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

Primary Purpose

Pancreatitis

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatitis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco General Hospital
  • UCSF/San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Toradol

Arm Description

Normal Saline will be administered prior to procedure.

Intravenous ketorolac prior to ERCP

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Secondary Outcome Measures

Full Information

First Posted
March 25, 2015
Last Updated
April 21, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02465138
Brief Title
A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis
Official Title
A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of Funding
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal Saline will be administered prior to procedure.
Arm Title
Toradol
Arm Type
Active Comparator
Arm Description
Intravenous ketorolac prior to ERCP
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
Intravenous ketorolac
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous saline
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
5 days after ERCP procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Cello, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
UCSF/San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94132/94110
Country
United States

12. IPD Sharing Statement

Citations:
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15173799
Citation
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Citation
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A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis

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