Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction (NCT00688662) | Clinical Trial Compass
CompletedNot Applicable
Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction
United States214 participantsStarted 2008-07
Plain-language summary
The Evaluating Predictors \& Interventions in Sphincter of Oddi Dysfunction(SOD) study (EPISOD) is a randomized sham-controlled study of biliary and pancreatic sphincterotomy as treatment for patients with pain after cholecystectomy fitting the criteria for sphincter of Oddi dysfunction type III.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Patients diagnosed with the clinical syndrome of SOD, as defined by the Modified Functional Biliary Disorders Module of the Rome III criteria
✓. Pain burden of Grade 3 or higher on RAPID Questionnaire.
✓. Cholecystectomy more than 90 days before enrollment.
✓. Laboratory Tests: Results of blood tests taken within 1 week preceding the baseline visit and any others available from the preceding 6 months (post-cholecystectomy):Direct bilirubin, alkaline phosphatase, amylase and lipase results must be no greater than 2 X the upper level of normal.Transaminase levels can be no more than 3 X upper limit of normal. If the transaminases are elevated (\<2X ULN) in association with a pain attack, they cannot have returned to normal within 3 days.
✓. Normal abdominal imaging by CT or MR/MRCP with bile duct reported at ≤9mm.
✓. Upper endoscopy examination without findings to explain the pain.
✓. Pain persisting despite a one trial of acid suppressant medications for one month (if tolerated).
✓. Pain persisting despite a trial of antispasmodics.
Exclusion criteria
✕. Prior ERCP treatment.
✕. Age \< 18 or Age \> 65.
✕. Pregnancy: Women who are pregnant at the time of Screening\* will be excluded from the study. (\*Note: Women who become pregnant AFTER the Baseline Visit/ERCP will be allowed to remain in the study for telephone follow-up visits).
✕. Prior gastric resection or surgery involving biliary diversion.
✕. Prior diagnosis of acute pancreatitis (lipase \>3 x ULN) including post-ERCP pancreatitis, or of chronic pancreatitis by radiological imaging, EUS 5 or more criteria, or Cambridge criteria moderate or more on ERCP.
✕. Daily use of prescription analgesics over the previous month.
✕. Abdominal discomfort every day for the past month at level of 3 or more on a scale of 1-10.
✕. Presence of significant psychiatric disorders: