Trial Outcomes & Findings for Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction (NCT NCT00688662)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

214 participants

Primary outcome timeframe

1 year

Results posted on

2018-04-19

Participant Flow

Subjects were recruited from medical clinics in 6 gastroenterology referral centers in USA between August 6 2008 and March 23 2012.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	141	73
Overall Study COMPLETED	118	55
Overall Study NOT COMPLETED	23	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1. ERCP With Sphincterotomy n=141 Participants Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincter manometry and biliary and/or pancreatic sphincterotomy and pancreatic stenting	2. ERCP Without Sphincterotomy n=73 Participants Endoscopic Retrograde CholangioPancreatography(ERCP) with sphincter manometry and pancreatic stenting, but without sphincterotomy	Total n=214 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	141 Participants n=5 Participants	73 Participants n=7 Participants	214 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	69 Participants n=7 Participants	197 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	141 participants n=5 Participants	73 participants n=7 Participants	214 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The primary analysis was conducted with the intention-to-treat population defined as all randomized patients.

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.

Outcome measures

Outcome measures
Measure	1.ERCP With Sphincterotomy n=141 Participants ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)	2. ERCP Without Sphincterotomy n=73 Participants ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
Percentage of Participants With Success	23 percentage of paricipants with success Interval 15.8 to 29.6	37 percentage of paricipants with success Interval 25.9 to 48.1

SECONDARY outcome

Timeframe: 1 year

Population: Participants with abnormal sphincter manometry

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.

Outcome measures

Outcome measures
Measure	1.ERCP With Sphincterotomy n=110 Participants ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)	2. ERCP Without Sphincterotomy n=52 Participants ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
Percentage of Patients With a Successful Primary Outcome, Out of Those With Abnormal Sphincter Manometry.	24 percentage of participants with success	33 percentage of participants with success

Adverse Events

1.ERCP With Sphincterotomy

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

2. ERCP Without Sphincterotomy

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1.ERCP With Sphincterotomy n=141 participants at risk ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)	2. ERCP Without Sphincterotomy n=73 participants at risk ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
Gastrointestinal disorders Pancreatitis	10.6% 15/141 • One year after randomization	15.1% 11/73 • One year after randomization
Gastrointestinal disorders Perforation	0.71% 1/141 • One year after randomization	1.4% 1/73 • One year after randomization

Other adverse events

Adverse event data not reported

Additional Information

Dr Peter Cotton

Medical University of South Carolina

Phone: 8438767217

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place