Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction

Completed · Not applicable

Conditions studied: Sphincter of Oddi Dysfunction

In brief

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.

Key facts

Study ID

NCT00688662

Run by

Medical University of South Carolina

People needed

214

Starts

2008-07-01

Expected to finish

2016-12-01

Last updated by the study team

2018-04-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Subjects on antidepressants for pain control (not required) should be taking them for a minimum of one month prior to the baseline assessment.
• Patients with SOD with depressive and/or anxiety disorders who receive psychopharmacologic treatment must be on stable medication dose for at least 6 weeks.
• Access to a telephone. 11.Must be able to speak, read, and write English. 12.Signed and dated informed consent.

You may not qualify if…

• 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:
• Lifetime psychotic disorders, bipolar disorder;
• Substance use disorders within 6 months;
• Eating disorders within 2 years
• Moderate \& severe depression defined by BDI-II (Beck Depression Inventory) cutoff scores >22 (unless receiving stable psychiatric therapy for six weeks); and/or,
• Suicidal risk (equal to or greater than "low") using MINI suicide section or a score of greater than 0 on question 9 of the BDI.
• The total number of days in the previous 3 months that the subject has taken prescription analgesics due to episodes of abdominal pain is greater than the total number of days the subject had episodes of abdominal pain.
• Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
• ERCP Criteria:
• Pancreas divisum (complete or partial) (known or discovered at study ERCP).
• Any pathology found at ERCP (except sphincter hypertension).
• Failed pancreatic manometry.

Where it is running

• Yale University — New Haven, Connecticut, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Midwest Therapeutic Endoscopy Consultants — St Louis, Missouri, United States
• Medical University of South Carolina Digestive Disease Center — Charleston, South Carolina, United States
• Methodist Dallas Medical Center — Dallas, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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