- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01912716
Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis
June 24, 2019 updated by: Evan Fogel, Indiana University
Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients: Searching for the Optimal Dose. A Prospective, Randomized Trial
It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of 100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk patients.
However, the optimal dose required is not known.
The purpose of this study is to determine whether a dose of 200 mg, administered as rectal suppositories, is more effective than the standard dose of 100 mg.
An ERCP procedure is a scope procedure where a lighted tube with a camera is passed down the patient's throat and allows for evaluation of the bile duct and/or pancreatic duct.
The most common side effect of this procedure is post-ERCP pancreatitis, or swelling of the pancreas.
Some patients are at higher risk for this complication than others.
Our hypothesis is to compare the efficacy of these two dose regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the frequency and severity of post-ERCP pancreatitis in high-risk patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
After obtaining informed consent, subjects will undergo ERCP per clinical protocol.
All procedure-related clinical decisions and interventions will be dictated by the performing physician as he or she sees fit.
At the end of the procedure, it will be determined by the endoscopist and research coordinator whether the patient meets inclusion criteria.
If inclusion criteria are met, subjects will be randomized by concealed allocation to receive either 100mg or 150mg indomethacin, in the form of two or three 50mg rectal suppositories.
Those patients who are randomized to receive the 100mg dose will receive an additional glycerin suppository.
Four hours later, those patients who were randomized to the high-dose group will then receive an additional 50mg suppository while in the recovery area.
At this same time point, subjects who were randomized to the standard-dose group, will receive a glycerin suppository in the recovery area.
All participating patients will receive a total of 4 suppositories.
Study Type
Interventional
Enrollment (Actual)
1037
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Health
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Medical Center
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Texas
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Dallas, Texas, United States, 75203
- Methodist Dallas Medical Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53220
- Aurora St. Lukes' Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Included patients are those undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and have:
one of the following:
- Clinical suspicion of sphincter of Oddi dysfunction (SOD; type I or II)
- History of post-ERCP pancreatitis (at least one episode)
- Pancreatic sphincterotomy
- Pre-cut (access) sphincterotomy
- greater than 8 cannulation attempts of any sphincter
- Pneumatic dilation of intact biliary sphincter
- Ampullectomy 8.) Assessment for post-sphincterotomy stenosis
OR at least 2 of the following:
- Age less than 50 years old and female gender
- History of recurrent pancreatitis (at least 2 episodes)
- greater than or equal to to 3 pancreatic injections, with at least 1 injection to tail
- Pancreatic acinarization (excluding ventral pancreas of pancreas divisum)
- Pancreatic brush cytology -
Exclusion Criteria:
- Unwillingness or inability to consent for the study
- Age less than 18 years
- Intrauterine pregnancy
- Breastfeeding mother
- Standard contraindications to ERCP
- Allergy/hypersensitivity to aspirin or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
- Received NSAIDs in prior 7 days (aspirin 325mg or less ok)
- Renal failure (serum creatinine greater than 1.4)
- Active or recurrent (within 4 weeks) gastrointestinal hemorrhage
- Acute pancreatitis (lipase peak) within 72 hours
- Known chronic calcific pancreatitis
- Pancreatic head mass
- Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas divisum (dorsal duct not attempted on injected)
- ERCP for biliary stent removal or exchange without anticipated pancreatogram
- Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
- Anticipated inability to follow protocol
- Known active cardiovascular or cerebrovascular disease -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: high-dose indomethacin
200mg rectal indomethacin
|
patients randomized to this intervention receive 200mg indomethacin
Other Names:
|
Active Comparator: standard dose indomethacin
100mg rectal indomethacin
|
patients randomized to this intervention receive 100mg indomethacin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Developed Post-ERCP Pancreatitis
Time Frame: 5 days
|
Assessment of whether patients developed post-ERCP pancreatitis, defined as a new onset of pain (or worsening of existing pain) in the upper abdomen, an elevation in pancreatic enzymes of at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least two nights.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Moderate or Severe Post-ERCP Pancreatitis
Time Frame: 30 days
|
Assessment of whether patients developed either moderate or severe post-ERCP pancreatitis, defined according to established consensus criteria (Cotton et al., Gastrointestinal Endoscopy 1991;37:383-93).
Severity of post-ERCP pancreatitis is partly defined according to length of stay.
Moderate pancreatitis is defined as a 4-10 day hospitalization.
Severe post-ERCP pancreatitis is defined as a hospitalization of greater than 10 days post-ERCP, or development of a complication (eg.
pseudocyst or necrosis), or need for intervention (drainage or surgery).
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Evan L Fogel, MD, MSc, Indiana University Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
July 29, 2013
First Submitted That Met QC Criteria
July 30, 2013
First Posted (Estimate)
July 31, 2013
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
June 24, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pancreatic Diseases
- Pancreatitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Reproductive Control Agents
- Gout Suppressants
- Tocolytic Agents
- Indomethacin
Other Study ID Numbers
- PEP INDO 2013
- ACG-CR-002-2013 (Other Grant/Funding Number: American College of Gastroenterology)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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