Trial record 19 of 512 for:    pancreatitis

Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01912716
Recruitment Status : Recruiting
First Posted : July 31, 2013
Last Update Posted : October 31, 2017
American College of Gastroenterology
University of Michigan
University of Texas
Aurora Health Care
Medical University of South Carolina
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Evan Fogel, Indiana University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-ERCP Pancreatitis Drug: high dose indomethacin Other: standard dose Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 1036 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients: Searching for the Optimal Dose. A Prospective, Randomized Trial
Study Start Date : July 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: high-dose indomethacin
200mg rectal indomethacin
Drug: high dose indomethacin
Active Comparator: standard dose indomethacin
100mg rectal indomethacin
Other: standard dose

Primary Outcome Measures :
  1. frequency of pancreatitis [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. severity of pancreatitis [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Included patients are those undergoing ERCP and have:

one of the following:

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

OR at least 2 of the following:

  1. Age <50 years old and female gender
  2. History of recurrent pancreatitis (at least 2 episodes)
  3. > or = to 3 pancreatic injections, with at least 1 injection to tail
  4. Pancreatic acinarization (excluding ventral pancreas of pancreas divisum)
  5. Pancreatic brush cytology -

Exclusion Criteria:

  1. Unwillingness or inability to consent for the study
  2. Age < 18 years
  3. Intrauterine pregnancy
  4. Breastfeeding mother
  5. Standard contraindications to ERCP
  6. Allergy/hypersensitivity to aspirin or NSAIDs
  7. Received NSAIDs in prior 7 days (aspirin 325mg or less ok)
  8. Renal failure (Cr >1.4)
  9. Active or recurrent (within 4 weeks) gastrointestinal hemorrhage
  10. Acute pancreatitis (lipase peak) within 72 hours
  11. Known chronic calcific pancreatitis
  12. Pancreatic head mass
  13. Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas divisum (dorsal duct not attempted on injected)
  14. ERCP for biliary stent removal or exchange without anticipated pancreatogram
  15. Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
  16. Anticipated inability to follow protocol
  17. Known active cardiovascular or cerebrovascular disease -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01912716

Contact: Evan L Fogel, MD, MSc, FRCP(C) 317-944-2816

United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Fogel   
Principal Investigator: Evan L Fogel, MD, MSc, FRCP(C)         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Victoria Sheppard    617-667-4046   
Principal Investigator: Ram Chuttani, MD         
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States
Contact: Richard S Kwon, MD         
Principal Investigator: Richard S Kwon, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Badih J Elmunzer, MD         
Principal Investigator: Badih J Elmunzer, MD         
United States, Texas
Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States
Contact: Paul Tarnasky, MD         
Principal Investigator: Paul Tarnasky, MD         
United States, Wisconsin
Aurora St. Lukes' Medical Center Active, not recruiting
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Indiana University
American College of Gastroenterology
University of Michigan
University of Texas
Aurora Health Care
Medical University of South Carolina
Beth Israel Deaconess Medical Center
Principal Investigator: Evan L Fogel, MD, MSc, FRCP(C) Indiana University Health

Responsible Party: Evan Fogel, Professor of Clinical Medicine, Indiana University Identifier: NCT01912716     History of Changes
Other Study ID Numbers: PEP INDO 2013
ACG-CR-002-2013 ( Other Grant/Funding Number: American College of Gastroenterology )
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Keywords provided by Evan Fogel, Indiana University:

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action