Dataset Information

Endoscopic sphincterotoMy for delayIng choLecystectomy in mild acute biliarY pancreatitis (EMILY study): protocol of a multicentre randomised clinical trial.

ABSTRACT:

Introduction

According to the literature, early cholecystectomy is necessary to avoid complications related to gallstones after an initial episode of acute biliary pancreatitis (ABP). A randomised, controlled multicentre trial (the PONCHO trial) revealed that in the case of gallstone-induced pancreatitis, early cholecystectomy was safe in patients with mild gallstone pancreatitis and reduced the risk of recurrent gallstone-related complications, as compared with interval cholecystectomy. We hypothesise that carrying out a sphincterotomy (ES) allows us to delay cholecystectomy, thus making it logistically easier to perform and potentially increasing the efficacy and safety of the procedure.

Methods/design

EMILY is a prospective, randomised, controlled multicentre trial. All patients with mild ABP, who underwent ES during the index admission or in the medical history will be informed to take part in EMILY study. The patients will be randomised into two groups: (1) early cholecystectomy (within 6 days after discharge) and (2) patients with delayed (interval) cholecystectomy (between 45 and 60 days after discharge). During a 12-month period, 93 patients will be enrolled from participating clinics. The primary endpoint is a composite endpoint of mortality and recurrent acute biliary events (that is, recurrent ABP, acute cholecystitis, uncomplicated biliary colic and cholangitis). The secondary endpoints are organ failure, biliary leakage, technical difficulty of the cholecystectomy, surgical and other complications.

Ethics and dissemination

The trial has been registered internationally ISRCTN 10667869, and approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (EKU/2018/12176-5).

Trial registration number

ISCRTN 10667869; Pre-results.

SUBMITTER: Kucserik LP

PROVIDER: S-EPMC6629406 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

Endoscopic sphincterotoMy for delayIng choLecystectomy in mild acute biliarY pancreatitis (EMILY study): protocol of a multicentre randomised clinical trial.

Kucserik Levente Pál LP Márta Katalin K Vincze Áron Á Lázár György G Czakó László L Szentkereszty Zsolt Z Papp Mária M Palatka Károly K Izbéki Ferenc F Altorjay Áron Á Török Imola I Barbu Sorin S Tantau Marcel M Vereczkei András A Bogár Lajos L Dénes Márton M Németh Imola I Szentesi Andrea A Zádori Noémi N Antal Judit J Lerch Markus M MM Neoptolemos John J Sahin-Tóth Miklós M Petersen Ole H OH Kelemen Dezső D Hegyi Péter P

BMJ open 20190709 7

<h4>Introduction</h4>According to the literature, early cholecystectomy is necessary to avoid complications related to gallstones after an initial episode of acute biliary pancreatitis (ABP). A randomised, controlled multicentre trial (the PONCHO trial) revealed that in the case of gallstone-induced pancreatitis, early cholecystectomy was safe in patients with mild gallstone pancreatitis and reduced the risk of recurrent gallstone-related complications, as compared with interval cholecystectomy. ...[more]

PMID: 31289058

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Project description:BackgroundEndoscopic sphincterotomy (ES) is the standard treatment for common bile duct stones. The reported findings regarding complications, such as biliary pancreatitis and cholangitis, differ between cholecystectomy after ES. The purpose of this study is to compare cholecystectomy outcomes after endoscopic treatment of common bile duct stones whether or not the incidence of recurrent pancreatitis and cholangitis is reduced, especially in high-risk patients.MethodsWe analyzed 8 studies, including 7 randomized controlled trials retrieved from the PubMed (1990-2019), Embase (1990-2019), and Cochrane (1990-2019) databases for trials comparing the two strategies for treatment of gallstones after ES. A related study on gallbladder removal after ES was acquired, followed by analysis of each group using RevMan. Risk ratios (RRs) were calculated for categorical variables and differences in means were calculated for continuous variables.ResultsWe retrieved a total of 8 studies, including seven randomized controlled trials and one retrospective study. A total of 12,717 patients were included in the study (4922 in the early cholecystectomy group and 7795 in the gallbladder in situ group). During the follow-up period, 41 patients had pancreatitis after ES in the cholecystectomy group and 177 patients in the wait-and-see group. The incidence of pancreatitis in the cholecystectomy group was significantly reduced (RR, 0.38; 95% CI, 0.27-0.53; P < 0.00001; I2 = 0%). The incidence of cholangitis and jaundice in the cholecystectomy group was also less than the preserved gallbladder group (RR, 0.31; 95% CI, 0.26-0.38; P < 0.00001; I2 = 0%). There was no significant difference in mortality between the two groups (RR, 0.73; 95% CI, 0.52-1.02; P = 0.07; I2 = 14%). There was a significant difference in cholecystitis and biliary colic (RR, 0.28; 95% CI, 0.24-0.32; P < 0.00001; I2 = 17%).ConclusionEarly cholecystectomy after removal of common bile duct stones can effectively reduce biliary complications. This is still true for high-risk patients and has no significant effect on the mortality of patients. Laparoscopic cholecystectomy is recommended after ES.

