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Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial.

ABSTRACT: IMPORTANCE:Abdominal pain after cholecystectomy is common and may be attributed to sphincter of Oddi dysfunction. Management often involves endoscopic retrograde cholangiopancreatography (ERCP) with manometry and sphincterotomy. OBJECTIVE:To determine whether endoscopic sphincterotomy reduces pain and whether sphincter manometric pressure is predictive of pain relief. DESIGN, SETTING, AND PATIENTS:Multicenter, sham-controlled, randomized trial involving 214 patients with pain after cholecystectomy without significant abnormalities on imaging or laboratory studies, and no prior sphincter treatment or pancreatitis randomly assigned (August 6, 2008-March 23, 2012) to undergo sphincterotomy or sham therapy at 7 referral medical centers. One-year follow-up was blinded. The final follow-up visit was March 21, 2013. INTERVENTIONS:After ERCP, patients were randomized 2:1 to sphincterotomy (n?=?141) or sham (n?=?73) irrespective of manometry findings. Those randomized to sphincterotomy with elevated pancreatic sphincter pressures were randomized again (1:1) to biliary or to both biliary and pancreatic sphincterotomies. Seventy-two were entered into an observational study with conventional ERCP managemeny. MAIN OUTCOMES AND MEASURES:Success of treatment was defined as less than 6 days of disability due to pain in the prior 90 days both at months 9 and 12 after randomization, with no narcotic use and no further sphincter intervention. RESULTS:Twenty-seven patients (37%; 95% CI, 25.9%-48.1%) in the sham treatment group vs 32 (23%; 95% CI, 15.8%-29.6%) in the sphincterotomy group experienced successful treatment (adjusted risk difference, -15.6%; 95% CI, -28.0% to -3.3%; P?=?.01). Of the patients with pancreatic sphincter hypertension, 14 (30%; 95% CI, 16.7%-42.9%) who underwent dual sphincterotomy and 10 (20%; 95% CI, 8.7%-30.5%) who underwent biliary sphincterotomy alone experienced successful treatment. Thirty-seven treated patients (26%; 95% CI,19%-34%) and 25 patients (34%; 95% CI, 23%-45%) in the sham group underwent repeat ERCP interventions (P?=?.22). Manometry results were not associated with the outcome. No clinical subgroups appeared to benefit from sphincterotomy more than others. Pancreatitis occurred in 15 patients (11%) after primary sphincterotomies and in 11 patients (15%) in the sham group. Of the nonrandomized patients in the observational study group, 5 (24%; 95% CI, 6%-42%) who underwent biliary sphincterotomy, 12 (31%; 95% CI, 16%-45%) who underwent dual sphincterotomy, and 2 (17%; 95% CI, 0%-38%) who did not undergo sphincterotomy had successful treatment. CONCLUSIONS AND RELEVANCE:In patients with abdominal pain after cholecystectomy undergoing ERCP with manometry, sphincterotomy vs sham did not reduce disability due to pain. These findings do not support ERCP and sphincterotomy for these patients. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00688662.

SUBMITTER: Cotton PB

PROVIDER: S-EPMC4428324 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial.

Cotton Peter B PB Durkalski Valerie V Romagnuolo Joseph J Pauls Qi Q Fogel Evan E Tarnasky Paul P Aliperti Giuseppe G Freeman Martin M Kozarek Richard R Jamidar Priya P Wilcox Mel M Serrano Jose J Brawman-Mintzer Olga O Elta Grace G Mauldin Patrick P Thornhill Andre A Hawes Robert R Wood-Williams April A Orrell Kyle K Drossman Douglas D Robuck Patricia P

JAMA 20140501 20

<h4>Importance</h4>Abdominal pain after cholecystectomy is common and may be attributed to sphincter of Oddi dysfunction. Management often involves endoscopic retrograde cholangiopancreatography (ERCP) with manometry and sphincterotomy.<h4>Objective</h4>To determine whether endoscopic sphincterotomy reduces pain and whether sphincter manometric pressure is predictive of pain relief.<h4>Design, setting, and patients</h4>Multicenter, sham-controlled, randomized trial involving 214 patients with pa ...[more]

