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Sphincter of Oddi Manometry: Reproducibility of Measurements and Effect of Sphincterotomy in the EPISOD Study.

ABSTRACT: BACKGROUND/AIMS:The reproducibility of sphincter of Oddi manometry (SOM) measurements and results of SOM after sphincterotomy has not been studied sufficiently. The aim of our study is to evaluate the reproducibility of SOM and completeness of sphincter ablation. METHODS:The recently published Evaluating Predictors and Interventions in sphincter of Oddi dysfunction (EPISOD) study included 214 subjects with post-cholecystectomy pain, and fit the criteria of sphincter of Oddi dysfunction type III. They were randomized into 3 arms, irrespective of manometric findings: sham (no sphincterotomy), biliary sphincterotomy, and dual (biliary and pancreatic). Thirty-eight subjects had both biliary and pancreatic manometries performed twice, at baseline and at repeat endoscopic retrograde cholangiopancreatography after 1-11 months. Sham arm was examined to assess the reproducibility of manometry, and the treatment arms to assess whether the sphincterotomies were complete (elevated pressures were normalized). RESULTS:Biliary and pancreatic measurements were reproduced in 7/14 (50%) untreated subjects. All 12 patients with initially elevated biliary pressures in biliary and dual sphincterotomy groups normalized after biliary sphincterotomy. However, 2 of 8 subjects with elevated pancreatic pressures in the dual sphincterotomy group remained abnormal after pancreatic sphincterotomy. Paradoxically, normal biliary pressures became abnormal in 1 of 15 subjects after biliary sphincterotomy, and normal pancreatic pressures became abnormal in 5 of 15 patients after biliary sphincterotomy, and in 1 of 9 after pancreatic sphincterotomy. CONCLUSIONS:Our data suggest that SOM measurements are poorly reproducible, and question whether we could adequately perform pancreatic sphincterotomy.

SUBMITTER: Suarez AL

PROVIDER: S-EPMC4930303 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Sphincter of Oddi Manometry: Reproducibility of Measurements and Effect of Sphincterotomy in the EPISOD Study.

Suarez Alejandro L AL Pauls Qi Q Durkalski-Mauldin Valerie V Cotton Peter B PB

Journal of neurogastroenterology and motility 20160701 3

<h4>Background/aims</h4>The reproducibility of sphincter of Oddi manometry (SOM) measurements and results of SOM after sphincterotomy has not been studied sufficiently. The aim of our study is to evaluate the reproducibility of SOM and completeness of sphincter ablation.<h4>Methods</h4>The recently published Evaluating Predictors and Interventions in sphincter of Oddi dysfunction (EPISOD) study included 214 subjects with post-cholecystectomy pain, and fit the criteria of sphincter of Oddi dysfun ...[more]

PMID: 26951046

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Project description: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.

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.).

Dataset Information

Sphincter of Oddi Manometry: Reproducibility of Measurements and Effect of Sphincterotomy in the EPISOD Study.

Publications

Sphincter of Oddi Manometry: Reproducibility of Measurements and Effect of Sphincterotomy in the EPISOD Study.

Similar Datasets

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