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

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ClinicalTrials.gov Identifier: NCT00688662
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : July 28, 2016
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
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
Enrollment 214
Recruitment Details Subjects were recruited from medical clinics in 6 gastroenterology referral centers in USA between August 6 2008 and March 23 2012.
Pre-assignment Details  
Arm/Group Title 1.ERCP With Sphincterotomy 2. ERCP Without Sphincterotomy:
Hide Arm/Group Description Endoscopic Retrograde CholangioPancreatography (ERCP) with biliary and/or pancreatic sphincterotomy Endoscopic Retrograde CholangioPancreatography (ERCP) without biliary and/or pancreatic sphincterotomy
Period Title: Overall Study
Started 141 73
Completed 118 55
Not Completed 23 18
Arm/Group Title 1. ERCP With Sphincterotomy 2. ERCP Without Sphincterotomy Total
Hide Arm/Group Description Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincter manometry and biliary and/or pancreatic sphincterotomy and pancreatic stenting Endoscopic Retrograde CholangioPancreatography(ERCP) with sphincter manometry and pancreatic stenting, but without sphincterotomy Total of all reporting groups
Overall Number of Baseline Participants 141 73 214
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 73 participants 214 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 73 participants 214 participants
Female
128
  90.8%
69
  94.5%
197
  92.1%
Male
13
   9.2%
4
   5.5%
17
   7.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 141 participants 73 participants 214 participants
141 73 214
1.Primary Outcome
Title Percentage of Participants With Success
Hide Description The primary outcome was a dichotomous (success/failure) variable. Success was defined as patients having a RAPID score of <6 days at months 9 and 12 post-procedure, without re-intervention and without use of prescription analgesics during months 10, 11 and 12 unless used for non-abdominal pain for no more than 14 days. The subject was considered a failure if the 12-month RAPID score was missing or collected outside the acceptable window. If the 9-month RAPID was missing, or outside of the window, then the 6-month value was used when available.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was conducted with the intention-to-treat population defined as all randomized patients.
Arm/Group Title 1.ERCP With Sphincterotomy 2. ERCP Without Sphincterotomy
Hide Arm/Group Description:
ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
Overall Number of Participants Analyzed 141 73
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of paricipants with success
23
(15.8 to 29.6)
37
(25.9 to 48.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1.ERCP With Sphincterotomy, 2. ERCP Without Sphincterotomy
Comments The trial was designed to test for an overall absolute difference of at least 30% in the primary outcome (‘success’) in patients treated with sphincterotomy compared to those treated with sham. Using a 2:1 allocation, an assumed 10% non-adherence rate, and one interim analysis for efficacy using O’Brien and Fleming boundaries and futility using conditional power, the study required 214 patients to be randomized to ensure greater than 90% likelihood of identifying this difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments The primary analysis was conducted using a logistic regression model with treatment group as the factor of interest and clinical center and PSH status as covariates. A Wald test using a two-tailed significance level of 0.0499 was conducted.
Method Regression, Logistic
Comments Adjusted and unadjusted risk differences with two-sided 95% confidence intervals are reported in the manuscript.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -15.6
Confidence Interval (2-Sided) 95%
-28.0 to -3.3
Estimation Comments The unadjusted risk difference and confidence interval was -14.3% (-27.3%, -1.2%).
2.Secondary Outcome
Title Percentage of Patients With a Successful Primary Outcome, Out of Those With Abnormal Sphincter Manometry.
Hide Description Successful outcome was defined using the primary outcome definition of success at 12 months post randomization. Abnormal sphincter manometry was determined as a basal pressure of more than 40mm Hg in both leads.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with abnormal sphincter manometry
Arm/Group Title 1.ERCP With Sphincterotomy 2.ERCP Without Sphincterotomy
Hide Arm/Group Description:
ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
Overall Number of Participants Analyzed 110 52
Measure Type: Number
Unit of Measure: percentage of participants with success
24 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1.ERCP With Sphincterotomy, 2.ERCP Without Sphincterotomy
Comments Only patients with abnormal manometry were included in this subgroup analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -9
Confidence Interval (2-Sided) 95%
-24.1 to 5.9
Estimation Comments [Not Specified]
Time Frame One year after randomization
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1.ERCP With Sphincterotomy 2. ERCP Without Sphincterotomy
Hide Arm/Group Description ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy) ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
All-Cause Mortality
1.ERCP With Sphincterotomy 2. ERCP Without Sphincterotomy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1.ERCP With Sphincterotomy 2. ERCP Without Sphincterotomy
Affected / at Risk (%) Affected / at Risk (%)
Total   16/141 (11.35%)   12/73 (16.44%) 
Gastrointestinal disorders     
Pancreatitis  1  15/141 (10.64%)  11/73 (15.07%) 
Perforation  1  1/141 (0.71%)  1/73 (1.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1.ERCP With Sphincterotomy 2. ERCP Without Sphincterotomy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/141 (0.00%)   0/73 (0.00%) 
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Cotton, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov 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