Expired Study
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San Francisco, California


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02465138


Primary Contact:

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

John P Cello, MD
Phone: 415-206-4767
Email: john.cello@ucsf.edu


Backup Contact:

Email: stan.rogers@ucsf.edu
Stanley J Rogers, MD
Phone: 415-476-0762


Location Contact:

San Francisco, California
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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