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TerminatedNCT01774604Updated Nov 4, 2016Results posted

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

A Phase 3 interventional study of Indomethacin and Placebo in Post-ERCP Acute Pancreatitis, sponsored by Dartmouth-Hitchcock Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-04.

Sponsored by Dartmouth-Hitchcock Medical Center · Phase 3, Interventional, and Prevention

Why this study was terminated
Futility
Phase
Phase 3
Study type
Interventional
Enrollment
449
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Post-ERCP Acute Pancreatitis

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Keywords

  • Post ERCP acute pancreatitis
  • Post Fine Needle Aspiration (FNA) acute pancreatitis
  • Indomethacin
  • Rectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)
03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 449 is above the median of 80 across 448 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
449 participants (actual)

Study arms

  • Experimental
    Indomethacin

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

    Drug: Indomethacin

  • Placebo comparator
    Placebo

    Placebo suppositories (#2)

    Drug: Placebo

Interventions

  • DrugIndomethacin

    100 mg Indomethacin PR x 1

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Number of Patients Who Developed Acute Pancreatitis

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

    Time frame: From randomization to 30 days after ERCP

Secondary outcomes

  1. Number of Patients Who Developed Severe Pancreatitis

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

    Time frame: From randomization to 30 days after ERCP

  2. Number of Patients Who Developed Moderately Severe Pancreatitis

    Number of patients with moderately severe pancreatitis based on Atlanta Classification

    Time frame: From randomization to 30 days after ERCP

  3. Number of Patients Who Developed Mild Pancreatitis

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

    Time frame: From randomization to 30 days after ERCP

  4. 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

    Time frame: From randomization to 30 days after ERCP

  5. Number of Patient Deaths

    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

  6. Number of Patients With 30 Days Hospital Re-admission

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

    Time frame: From randomization until 30 days after ERCP

07

Results

Posted Sep 20, 2016
Limitations and caveats
The study was terminated due to indomethacin's lack of efficacy after 449 patients had been enrolled. Thus the study may be underpowered to draw conclusions about the role of indomethacin in preventing post ERCP pancreatitis

Participant flow

All patients who presented to Dartmouth-Hitchcock Medical Center for Endoscopic Retrograde Cholangiopancreatography (ERCP) for any reason between March 2013 and December 2014

Participant flow — Overall Study
MilestoneIndomethacinPlacebo
Started223226
Completed223226
Not completed00

Outcome measures

PrimaryNumber of Patients Who Developed Acute Pancreatitis

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

Time frame:
From randomization to 30 days after ERCP
Reported as:
Number · participants
Number of Patients Who Developed Acute Pancreatitis
participantsIndomethacinPlacebo
Number of Patients Who Developed Acute Pancreatitis1611
Statistical analysis
  • Indomethacin vs Placebo · Fisher Exact · p = 0.33
SecondaryNumber of Patients Who Developed Severe Pancreatitis

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

Time frame:
From randomization to 30 days after ERCP
Reported as:
Number · participants
Number of Patients Who Developed Severe Pancreatitis
participantsIndomethacinPlacebo
Number of Patients Who Developed Severe Pancreatitis01
Statistical analysis
  • Indomethacin vs Placebo · Fisher Exact · p = 1.00
SecondaryNumber of Patients Who Developed Moderately Severe Pancreatitis

Number of patients with moderately severe pancreatitis based on Atlanta Classification

Time frame:
From randomization to 30 days after ERCP
Reported as:
Number · participants
Number of Patients Who Developed Moderately Severe Pancreatitis
participantsIndomethacinPlacebo
Number of Patients Who Developed Moderately Severe Pancreatitis01
Statistical analysis
  • Indomethacin vs Placebo · Fisher Exact · p = 1.00
SecondaryNumber of Patients Who Developed Mild Pancreatitis

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

Time frame:
From randomization to 30 days after ERCP
Reported as:
Number · participants
Number of Patients Who Developed Mild Pancreatitis
participantsIndomethacinPlacebo
Number of Patients Who Developed Mild Pancreatitis169
Statistical analysis
  • Indomethacin vs Placebo · Fisher Exact · p = 0.15
SecondaryNumber 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

