MedTrace Logo

Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction

NCT00688662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2018-04-19

Study results available
· View outcomes & findings →

Summary

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 sphincter of Oddi dysfunction type III.

Conditions

  • Sphincter of Oddi Dysfunction

Interventions

PROCEDURE

ERCP with sphincterotomy

cutting the biliary sphincter muscle (sphincterotomy)

PROCEDURE

ERCP without sphincterotomy

ERCP with sphincter manometry, but no sphincterotomy

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Joseph Romagnuolo, MD · Medical Universtiy of South Carolina

  • Martin Freeman, MD · University of Minnesota

  • Richard Kozarek, MD · Virginia Mason Medical Center

  • Evan Fogel, MD · Indiana University

  • Peter Cotton, MD · MUSC Digestive Disease Center

  • Paul Tarnasky, MD · Digestive Health Associates of Texas

  • Giuseppe Aliperti, MD · Midwest Therapeutic Endoscopy Consultants

  • Priya Jamidar, MD · Yale University

  • Jose Serrano · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2013-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00688662 on ClinicalTrials.gov