MS placement for MBO were enrolled. Eighty-two patients underwent ES immediately prior to MS placement, whereas 78 underwent MS placement without ES. An inverse probability of treatment weighting method was adopted to adjust the differences of the patients’ characteristics. The primary outcome was the incidence of PEP. The secondary outcomes included the incidence of other adverse events (bleeding, cholangitis, perforation and stent dislocation) and time to recurrent biliary obstruction.Results: The incidence of PEP was 26.8% in the ES and 23.1% in the non-ES (unadjusted odds ratio [OR] [95%CI]: 1.22, [0.60–2.51], adjusted OR [95%CI]: 1.23, [0.53–2.81], p = .63). Logistic-regression analysis revealed no factors that could be attributed to the occurrence of PEP. The incidence of other adverse events was not different between the groups. The median time to recurrent biliary obstruction was 131 (2–465) days and 200 (4–864) days in the ES and non-ES, respectively (p = .215).Conclusions: ES prior to MS placement for patients with distal MBO without MPD obstruction does not reduce the incidence of PEP.

Low-dose rectal diclofenac does not prevent post-ERCP pancreatitis in low- or high-risk patients.

The most common adverse event following an endoscopic retrograde cholangiopancreatography (ERCP) procedure is post-ERCP pancreatitis (PEP). Rectal nonsteroidal anti-inflammatory drug (NSAID) administration has shown promise to reduce the risk of PEP in high-risk patients. However, in contrast to high-risk patients, the role of NSAID administration in patients with low risk remains controversial. We performed a prospective, single-center, single-blinded, two-arm parallel group, randomized controlled trial to clarify the efficacy of low dose (50mg) rectal NSAID administration for preventing PEP in at-risk patients. Patients scheduled to undergo ERCP were randomized into two groups, those with and without rectal administration of diclofenac. Patients in the diclofenac group received 50mg of rectal diclofenac 30min before undergoing ERCP. The primary endpoint was rate of PEP. A total of 303 were randomized into the study groups. Four patients declined participation following randomization, and another two were withdrawn. As a result, a total of 147 patients were assigned to the diclofenac group and 150 to the control group. The baseline and procedural characteristics were similar in both groups. The primary endpoint of PEP occurrence was seen in 13 of 297 patients (4.4%), including eight (5.4%) in the diclofenac group and five (3.3%) in the control group (P=0.286). Additionally, those results were not significantly different when patients were classified as low or high risk. Prophylactic low-dose rectal diclofenac did not reduce the incidence of PEP following ERCP in patients classified as low or high risk.

Does melatonin addition to indomethacin decrease post endoscopic retrograde cholangiopancreatography pancreatitis? A randomized double-blind controlled trial

Post-ERCP pancreatitis (PEP) is the most prevalent complication of endoscopic retrograde cholangiopancreatography (ERCP). Melatonin has been mentioned as a protective factor against acute pancreatitis. The present study was conducted to determine whether melatonin addition to indomethacin reduces the rate of PEP occurrence. A double-blind randomized clinical trial was conducted on 411 patients undergoing ERCP. Baseline blood samples were collected, and the patients were given melatonin 3 mg tablets plus indomethacin suppository 100 mg or placebo plus indomethacin suppository 100 mg, 1 h before ERCP. The occurrence of PEP was the primary outcome. The concentrations of amylase and lipase were also measured 24 h after ERCP. Demographic characteristics of patients, characteristics of ERCP procedures, and baseline levels of amylase and lipase were found to be similar in both groups. The overall rate of PEP was equal to 9.5% in intention-to-treat (ITT) and 11.4% in per-protocol (PP) analyses. There was a significant difference in the rate of PEP between the melatonin and placebo groups (8.7% vs. 11.4% in ITT and 9.3% vs. 13.6% in PP, respectively). In addition, after 24 h, amylase and lipase levels were lower in the melatonin group than in the placebo group (P = 0.041 and 0.032, respectively). The results of the present study showed that, administration of melatonin 3 mg tablets plus indomethacin suppository 100 mg 1 h before ERCP could decrease the PEP rate and amylase and lipase levels compared to administration of indomethacin suppository 100 mg alone.

Combination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography

Acute pancreatitis is a major adverse event of endoscopic retrograde cholangiopancreatography (ERCP). Rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs) decreases the incidence of post-ERCP pancreatitis (PEP). Little is known about the combined effects of sublingual nitrate and NSAIDs. We performed a randomized trial to assess whether the combination of NSAIDs and sublingual nitrate is more effective than NSAIDs alone in preventing PEP. In a prospective superiority trial, eligible patients underwent ERCP at 12 endoscopic units in Japan, from March 2015 through May 2018. Patients were randomly assigned to groups given diclofenac suppositories (50 mg) within 15 minutes after the endoscopic procedure alone (diclofenac-alone group, n= 442) or in combination with sublingual isosorbide dinitrate (5 mg) 5 minutes before the endoscopic procedure (combination group, n= 444). The primary endpoint was the occurrence of PEP. PEP developed in 25 patients in the combination group (5.6%), and in 42 patients in the diclofenac-alone group (9.5%) (relative risk 0.59; 95% confidence interval 0.37-0.95; P= .03). Moderate to severe pancreatitis developed in 4 patients (0.9%) in the combination group, and 10 patients (2.3%) in the diclofenac-alone group (relative risk 0.12; 95% confidence interval 0.13-1.26; P= .12). There was no serious adverse event related to the additional administration of sublingual nitrate. In a randomized controlled trial, we found that prophylaxis with rectal diclofenac and sublingual nitrate significantly reduces the overall incidence of PEP compared with diclofenac suppository alone. ClinicalTrials.gov, no: UMIN 000016274.

