Status:
COMPLETED
Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Sphincter of Oddi Dysfunction
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Detailed Description
Clinical Trial Phase: Phase III Study Sites Seven clinical centers in US Study Period Planned enrollment period - 3 years Planned duration of the study - 5 years Study Population SOD III Patients ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00688662
Start Date
July 1 2008
End Date
December 1 2016
Last Update
April 19 2018
Active Locations (7)
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1
Yale University
New Haven, Connecticut, United States, 06510
2
Indiana University
Indianapolis, Indiana, United States, 46202
3
University of Minnesota
Minneapolis, Minnesota, United States, 55415
4
Midwest Therapeutic Endoscopy Consultants
St Louis, Missouri, United States, 63141