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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Peter Cotton, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier:
First received: May 30, 2008
Last updated: June 17, 2016
Last verified: June 2016
Results First Received: April 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (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
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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
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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]
<=18 years   0   0   0 
Between 18 and 65 years   141   73   214 
>=65 years   0   0   0 
[Units: Participants]
Female   128   69   197 
Male   13   4   17 
Region of Enrollment 
[Units: Participants]
United States   141   73   214 

  Outcome Measures
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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
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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
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  More Information
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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
Study First Received: May 30, 2008
Results First Received: April 13, 2015
Last Updated: June 17, 2016