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A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis

Sponsor
University of California, San Francisco (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02465138
Collaborator
(none)
0
Enrollment
2
Locations
2
Arms
32
Anticipated Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Determine if IV ketorolac is an effective agent in the prevention of post-ERCP pancreatitis. Determine if IV ketorolac provides improved post-procedure analgesia.

Determine if systemic mediators of inflammation are reduced in patients receiving IV ketorolac following ERCP.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Acute pancreatitis is the most common major complication of both diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity and an annual expenditure of approximately 150 million annually.(1,2) Non-steroidal anti-inflammatory agents (NSAIDs) have been shown to be effective in multiple prospective randomized controlled trial for the prevention of post-ERCP pancreatitis.(3-6) NSAIDs are postulated to inhibit phospholipase A2 and prostaglandin synthesis, which plays an important role in the inflammatory cascade in acute pancreatitis. Rectal suppository indomethacin (a potent COX-2 inhibitor) has been effective in preventing post-ERCP pancreatitis in clinical trials and is now recommended for routine use for ERCP by the European Society of Gastrointestinal Endoscopy.(7) Toradol® (ketorolac), an NSAID available in IV form, is a more potent COX-2 inhibitor and analgesic than indomethacin.(8,9) Ketorolac is routinely used postoperatively following major surgery to assist in pain control particularly following orthopedic procedures. IV ketorolac has never been evaluated for the prevention of post-ERCP pancreatitis.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Normal Saline will be administered prior to procedure.

Drug: Placebo
Intravenous saline
Active Comparator: Toradol

Intravenous ketorolac prior to ERCP

Drug: Ketorolac
Intravenous ketorolac
Other Names:
  • Toradol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events [5 days after ERCP procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients presenting to SFGH for ERCP

    • Age 18-85

    • Do not meet exclusion criteria

    Exclusion Criteria:

    • Acute pancreatitis at the time of ERCP

    • Use of NSAIDs in the previous week

    • Peptic ulcer disease

    • Severe renal dysfunction

    • Pregnancy

    • Lithium therapy

    • allergy to ketorolac

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Francisco General Hospital San Francisco California United States 94117
    2 UCSF/San Francisco General Hospital San Francisco California United States 94132/94110

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: John P Cello, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT02465138
    Other Study ID Numbers:
    • 15-16365
    First Posted:
    Jun 8, 2015
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Pancreatitis
    Ketorolac

    Study Results

    No Results Posted as of Apr 28, 2022