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

Primary Purpose

Post-ERCP Acute Pancreatitis

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Indomethacin

Placebo

About this trial

This is an interventional prevention trial for Post-ERCP Acute Pancreatitis focused on measuring Post ERCP acute pancreatitis, Post Fine Needle Aspiration (FNA) acute pancreatitis, Indomethacin, Rectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)

Eligibility Criteria

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

Inclusion Criteria:

Scheduled for an ERCP at Dartmouth-Hitchcock
Age greater than 18 years old
Ability to provide written informed consent

Exclusion Criteria:

Inability to provide written informed consent
ERCP being performed for diagnosis and/or treatment of acute pancreatitis
Current ongoing acute pancreatitis
Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)
Pregnant or nursing mothers

Sites / Locations

Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Indomethacin

Placebo

Arm Description

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

Placebo suppositories (#2)

Outcomes

Primary Outcome Measures

Number of Patients Who Developed Acute Pancreatitis

Number of patients who developed pancreatitis following ERCP based on Atlanta Classification

Secondary Outcome Measures

Number of Patients Who Developed Severe Pancreatitis

Number of patients with severe acute pancreatitis based on the Atlanta Classification

Number of Patients Who Developed Moderately Severe Pancreatitis

Number of patients with moderately severe pancreatitis based on Atlanta Classification

Number of Patients Who Developed Mild Pancreatitis

Number of patient who developed mild acute pancreatitis based on the Atlanta Classification

Number of Patients Who Developed Gastrointestinal Bleeding

Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure

Number of Patient Deaths

Number of patients who died from any cause from the time of ERCP until 30 days post-procedure

Number of Patients With 30 Days Hospital Re-admission

Number of patients admitted to the hospital for any cause following ERCP

Full Information

NCT ID

NCT01774604

First Posted

January 21, 2013

Last Updated

September 28, 2016

Sponsor

Dartmouth-Hitchcock Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01774604

Brief Title

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

Official Title

Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Why Stopped

Futility

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Post-ERCP Acute Pancreatitis

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

449 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Indomethacin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo suppositories (#2)

Intervention Type

Drug

Intervention Name(s)

Indomethacin

Intervention Description

100 mg Indomethacin PR x 1

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Number of Patients Who Developed Acute Pancreatitis

Description

Number of patients who developed pancreatitis following ERCP based on Atlanta Classification

Time Frame

From randomization to 30 days after ERCP

Secondary Outcome Measure Information:

Title

Number of Patients Who Developed Severe Pancreatitis

Description

Number of patients with severe acute pancreatitis based on the Atlanta Classification

Time Frame

From randomization to 30 days after ERCP

Title

Number of Patients Who Developed Moderately Severe Pancreatitis

Description

Number of patients with moderately severe pancreatitis based on Atlanta Classification

Time Frame

From randomization to 30 days after ERCP

Title

Number of Patients Who Developed Mild Pancreatitis

Description

Number of patient who developed mild acute pancreatitis based on the Atlanta Classification

Time Frame

From randomization to 30 days after ERCP

Title

Number of Patients Who Developed Gastrointestinal Bleeding

Description

Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure

Time Frame

From randomization to 30 days after ERCP

Title

Number of Patient Deaths

Description

Number of patients who died from any cause from the time of ERCP until 30 days post-procedure

Time Frame

From randomization to 30 days after ERCP

Title

Number of Patients With 30 Days Hospital Re-admission

Description

Number of patients admitted to the hospital for any cause following ERCP

Time Frame

From randomization until 30 days after ERCP

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Scheduled for an ERCP at Dartmouth-Hitchcock Age greater than 18 years old Ability to provide written informed consent Exclusion Criteria: Inability to provide written informed consent ERCP being performed for diagnosis and/or treatment of acute pancreatitis Current ongoing acute pancreatitis Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection) Pregnant or nursing mothers

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John M Levenick, MD

Organizational Affiliation

Dartmouth-Hitchcock Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dartmouth-Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26775631

Citation

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.

Results Reference

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

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