PMID: 24867013

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Project description:BackgroundBiliopancreatic-type postcholecystectomy pain, without significant abnormalities on imaging and laboratory test results, has been categorized as "suspected" sphincter of Oddi dysfunction (SOD) type III. Clinical predictors of "manometric" SOD are important to avoid unnecessary ERCP, but are unknown.ObjectiveTo assess which clinical factors are associated with abnormal sphincter of Oddi manometry (SOM).DesignProspective, cross-sectional.SettingTertiary.PatientsA total of 214 patients with suspected SOD type III underwent ERCP and pancreatic SOM (pSOM; 85% dual SOM), at 7 U.S. centers (from August 2008 to March 2012) as part of a randomized trial.InterventionsPain and gallbladder descriptors, psychosocial/functional disorder questionnaires.Main outcome measurementsAbnormal SOM findings. Univariate and multivariate analyses assessed associations between clinical characteristics and outcome.ResultsThe cohort was 92% female with a mean age of 38 years. Baseline pancreatic enzymes were increased in 5%; 9% had minor liver enzyme abnormalities. Pain was in the right upper quadrant (RUQ) in 90% (48% also epigastric); 51% reported daily abdominal discomfort. Fifty-six took narcotics an average of 33 days (of the past 90 days). Less than 10% experienced depression or anxiety. Functional disorders were common. At ERCP, 64% had abnormal pSOM findings (34% both sphincters, 21% biliary normal), 36% had normal pSOM findings, and 75% had at least abnormal 1 sphincter. Demographic factors, gallbladder pathology, increased pancreatobiliary enzymes, functional disorders, and pain patterns did not predict abnormal SOM findings. Anxiety, depression, and poorer coping were more common in patients with normal SOM findings (not significant on multivariate analysis).LimitationsGeneralizability.ConclusionsPatient and pain factors and psychological comorbidity do not predict SOM results at ERCP in suspected type III SOD. (Clinical trial registration numberNCT00688662.).

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:Post-endoscopic sphincterotomy bleeding is a common complication of biliary sphincterotomy, and the incidence varies from 1% to 48%. It can be challenging to localize the bleeder or to administer various interventions through a side-viewing endoscope. This study aimed to evaluate the risk factors of post-endoscopic sphincterotomy bleeding and the outcome of endoscopic intervention therapies. We retrospectively reviewed the records of 513 patients who underwent biliary sphincterotomy in Mackay Memorial Hospital between 2011 and 2016. The blood biochemistry, comorbidities, indication for sphincterotomy, severity of bleeding, endoscopic features of bleeder, and type of endoscopic therapy were analyzed. Post-endoscopic sphincterotomy bleeding occurred in 65 (12.6%) patients. Forty-five patients had immediate bleeding and 20 patients had delayed bleeding. The multivariate analysis of risk factors associated with post-endoscopic sphincterotomy bleeding were liver cirrhosis (P = 0.029), end-stage renal disease (P = 0.038), previous antiplatelet drug use (P<0.001), and duodenal ulcer (P = 0.023). The complications of pancreatitis and cholangitis were higher in the bleeding group, with statistical significance. Delayed bleeding occurred within 1 to 7 days (mean, 2.5 days), and 60% (12/20) of the patients received endoscopic evaluation. In the delayed bleeding group, the successful hemostasis rate was 71.4% (5/7), and 65% (13/20) of the patients had ceased bleeding without endoscopic hemostasis therapy. Comparison of different therapeutic modalities showed that cholangitis was higher in patients who received epinephrine spray (P = 0.042) and pancreatitis was higher in patients who received epinephrine injection and electrocoagulation (P = 0.041 and P = 0.039 respectively). Clinically, post-endoscopic sphincterotomy bleeding and further endoscopic hemostasis therapy increase the complication rate of pancreatitis and cholangitis. Realizing the effectiveness of each therapeutic modalities and appropriate management of different levels bleeding are important.

Dataset Information

Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial.

Publications

Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial.

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