Trial record 51 of 70 for:    gastroenterology | Recruiting | Exclude Unknown | United States

Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Indiana University
Sponsor:
Collaborators:
American College of Gastroenterology
University of Michigan
University of Texas
Aurora Health Care
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01912716
First received: July 29, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Post-ERCP Pancreatitis
Drug: high dose indomethacin
Other: standard dose
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • frequency of pancreatitis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • severity of pancreatitis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1036
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high-dose indomethacin Drug: high dose indomethacin
Active Comparator: standard dose indomethacin Other: standard dose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 of any sphincter
  6. Pneumatic dilation of intact biliary sphincter
  7. Ampullectomy

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912716

Contacts
Contact: Evan L Fogel, MD, MSc, FRCP(C) 317-944-2816 efogel@iu.edu

Locations
United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Fogel       efogel@iu.edu   
Principal Investigator: Evan L Fogel, MD, MSc, FRCP(C)         
United States, Michigan
University of Michigan Medical Center Not yet recruiting
Ann Arbor, Michigan, United States
Contact: Badih J Elmunzer, MD         
Principal Investigator: Badih J Elmunzer, MD         
United States, Texas
Methodist Dallas Medical Center Not yet recruiting
Dallas, Texas, United States
Contact: Paul Tarnasky, MD         
Principal Investigator: Paul Tarnasky, MD         
United States, Wisconsin
Aurora St. Lukes' Medical Center Not yet recruiting
Milwaukee, Wisconsin, United States
Contact: Nalini Guda, MD         
Principal Investigator: Nalini Guda, MD         
Sponsors and Collaborators
Indiana University
American College of Gastroenterology
University of Michigan
University of Texas
Aurora Health Care
Investigators
Principal Investigator: Evan L Fogel, MD, MSc, FRCP(C) Indiana University Health
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01912716     History of Changes
Other Study ID Numbers: PEP INDO 2013, ACG-CR-002-2013
Study First Received: July 29, 2013
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
pancreatitis
ERCP

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

ClinicalTrials.gov processed this record on October 19, 2014