This trial is active, not recruiting.

Condition sphincter of oddi dysfunction
Treatments ercp with biliary sphincterotomy, ercp with biliary and pancreatic sphincterotomies, ercp without sphincterotomy
Phase phase 3
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date July 2008
End date December 2013
Trial size 214 participants
Trial identifier NCT00688662, DK074739


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 sphincterof Oddi dysfuntion type III

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
ERCP with biliary sphincterotomy
ercp with biliary sphincterotomy
cutting the biliary sphincter muscle (sphincterotomy)
(Placebo Comparator)
ERCP without sphincterotomy
ercp without sphincterotomy
ERCP with sphincter manometry, but no sphincterotomy
(Active Comparator)
ERCP with biliary and pancreatic sphincterotomies
ercp with biliary and pancreatic sphincterotomies
cutting the biliary and pancreatic sphincter muscles (sphincterotomy)

Primary Outcomes

To ascertain whether subjects with SOD III respond to sphincterotomy,
time frame: 5 years

Secondary Outcomes

the association between the results of Sphincter of Oddi Manometry (SOM) (abnormal/normal) and the primary outcome (success/failure)
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title A Phase III Randomized Multicenter Clinical Trial of Sphincterotomy for the Treatment of SOD III Patients
Principal investigator Joseph Romagnuolo, MD
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 Primary Study Objective: To ascertain whether subjects with SOD III respond to sphincterotomy, Secondary Study Objectives To evaluate: - the association between the results of Sphincter of Oddi Manometry (SOM) (abnormal/normal) and the primary outcome (success/failure); - the success rate (as defined in the primary) of subjects who receive biliary sphincterotomy alone versus subjects who receive both biliary and pancreatic sphincterotomy in the subgroup of patients with manometrically proven hypertension of the pancreatic sphincter; - the effects of pre-specified prognostic factors on the primary outcome; - anxiety and depression scores over time and their relation to study outcomes; - the economic impact of SOD III, and of endoscopic sphincterotomy in patients with SOD III; and, to, - conduct a careful follow-up study (EPISOD2) of standard of care treatment (separate protocol). Study Design The EPISOD Trial is a 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. Sample Size 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).