Joseph Romagnuolo1, Peter B Cotton1, Valerie Durkalski1, Qi Pauls1, Olga Brawman-Mintzer1, Douglas A Drossman2, Patrick Mauldin1, Kyle Orrell3, April W Williams1, Evan L Fogel4, Paul R Tarnasky3, Giuseppe Aliperti5, Martin L Freeman6, Richard A Kozarek7, Priya A Jamidar8, C Mel Wilcox9, Jose Serrano10, Grace H Elta11. 1. Medical University of South Carolina, Charleston, South Carolina, USA. 2. University of North Carolina, Chapel Hill, North Carolina, USA. 3. Digestive Health Associates of Texas, Dallas, Texas, USA. 4. Indiana University, Indianapolis, Indiana, USA. 5. Midwest Therapeutic Endoscopy, St. Louis, Missouri, USA. 6. University of Minnesota, Minneapolis, Minnesota, USA. 7. Virginia Mason, Seattle, Washington, USA. 8. Yale University, New Haven, Connecticut, USA. 9. University of Alabama, Birmingham, Alabama, USA. 10. National Institute of Diabetes and Digestive and Kidney Diseases, Division of Digestive Diseases and Nutrition, National Institutes of Health, Bethesda, Maryland, USA. 11. University of Michigan, Ann Arbor, Michigan, USA.
Abstract
BACKGROUND: Biliopancreatic-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. OBJECTIVE: To assess which clinical factors are associated with abnormal sphincter of Oddi manometry (SOM). DESIGN: Prospective, cross-sectional. SETTING: Tertiary. PATIENTS: A total of 214 patients with suspected SOD type III underwentERCP and pancreatic SOM (pSOM; 85% dual SOM), at 7 U.S. centers (from August 2008 to March 2012) as part of a randomized trial. INTERVENTIONS:Pain and gallbladder descriptors, psychosocial/functional disorder questionnaires. MAIN OUTCOME MEASUREMENTS: Abnormal SOM findings. Univariate and multivariate analyses assessed associations between clinical characteristics and outcome. RESULTS:The 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). LIMITATIONS: Generalizability. CONCLUSIONS: Patient and pain factors and psychological comorbidity do not predict SOM results at ERCP in suspected type III SOD. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00688662.).
RCT Entities:
BACKGROUND:Biliopancreatic-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. OBJECTIVE: To assess which clinical factors are associated with abnormal sphincter of Oddi manometry (SOM). DESIGN: Prospective, cross-sectional. SETTING: Tertiary. PATIENTS: A 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. INTERVENTIONS:Pain and gallbladder descriptors, psychosocial/functional disorder questionnaires. MAIN OUTCOME MEASUREMENTS: Abnormal SOM findings. Univariate and multivariate analyses assessed associations between clinical characteristics and outcome. RESULTS: The 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). LIMITATIONS: Generalizability. CONCLUSIONS:Patient and pain factors and psychological comorbidity do not predict SOM results at ERCP in suspected type III SOD. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00688662.).
Authors: Peter B Cotton; Valerie Durkalski; Kyle B Orrell; Olga Brawman-Mintzer; Douglas A Drossman; C Mel Wilcox; Patrick D Mauldin; Grace H Elta; Paul R Tarnasky; Evan L Fogel; Sanjay B Jagganath; Richard A Kozarek; Martin L Freeman; Joseph Romagnuolo; Patricia R Robuck Journal: Gastrointest Endosc Date: 2010-11 Impact factor: 9.427
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Authors: Peter B Cotton; Valerie Durkalski; Joseph Romagnuolo; Qi Pauls; Evan Fogel; Paul Tarnasky; Giuseppe Aliperti; Martin Freeman; Richard Kozarek; Priya Jamidar; Mel Wilcox; Jose Serrano; Olga Brawman-Mintzer; Grace Elta; Patrick Mauldin; Andre Thornhill; Robert Hawes; April Wood-Williams; Kyle Orrell; Douglas Drossman; Patricia Robuck Journal: JAMA Date: 2014-05 Impact factor: 56.272