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Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

NCT ID: NCT01774604

Last Updated: 2016-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

449 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Post-ERCP Acute Pancreatitis

Keywords

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Post ERCP acute pancreatitis Post Fine Needle Aspiration (FNA) acute pancreatitis Indomethacin Rectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Indomethacin

Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period

Group Type EXPERIMENTAL

Indomethacin

Intervention Type DRUG

100 mg Indomethacin PR x 1

Placebo

Placebo suppositories (#2)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Indomethacin

100 mg Indomethacin PR x 1

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John M Levenick, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26775631 (View on PubMed)

Other Identifiers

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CPHS#23749

Identifier Type: -

Identifier Source: org_study_id