Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction (EPISOD)

This is an interventional treatment trial for Sphincter of Oddi Dysfunction focused on measuring Sphincter of Oddi Dysfunction, Pancreatitis, Sphincterotomy Read More

Inclusion Criteria:

1. Patients diagnosed with the clinical syndrome of SOD, as defined by the Modified Functional Biliary Disorders Module of the Rome III criteria
2. Pain burden of Grade 3 or higher on RAPID Questionnaire.
3. Cholecystectomy more than 90 days before enrollment.
4. 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.
5. Normal abdominal imaging by CT or MR/MRCP with bile duct reported at ≤9mm.
6. Upper endoscopy examination without findings to explain the pain.
7. Pain persisting despite a one trial of acid suppressant medications for one month (if tolerated).
8. Pain persisting despite a trial of antispasmodics.
9. Subjects on antidepressants for pain control (not required) should be taking them for a minimum of one month prior to the baseline assessment.

9.Patients with SOD with depressive and/or anxiety disorders who receive psychopharmacologic treatment must be on stable medication dose for at least 6 weeks.

10.Access to a telephone. 11.Must be able to speak, read, and write English. 12.Signed and dated informed consent.

Exclusion Criteria:

1. Prior ERCP treatment.
2. Age < 18 or Age > 65.
3. 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).
4. Prior gastric resection or surgery involving biliary diversion.
5. 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.
6. Daily use of prescription analgesics over the previous month.
7. Abdominal discomfort every day for the past month at level of 3 or more on a scale of 1-10.

8. Presence of significant psychiatric disorders:

   1. Lifetime psychotic disorders, bipolar disorder;
   2. Substance use disorders within 6 months;
   3. Eating disorders within 2 years
   4. Moderate & severe depression defined by BDI-II (Beck Depression Inventory) cutoff scores >22 (unless receiving stable psychiatric therapy for six weeks); and/or,
   5. 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.
9. 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.
10. Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.

ERCP Criteria:

1. Pancreas divisum (complete or partial) (known or discovered at study ERCP).
2. Any pathology found at ERCP (except sphincter hypertension).
3. Failed pancreatic manometry.