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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00688662 |
Purpose
Protocol Title:Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction(SOD) Acronym EPISOD
Clinical Trial Phase: Phase III
Study Sites Six 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:
Study Design 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.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sphincter of Oddi Dysfunction |
Procedure: Pancreatic Sphincterotomy Procedure: Pancreatic and Biliary Sphincterotomy Procedure: ERCP |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Phase III Randomized Multicenter Clinical Trial of Sphincterotomy for the Treatment of SOD III Patients |
| Estimated Enrollment: | 214 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Pancreatic Sphincterotomy
|
Procedure: Pancreatic Sphincterotomy
cutting the sphincter muscle (sphincterotomy)
Procedure: Pancreatic and Biliary Sphincterotomy
cutting the sphincter muscle (sphincterotomy)
|
|
2: Placebo Comparator
Sham procedure; during the ERCP no sphincterotomy procedure will be performed
|
Procedure: ERCP
ERCP Procedure: For the procedure, you will lie on your left side on an examining table in an x-ray room. You will be given medication to help numb the back of your throat and a sedative or anesthetic to help you relax during the exam. The physician will guide the scope through your esophagus, stomach, and duodenum until it reaches the spot where the ducts of the biliary tree and pancreas open into the duodenum. The physician will the pass a small plastic tube through the scope. Through the tube, the physician will inject a dye into the ducts to make them show up clearly on x rays. X rays are taken as soon as the dye is injected
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Presence of significant psychiatric disorders:
ERCP Criteria:
Contacts and Locations| Contact: Kyle B Orrell, MSHP | (843) 876-4303 | orrell@musc.edu |
| Contact: Rebekah Whichard, CCRC | (843) 876-7233 | richreb@musc.edu |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Toni Seay (205) 934-7332 tamartin@uab.edu | |
| Principal Investigator: C Mel Wilcox, MD | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Laura Lazzell-Pannell, BSN, RN 317-278-3119 llazzell@iupui.edu | |
| Contact: Suzette Schmidt, BSN, RN (317) 278-8104 suschmid@iupui.edu | |
| Principal Investigator: Evan Fogel, MD | |
| United States, Maryland | |
| Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Laurie McClelland, BSN, RN 410-955-3822 lam@jhmi.edu | |
| Principal Investigator: Anthony Kalloo, MD | |
| United States, Minnesota | |
| University of Minnesota | Active, not recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, South Carolina | |
| Medical University of South Carolina Digestive Disease Center | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Rebekah Whichard, CCRC 843-876-7233 richreb@musc.edu | |
| Contact: April Williams, CCRC (843) 876-7234 woodap@musc.edu | |
| Principal Investigator: Joseph Romagnuolo, MD | |
| United States, Texas | |
| Methodist Dallas Medical Center | Recruiting |
| Dallas, Texas, United States, 75203 | |
| Contact: Deanna J Jordan 214-947-4416 deannajordan@mhd.com | |
| Contact: Kimberly Kenyon (214) 941-6891 ext 128 kimberly.kenyon@DHAT.com | |
| Principal Investigator: Paul Tarnasky, MD | |
| United States, Washington | |
| Virginia Mason Medical Center | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Alice Stead 206-341-1450 alice.stead@vmmc.org | |
| Principal Investigator: Richard Kozarek, MD | |
| Principal Investigator: | Joseph Romagnuolo, MD | Medical Universtiy of South Carolina |
| Principal Investigator: | C Mel Wilcox, MD | University of Alabama at Birmingham |
| Principal Investigator: | Martin Freeman, MD | University of Minnesota |
| Principal Investigator: | Richard Kozarek, MD | Virginia Mason Medical Center |
| Principal Investigator: | Evan Fogel, MD | Indiana University |
| Principal Investigator: | Anthony Kalloo, MD | Johns Hopkins University |
| Study Chair: | Peter Cotton, MD | MUSC Digestive Disease Center |
| Principal Investigator: | Paul Tarnasky, MD | Digestive Health Associates of Texas |
More Information
| Responsible Party: | Medical University of South Carolina, Digestive Disease Center ( Peter Cotton M.D ) |
| Study ID Numbers: | DK074739 |
| Study First Received: | May 30, 2008 |
| Last Updated: | September 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00688662 History of Changes |
| Health Authority: | United States: Federal Government |
|
Sphincter of Oddi Dysfunction Pancreatitis Sphincterotomy |
|
Sphincter of Oddi Dysfunction Common Bile Duct Diseases Digestive System Diseases |
Bile Duct Diseases Biliary Tract Diseases Biliary Dyskinesia |