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Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01774604
Recruitment Status : Terminated (Futility)
First Posted : January 24, 2013
Results First Posted : September 20, 2016
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE January 21, 2013
First Posted Date  ICMJE January 24, 2013
Results First Submitted Date  ICMJE July 29, 2016
Results First Posted Date  ICMJE September 20, 2016
Last Update Posted Date November 4, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
Number of Patients Who Developed Acute Pancreatitis [ Time Frame: From randomization to 30 days after ERCP ]
Number of patients who developed pancreatitis following ERCP based on Atlanta Classification
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
Rate of post-ERCP pancreatitis in all patients [ Time Frame: 30 days ]
Assess whether rectal indomethacin, compared to placebo, will lower the rate of post-ERCP pancreatitis in all patients
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
  • Number of Patients Who Developed Severe Pancreatitis [ Time Frame: From randomization to 30 days after ERCP ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Number of patients admitted to the hospital for any cause following ERCP
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
  • Severity of post-ERCP pancreatitis [ Time Frame: 30 days ]
    Assess the difference in severity of post-ERCP pancreatitis in patients who develop this condition
  • Post-fine needle aspiration pancreatitis in setting of concomitant ERCP/EUS [ Time Frame: 30 days ]
    Assess the rates of post-fine needle aspiration (FNA) pancreatitis in the setting of concomitant ERCP/endoscopic ultrasound examinations
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Official Title  ICMJE Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Post-ERCP Acute Pancreatitis
Intervention  ICMJE
  • Drug: Indomethacin
    100 mg Indomethacin PR x 1
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Indomethacin
    Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period
    Intervention: Drug: Indomethacin
  • Placebo Comparator: Placebo
    Placebo suppositories (#2)
    Intervention: Drug: Placebo
Publications * Levenick JM, Gordon SR, Fadden LL, Levy LC, Rockacy MJ, Hyder SM, Lacy BE, Bensen SP, Parr DD, Gardner TB. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology. 2016 Apr;150(4):911-7; quiz e19. doi: 10.1053/j.gastro.2015.12.040. Epub 2016 Jan 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 25, 2015)
449
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2013)
1398
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01774604
Other Study ID Numbers  ICMJE CPHS#23749
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John M Levenick, MD Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP