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The EPISOD Trial is a two-arm parallel, randomized, double-blinded, sham-controlled, multicenter Phase III clinical trial of endoscopic sphincterotomy as treatment for adults 18 to 65 years of age diagnosed with SOD III. A minimum of 214 subjects will be randomized using a 2:1 allocation in favor of sphincterotomy and will be followed for 12 months post-randomization. The purpose of this research is to study which people with SOD best benefit from sphincterotomy. We will study how the treatment affects pain, quality of life, interference with routine daily tasks and the impact it has on the emotional and psychological well-being of persons with SOD. In addition, the EPISOD trial will examine medical care and costs associated with SOD.

Criteria Inclusion Criteria: - Patients diagnosed with the clinical syndrome of SOD - Prior cholecystectomy more than 90 days prior to 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 no greater than 2 times the upper limit of normal. Transaminase levels can be no more than 3 times the upper limit of normal. - Normal abdominal imaging by CT or MR/MRCP. - Upper endoscopy examination without findings to explain the pain. - Pain persisting despite a one month trial of PPIs and PRN 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. - Must be able to speak, read, and write English. - Signed and dated informed consent. 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: o Lifetime psychotic disorders, bipolar disorder; o Substance use disorders within 6 months; o Eating disorders within 2 years o Moderate & severe depression defined by BDI-II cutoff scores >14 (Beck Depression Inventory); and, o Suicidal risk (more 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.

You will need to speak with the study coordinator over the telephone, and if you meet certain criteria, you will be asked to come to Virginia Mason to meet with the study doctor.

At the clinic visit, your doctor will decide whether or not to recommend an investigation called Endoscopic Retrograde Cholangio-Pancreatography (ERCP), with pressure measurements (manometry). This may lead to treatment (during the ERCP), called sphincterotomy, to reduce the pressure and relieve the pain.

After the procedure, you will be asked to speak with the study coordinator monthly for one year.

Study Summary:

Detailed Study Description:

Study Design: Interventional, Blinded
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Sphincter of Oddi Dysfuntion Type III
Intervention Type: Procedure/Surgery
Intervention Name: Sphincterotomy
Gender: Male and Female
Age group: Interventional
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)