Risk Factors for Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis in the Indomethacin Era – A Prospective Study

Background and Aims: Although endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure used to treat conditions affecting the biliopancreatic system, it can lead to several complications. Post-ERCP pancreatitis (PEP) is the most frequent one, with an incidence ranging from 3 to 14%. Our aim was to assess the potential risk factors associated with PEP occurrence in patients undergoing ERCP with indomethacin prophylaxis. Methods: Prospective, single-center, real-world observational study (January to December 2015) with inclusion of patients submitted to ERCP, where relevant patient-related and procedure-related data had been collected. Patients had to have been admitted for a minimum of 24 h in order to establish the presence of early complications. All patients were submitted to PEP prophylaxis with 1 or 2 methods: rectal indomethacin and pancreatic duct (PD) stenting. Results: A total of 188 patients who had undergone ERCP were included (52.7% women; mean age 69.2 ± 16.0 years) and PEP was diagnosed in 13 (6.9%). PEP prophylaxis consisted of indomethacin in all cases (100%) and PD stenting in 7.4%. The pancreatitis was mild in 11 patients (84.6%) and severe in the other 2. One of them died (0.5%). None of the patient-related risk factors were associated with changes in PEP probability. Of all patients, 33.0% had 2 or more procedure-related risk factors. A higher number of synchronous procedure-related risk factors showed a statistically significant correlation with PEP occurrence, p = 0.040. Conclusions: The 6.9% PEP rate is considered acceptable since 33.0% patients had a medium-high risk for PEP due to challenging biliary cannulation. The total number of procedure-related risk factors seems to play a critical role in the development of PEP despite indomethacin prophylaxis.

Analysis of risk factors and prevention strategies of post-ERCP pancreatitis.

To analyze the relevant risk factors and preventive measures for post-endoscopic retrograde cholangiopancreatography (post-ERCP) pancreatitis (PEP) so as to improve the diagnosis and treatment levels of ERCP, thus reducing the prevalence rate of PEP. The clinical data of 278 patients receiving ERCP from January 2014 to December 2016 were retrospectively analyzed. First, the univariate analysis was conducted for the factors such as gender, age, diameter of common bile duct, whether development occurred in the pancreatic duct and other factors. Then, the multivariate logistic regression analysis was performed for factors showing statistical significance in the univariate analysis so as to analyze the independent risk factors for PEP. The success rate of ERCP included in the study was 97.12%. The prevalence rate of PEP was 8.27%. Univariate analysis results showed that the prevalence rate of PEP in the group of patients younger than 60 years old was higher than that in the group of patients older than 60 years old (14.14% vs. 5.03%, p = 0.016); the prevalence rate of PEP in the group of patients with intubation difficulty was higher than that in the group of patients without intubation difficulty (19.61% vs. 5.73%, p = 0.004); the prevalence rate of PEP in the group of patients with operation time more than 60 min was higher than that in the group of patients with operation time less than 60 min (18.60% vs. 6.38%, p = 0.034); the prevalence rate of PEP in the group of patients with the pancreatic duct development was higher than that in the group of patients without the pancreatic duct development (50% vs. 6.72%, p < 0.001); the prevalence rate of PEP in the group of patients placed with nasobiliary drainage catheters was not higher than that in the group of patients not placed with nasobiliary drainage catheters (18.00% vs. 2.81%, p < 0.001). The above five relevant factors were included in the logistic regression equation for the multivariate analysis, which showed that the age less than 60 years old (p = 0.002) and the pancreatic duct development (p = 0.004) were independent risk factors for PEP, and nasobiliary drainage (p = 0.003) was a protective factor for PEP. The occurrence of PEP is associated with the age less than 60 years old, the pancreatic duct development, intubation difficulty and overlong operation time. Among them, the pancreatic duct development and the age less than 60 years old are independent risk factors for PEP. Placing nasobiliary drainage catheters after operation, avoiding the pancreatic duct development, improving the success rate of intubation, reducing ERCP operation time and other methods, can effectively reduce the occurrence of PEP.

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitrate as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography(ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitrate might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitrate for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitrate can prevent PEP.

Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial

Rectal indometacin decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, the population most at risk and the optimal timing of administration require further investigation. We aimed to assess whether pre-procedural administration of rectal indometacin in all patients is more effective than post-procedural use in only high-risk patients to prevent post-ERCP pancreatitis. We did a multicentre, single-blinded, randomised controlled trial at six centres in China. Eligible patients with native papilla undergoing ERCP were randomly assigned in a 1:1 ratio (with a computer-generated list) to universal pre-procedural indometacin or post-procedural indometacin in only high-risk patients, with stratification by trial centres and block size of ten. In the universal indometacin group, all patients received a single dose (100 mg) of rectal indometacin within 30 min before ERCP. In the risk-stratified, post-procedural indometacin group, only patients at predicted high risk received rectal indometacin, immediately after ERCP. Investigators, but not patients, were masked to group allocation. The primary outcome was overall ocurrence of post-ERCP pancreatitis. The analysis followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT02002650. Between Dec 15, 2013, and Sept 21, 2015, 2600 patients were randomly assigned to universal, pre-procedural indometacin (n=1297) or risk-stratified, post-procedural indometacin (n=1303). Overall, post-ERCP pancreatitis occurred in 47 (4%) of 1297 patients assigned to universal indometacin and 100 (8%) of 1303 patients assigned to risk-stratified indometacin (relative risk 0·47; 95% CI 0·34-0·66; p<0·0001). Post-ERCP pancreatitis occurred in 18 (6%) of 305 high-risk patients in the universal group and 35 (12%) of 281 high-risk patients in the risk-stratified group (p=0·0057). Post-ERCP pancreatitis was also less frequent in average-risk patients in the universal group (3% [29/992]), in which they received indometacin, than in the risk-stratified group (6% [65/1022]), in which they did not receive the drug (p=0·0003). Other than pancreatitis, adverse events occurred in 41 (3%; two severe) patients in the universal indometacin group and 48 (4%; one severe) patients in the risk-stratified group. The most common adverse events were biliary infection (22 [2%] patients vs 33 [3%] patients) and gastrointestinal bleeding (13 [1%] vs ten [1%]). Compared with a risk-stratified, post-procedural strategy, pre-procedural administration of rectal indometacin in unselected patients reduced the overall occurrence of post-ERCP pancreatitis without increasing risk of bleeding. Our results favour the routine use of rectal indometacin in patients without contraindications before ERCP. National Key Technology R&D Program, National Natural Science Foundation of China.

Pancreatic Stenting Reduces Post-ERCP Pancreatitis and Biliary Sepsis in High-Risk Patients: A Randomized, Controlled Study.

Background. Endoscopic retrograde cholangiopancreatography (ERCP) is an established treatment modality for bile duct disorders, but patients have a risk of post-ERCP pancreatitis (PEP) and biliary sepsis. Aim. To evaluate the effectiveness and safety of pancreatic stent for prophylaxis of PEP and biliary sepsis in high-risk patients with complicating common bile duct (CBD) disorders. Methods. Two hundred and six patients with complicating confirmed or suspected CBD disorders were randomly assigned to receive ERCP with pancreatic stenting (experimental group) or without stenting (control group). Primary outcome measure was frequency of PEP, and secondary outcome measures included operative time, blood loss, postoperative recovery times, and other ERCP-associated morbidities. Results. Baseline age, sex, CBD etiology, concomitant medical/surgical conditions, cannulation difficulty, and ERCP success were comparable between the two groups (all P > 0.05). Compared to the control group, the experimental group had a significantly lower frequency of PEP (7.7% versus 17.7%, P < 0.05) and positive bile microbial culture (40.4% versus 62.7%, P < 0.05). However, the two groups were similar in operative time, blood loss, postoperative recovery times, and other ERCP-associated morbidities (all P > 0.05). Conclusions. Pancreatic stenting can reduce the occurrence of PEP and biliary sepsis in high-risk patients with complicating CBD disorders but does not increase other ERCP-associated morbidities. This trial is registered with the Chinese Clinical Trial Registry (registration identifier ChiCTR-OCH-14005134).

25 mg versus 50 mg dose of rectal diclofenac for prevention of post-ERCP pancreatitis in Japanese patients: a retrospective study

ObjectivesThe aim of the present study was to assess the appropriate administration dose of non-steroidal anti-inflammation drugs to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). Importantly, the 100 mg dose...

Balloon dilation itself may not be a major determinant of post-endoscopic retrograde cholangiopancreatography pancreatitis.

Endoscopic retrograde cholangiopancreatography (ERCP) is the essential first modality for common bile duct (CBD) stone therapy. The conventional endoscopic treatment for CBD stones is stone removal after endoscopic sphincterotomy (EST). Stone removal after papillary stretching using balloon dilation instead of the conventional method has been widely adopted. There are many reports regarding endoscopic papillary balloon dilation (EPBD) utilizing a small balloon (< 10 mm) instead of EST for the removal of small CBD stones. In contrast, two cases of mortality due to post-ERCP pancreatitis (PEP) were reported after an EPBD clinical trial in the Western world, and the psychological barrier caused by these incidences hinders the use of this technique in Western countries. Endoscopic papillar large balloon dilation (EPLBD), which is used to treat large CBD stones, was not widely adopted when first introduced due to concerns about perforation and severe pancreatitis from the use of a large balloon (12-20 mm). However, as experience with this procedure accumulates, the occurrence of PEP with EPLBD is confirmed to be much lower than with EPBD. This report reviews whether EPBD and EPLBD, two procedures that use balloon dilation but differ in terms of indications and concept, contribute to the occurrence of PEP.