Project description:ImportanceConsidering the lack of equipoise regarding the timing of cholecystectomy in patients with moderately severe and severe acute biliary pancreatitis (ABP), it is critical to assess this issue.ObjectiveTo assess the outcomes of early cholecystectomy (EC) in patients with moderately severe and severe ABP.Design, settings, and participantsThis cohort study retrospectively analyzed real-life data from the MANCTRA-1 (Compliance With Evidence-Based Clinical Guidelines in the Management of Acute Biliary Pancreatitis) data set, assessing 5304 consecutive patients hospitalized between January 1, 2019, and December 31, 2020, for ABP from 42 countries. A total of 3696 patients who were hospitalized for ABP and underwent cholecystectomy were included in the analysis; of these, 1202 underwent EC, defined as a cholecystectomy performed within 14 days of admission. Univariable and multivariable logistic regression models were used to identify prognostic factors of mortality and morbidity. Data analysis was performed from January to February 2023.Main outcomesMortality and morbidity after EC.ResultsOf the 3696 patients (mean [SD] age, 58.5 [17.8] years; 1907 [51.5%] female) included in the analysis, 1202 (32.5%) underwent EC and 2494 (67.5%) underwent delayed cholecystectomy (DC). Overall, EC presented an increased risk of postoperative mortality (1.4% vs 0.1%, P < .001) and morbidity (7.7% vs 3.7%, P < .001) compared with DC. On the multivariable analysis, moderately severe and severe ABP were associated with increased mortality (odds ratio [OR], 361.46; 95% CI, 2.28-57 212.31; P = .02) and morbidity (OR, 2.64; 95% CI, 1.35-5.19; P = .005). In patients with moderately severe and severe ABP (n = 108), EC was associated with an increased risk of mortality (16 [15.6%] vs 0 [0%], P < .001), morbidity (30 [30.3%] vs 57 [5.5%], P < .001), bile leakage (2 [2.4%] vs 4 [0.4%], P = .02), and infections (12 [14.6%] vs 4 [0.4%], P < .001) compared with patients with mild ABP who underwent EC. In patients with moderately severe and severe ABP (n = 108), EC was associated with higher mortality (16 [15.6%] vs 2 [1.2%], P < .001), morbidity (30 [30.3%] vs 17 [10.3%], P < .001), and infections (12 [14.6%] vs 2 [1.3%], P < .001) compared with patients with moderately severe and severe ABP who underwent DC. On the multivariable analysis, the patient's age (OR, 1.12; 95% CI, 1.02-1.36; P = .03) and American Society of Anesthesiologists score (OR, 5.91; 95% CI, 1.06-32.78; P = .04) were associated with mortality; severe complications of ABP were associated with increased mortality (OR, 50.04; 95% CI, 2.37-1058.01; P = .01) and morbidity (OR, 33.64; 95% CI, 3.19-354.73; P = .003).Conclusions and relevanceThis cohort study's findings suggest that EC should be considered carefully in patients with moderately severe and severe ABP, as it was associated with increased postoperative mortality and morbidity. However, older and more fragile patients manifesting severe complications related to ABP should most likely not be considered for EC.

Dataset Information

Endoscopic sphincterotoMy for delayIng choLecystectomy in mild acute biliarY pancreatitis (EMILY study): protocol of a multicentre randomised clinical trial.

Introduction

Methods/design

Ethics and dissemination

Trial registration number

Publications

Endoscopic sphincterotoMy for delayIng choLecystectomy in mild acute biliarY pancreatitis (EMILY study): protocol of a multicentre randomised clinical trial.

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