Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction

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 ( 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.