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Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

This study has been terminated.
(Futility)
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01774604
First received: January 21, 2013
Last updated: September 28, 2016
Last verified: September 2016
  Purpose
The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.

Condition Intervention Phase
Post-ERCP Acute Pancreatitis
Drug: Indomethacin
Drug: Placebo
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 to Prevent Post-ERCP Pancreatitis

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Number of Patients Who Developed Acute Pancreatitis [ Time Frame: From randomization to 30 days after ERCP ] [ Designated as safety issue: Yes ]
    Number of patients who developed pancreatitis following ERCP based on Atlanta Classification


Secondary Outcome Measures:
  • Number of Patients Who Developed Severe Pancreatitis [ Time Frame: From randomization to 30 days after ERCP ] [ Designated as safety issue: Yes ]
    Number of patients with severe acute pancreatitis based on the Atlanta Classification

  • Number of Patients Who Developed Moderately Severe Pancreatitis [ Time Frame: From randomization to 30 days after ERCP ] [ Designated as safety issue: Yes ]
    Number of patients with moderately severe pancreatitis based on Atlanta Classification

  • Number of Patients Who Developed Mild Pancreatitis [ Time Frame: From randomization to 30 days after ERCP ] [ Designated as safety issue: Yes ]
    Number of patient who developed mild acute pancreatitis based on the Atlanta Classification

  • Number of Patients Who Developed Gastrointestinal Bleeding [ Time Frame: From randomization to 30 days after ERCP ] [ Designated as safety issue: Yes ]
    Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure

  • Number of Patient Deaths [ Time Frame: From randomization to 30 days after ERCP ] [ Designated as safety issue: Yes ]
    Number of patients who died from any cause from the time of ERCP until 30 days post-procedure

  • Number of Patients With 30 Days Hospital Re-admission [ Time Frame: From randomization until 30 days after ERCP ] [ Designated as safety issue: Yes ]
    Number of patients admitted to the hospital for any cause following ERCP


Enrollment: 449
Study Start Date: January 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indomethacin
Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period
Drug: Indomethacin
100 mg Indomethacin PR x 1
Placebo Comparator: Placebo
Placebo suppositories (#2)
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Scheduled for an ERCP at Dartmouth-Hitchcock
  2. Age greater than 18 years old
  3. Ability to provide written informed consent

Exclusion Criteria:

  1. Inability to provide written informed consent
  2. ERCP being performed for diagnosis and/or treatment of acute pancreatitis
  3. Current ongoing acute pancreatitis
  4. Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
  5. Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)
  6. Pregnant or nursing mothers
  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: NCT01774604

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: John M Levenick, MD Dartmouth-Hitchcock Medical Center
  More Information

Publications:
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01774604     History of Changes
Other Study ID Numbers: CPHS#23749 
Study First Received: January 21, 2013
Results First Received: July 29, 2016
Last Updated: September 28, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Post ERCP acute pancreatitis
Post Fine Needle Aspiration (FNA) acute pancreatitis
Indomethacin
Rectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)

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
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016