Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction (EPISOD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688662
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : July 28, 2016
Last Update Posted : April 19, 2018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Peter Cotton, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sphincter of Oddi Dysfunction
Interventions: Procedure: ERCP with sphincterotomy
Procedure: ERCP without sphincterotomy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from medical clinics in 6 gastroenterology referral centers in USA between August 6 2008 and March 23 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
1.ERCP With Sphincterotomy Endoscopic Retrograde CholangioPancreatography (ERCP) with biliary and/or pancreatic sphincterotomy
2. ERCP Without Sphincterotomy: Endoscopic Retrograde CholangioPancreatography (ERCP) without biliary and/or pancreatic sphincterotomy

Participant Flow:   Overall Study
    1.ERCP With Sphincterotomy   2. ERCP Without Sphincterotomy:
STARTED   141   73 
COMPLETED   118   55 
NOT COMPLETED   23   18 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
1. ERCP With Sphincterotomy Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincter manometry and biliary and/or pancreatic sphincterotomy and pancreatic stenting
2. ERCP Without Sphincterotomy Endoscopic Retrograde CholangioPancreatography(ERCP) with sphincter manometry and pancreatic stenting, but without sphincterotomy
Total Total of all reporting groups

Baseline Measures
   1. ERCP With Sphincterotomy   2. ERCP Without Sphincterotomy   Total 
Overall Participants Analyzed 
[Units: Participants]
 141   73   214 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      141 100.0%      73 100.0%      214 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      128  90.8%      69  94.5%      197  92.1% 
Male      13   9.2%      4   5.5%      17   7.9% 
Region of Enrollment 
[Units: Participants]
United States   141   73   214 

  Outcome Measures

1.  Primary:   Percentage of Participants With Success   [ Time Frame: 1 year ]

2.  Secondary:   Percentage of Patients With a Successful Primary Outcome, Out of Those With Abnormal Sphincter Manometry.   [ Time Frame: 1 year ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr Peter Cotton
Organization: Medical University of South Carolina
phone: 8438767217

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Peter Cotton, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT00688662     History of Changes
Other Study ID Numbers: DK074739
U01DK074739 ( U.S. NIH Grant/Contract )
First Submitted: May 30, 2008
First Posted: June 3, 2008
Results First Submitted: April 13, 2015
Results First Posted: July 28, 2016
Last Update Posted: April 19, 2018