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Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients

Primary Purpose

Post-ERCP Pancreatitis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Indomethacin
Placebo suppositories
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-ERCP Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Included patients are those undergoing ERCP and have one of the following:

  1. Clinical suspicion of sphincter of Oddi dysfunction
  2. History of post-ERCP pancreatitis (at least one episode)
  3. Pancreatic sphincterotomy
  4. Pre-cut (access) sphincterotomy
  5. > 8 cannulation attempts
  6. Pneumatic dilation of intact biliary sphincter
  7. Ampullectomy

or at least 2 of the following:

  1. Age < 50 years old & female gender
  2. History of recurrent pancreatitis (at least 2 episodes)
  3. ≥3 pancreatic injections, with at least one injection to tail
  4. Pancreatic acinarization
  5. Pancreatic brush cytology

Exclusion Criteria:

  1. Unwillingness or inability to consent for the study
  2. Age < 18 years
  3. Intrauterine pregnancy
  4. Breast feeding mother
  5. Standard contraindications to ERCP
  6. Allergy to Aspirin or NSAIDs
  7. Renal failure (Cr > 1.4)
  8. Active or recent (within 4 weeks) gastrointestinal hemorrhage
  9. Acute pancreatitis (lipase peak) within 72 hours
  10. Known chronic calcific pancreatitis
  11. Pancreatic head malignancy
  12. Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla)
  13. ERCP for biliary stent removal or exchange without anticipated pancreatogram
  14. Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
  15. Anticipated inability to follow protocol
  16. Endoscopist discretion: low risk (<10%) of post-ERCP pancreatitis

Sites / Locations

  • Indiana University Medical Center
  • University of Kentucky
  • University of Michigan
  • University Hospitals Case Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Indomethacin suppository

Placebo suppository

Outcomes

Primary Outcome Measures

Post-ERCP Pancreatitis
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2009
Last Updated
February 21, 2013
Sponsor
University of Michigan
Collaborators
Indiana University School of Medicine, University of Kentucky, Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT00820612
Brief Title
Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
Official Title
A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Stopped by DSMB for overwhelming benefit of indomethacin (unethical to withhold indomethacin from patients)
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Indiana University School of Medicine, University of Kentucky, Case Western Reserve University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct. Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.
Detailed Description
This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Pancreatitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
602 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Indomethacin suppository
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo suppository
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Intervention Description
100 mg PR once at the time of ERCP
Intervention Type
Other
Intervention Name(s)
Placebo suppositories
Intervention Description
2 placebo suppositories at the time of ERCP
Primary Outcome Measure Information:
Title
Post-ERCP Pancreatitis
Description
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Included patients are those undergoing ERCP and have one of the following: Clinical suspicion of sphincter of Oddi dysfunction History of post-ERCP pancreatitis (at least one episode) Pancreatic sphincterotomy Pre-cut (access) sphincterotomy > 8 cannulation attempts Pneumatic dilation of intact biliary sphincter Ampullectomy or at least 2 of the following: Age < 50 years old & female gender History of recurrent pancreatitis (at least 2 episodes) ≥3 pancreatic injections, with at least one injection to tail Pancreatic acinarization Pancreatic brush cytology Exclusion Criteria: Unwillingness or inability to consent for the study Age < 18 years Intrauterine pregnancy Breast feeding mother Standard contraindications to ERCP Allergy to Aspirin or NSAIDs Renal failure (Cr > 1.4) Active or recent (within 4 weeks) gastrointestinal hemorrhage Acute pancreatitis (lipase peak) within 72 hours Known chronic calcific pancreatitis Pancreatic head malignancy Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla) ERCP for biliary stent removal or exchange without anticipated pancreatogram Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram Anticipated inability to follow protocol Endoscopist discretion: low risk (<10%) of post-ERCP pancreatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Badih J Elmunzer, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22494121
Citation
Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.
Results Reference
derived

Learn more about this trial

Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients

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