Time frame:
From randomization to 30 days after ERCP
Reported as:
Number · participants
Number of Patients Who Developed Gastrointestinal Bleeding
participantsIndomethacinPlacebo
Number of Patients Who Developed Gastrointestinal Bleeding46
Statistical analysis
  • Indomethacin vs Placebo · Fisher Exact · p = 0.75
SecondaryNumber of Patient Deaths

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
Reported as:
Number · participants
Number of Patient Deaths
participantsIndomethacinPlacebo
Number of Patient Deaths03
Statistical analysis
  • Indomethacin vs Placebo · Fisher Exact · p = 0.25
SecondaryNumber of Patients With 30 Days Hospital Re-admission

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

Time frame:
From randomization until 30 days after ERCP
Reported as:
Number · participants
Number of Patients With 30 Days Hospital Re-admission
participantsIndomethacinPlacebo
Number of Patients With 30 Days Hospital Re-admission3120
Statistical analysis
  • Indomethacin vs Placebo · Fisher Exact · p = 0.10

Adverse events

Collected over From randomization to 30 days after ERCP. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Indomethacin—0/223 (0%)4/223 (1.8%)
Placebo—3/226 (1.3%)6/226 (2.7%)
Most frequent serious events
Most frequent serious events
EventIndomethacinPlacebo
Severe Acute Pancreatitis Leading to DeathGastrointestinal disorders0/2231/226
Secondary Bacterial Peritonitis due to Multifocal Hepatocellular Carcinoma Leading to DeathGastrointestinal disorders0/2231/226
Aspiration Post-Procedure Leading to DeathRespiratory, thoracic and mediastinal disorders0/2231/226
Most frequent other events
Most frequent other events
EventIndomethacinPlacebo
Gastrointestinal BleedingGastrointestinal disorders4/2236/226

Baseline characteristics

All patient randomized to receive rectal indomethacin or placebo

Age, Continuous
Age, Continuous(years)IndomethacinPlaceboTotal
Mean64.9 ± 23.764.3 ± 15.164.6 ± 19.9
Sex: Female, Male
Sex: Female, Male(Participants)IndomethacinPlaceboTotal
Female118118236
Male105108213
Indication
Indication(participants)IndomethacinPlaceboTotal
Acute Cholangitis121325
Choledocholithiasis5952111
Malignant Biliary Obstruction5350103
Biliary Stent Change252550
Biliary Leak111223
Increased Liver Tests/Jaundice13922
Pancreatic Stricture358
Suspected Sphincter of Oddi Dysfunction (SOD)6814
Pancreatic Leak/Disruption111223
Pancreatic Duct Stone325
Recurrent Acute Pancreatitis527
Ampullectomy6511
Other163147
History of post-ERCP Pancreatitis
History of post-ERCP Pancreatitis(participants)IndomethacinPlaceboTotal
Yes9918
No214217431
History of Previous Sphincterotomy
History of Previous Sphincterotomy(participants)IndomethacinPlaceboTotal
Yes7271143
No151155306
Previous ERCP
Previous ERCP(participants)IndomethacinPlaceboTotal
Yes8179160
No142147289
Difficult Cannulation
Difficult Cannulation(participants)IndomethacinPlaceboTotal
Yes464288
No177184361
Precut Biliary Sphincterotomy
Precut Biliary Sphincterotomy(participants)IndomethacinPlaceboTotal
Yes111627
No212210422

12 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
09

References and documents

Publications

  • 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. PubMed 26775631 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01774604
Lead sponsor
Dartmouth-Hitchcock Medical Center
Responsible party
Sponsor
First posted
Jan 24, 2013
Start date
Jan 2013
Primary completion
Dec 2014
Completion
Dec 2014
Results posted
Sep 20, 2016
Last update
Nov 4, 2016

Study contacts

John M Levenick, MD
principal investigator · Dartmouth-Hitchcock Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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