A Randomized Controlled Trial of IV Ketorolac to Prevent... | NCT02465138

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

NCT02465138

Sponsor

University of California, San Francisco

Status

Withdrawn

Last Update Posted

Apr 28, 2022Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Pancreatitis

Interventions

Ketorolac
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of Funding

Expanded Access Info

Start Date

Nov 2023Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Mar 25, 2015

First Submission Date that Met QC Criteria

Jun 3, 2015

First Posted Date

Jun 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2022

Last Update Posted Date

Apr 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Normal Saline will be administered prior to procedure.	Drug: Placebo
Toradol	Active Comparator	Intravenous ketorolac prior to ERCP	Drug: Ketorolac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ketorolac	Drug	Intravenous ketorolac	Toradol	Toradol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events		5 days after ERCP procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Francisco General Hospital		San Francisco	California	94117	United States
UCSF/San Francisco General Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15173799	Background	Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc. 2004 Jun;59(7):845-64. doi: 10.1016/s0016-5107(04)00353-0. No abstract available.
8782497	Background	Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

ID	Term
D020910	Ketorolac
D020911	Ketorolac Tromethamine

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring