Trial · NCT02476279

Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis

NCT02476279, Phase 3, Completed, Medical University of South Carolina; results first posted 2024-05-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis. Trials, record NCT02476279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02476279

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis
NCT number: NCT02476279
Status: Completed
Phases: Phase 3
Enrollment: 1,950 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Post-ERCP Pancreatitis
Interventions: Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement, Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
First posted: 2015-06-19
Last updated: 2024-06-12
Results first posted: 2024-05-08
Limitations and caveats: Potential unmasking events occurred and could have influenced care. Decay in secondary outcome blinding, as unblinded clinician could resume care of patient after 48 h. Adjudicators provided radiographic information when assessing PEP severity, which may have influenced decision making. Unblinded endoscopists made procedural decisions, possibly altered according to study arm. Findings may not be applicable to community endoscopists since all sites were tertiary referral centers.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis	Within 48 hours after ERCP	Post-ERCP pancreatitis (PEP) was based on a widely validated consensus definition that was applied as a diagnostic framework. In this consensus definition, PEP is diagnosed if there was new onset (or increase) of pain in the upper abdomen, elevation in pancreatic enzymes of at least three times the upper limit of normal 24 h after the procedure, and hospitalization for at least two nights. The outcome was independently adjudicated by 3 ERCP experts at non-enrolling centers based on review of the medical records for study participants who were hospitalized with any adverse event within 2 days of the ERCP. Medical records were redacted of all information that could potentially reveal study group assignment, including radiology reports. The consensus definition was applied as a diagnostic framework so that adjudicators could use their best judgment in cases that did not strictly satisfy the criteria. PEP was declared if there was agreement between at least two of the three adjudicators.
Secondary	The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis	Within one month of ERCP	Moderate or severe post-ERCP pancreatitis was based on the consensus definition as a diagnostic framework. For the severity assessment, radiographic information was made available to the adjudicators. The severity was defined as mild post-ERCP pancreatitis resulting in a hospitalization of ≤3 days, moderate post-ERCP pancreatitis resulting in a hospitalization of 4-10 days, and severe post-ERCP pancreatitis resulting in a hospitalization of \> 10 days, or leading to the development of pancreatic necrosis or pseudocyst, or requiring percutaneous or surgical intervention. The outcome was declared if there was agreement between at least two of the three adjudicators.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis	Within 48 hours after ERCP	Intention-To-Treat and Per Protocol populations	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis	Within one month of ERCP	Intention-to-treat and per protocol. Outcome data missing for two participants (one in each treatment arm) and excluded from percentage denominator.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis	Indomethacin Alone	Intention-To-Treat Population	145	Participants
The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis	Indomethacin+Pancreatic Stent	Intention-To-Treat Population	110	Participants
The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis	Indomethacin Alone	Per Protocol Population	137	Participants
The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis	Indomethacin+Pancreatic Stent	Per Protocol Population	90	Participants
The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis	Indomethacin Alone	Intention-to-treat population	78	Participants
The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis	Indomethacin+Pancreatic Stent	Intention-to-treat population	58	Participants
The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis	Indomethacin Alone	Per protocol population	74	Participants
The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis	Indomethacin+Pancreatic Stent	Per protocol population	45	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Indomethacin Alone	975
Overall Study	STARTED	Indomethacin+Pancreatic Stent	975
Overall Study	COMPLETED	Indomethacin Alone	974
Overall Study	COMPLETED	Indomethacin+Pancreatic Stent	974
Overall Study	NOT COMPLETED	Indomethacin Alone	1
Overall Study	NOT COMPLETED	Indomethacin+Pancreatic Stent	1

Source ClinicalTrials.gov

Adverse events450

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	Indomethacin Alone	185	975	187
other	Abdominal pain	Gastrointestinal disorders	Indomethacin+Pancreatic Stent	188	975	189
other	Abdominal pain upper	Gastrointestinal disorders	Indomethacin Alone	6	975	6
other	Abdominal pain upper	Gastrointestinal disorders	Indomethacin+Pancreatic Stent	3	975	3
other	Constipation	Gastrointestinal disorders	Indomethacin Alone	2	975	2
other	Constipation	Gastrointestinal disorders	Indomethacin+Pancreatic Stent	5	975	5
other	Diarrhoea	Gastrointestinal disorders	Indomethacin Alone	8	975	8
other	Diarrhoea	Gastrointestinal disorders	Indomethacin+Pancreatic Stent	6	975	6
other	Nausea	Gastrointestinal disorders	Indomethacin Alone	24	975	25
other	Nausea	Gastrointestinal disorders	Indomethacin+Pancreatic Stent	18	975	18

1 to 10 of 450Source ClinicalTrials.gov

See all 450 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Indomethacin Alone	24	975
Total, all-cause mortality	Indomethacin+Pancreatic Stent	26	975
Total, other adverse events	Indomethacin Alone	233	975
Total, other adverse events	Indomethacin+Pancreatic Stent	228	975
Total, serious adverse events	Indomethacin Alone	355	975
Total, serious adverse events	Indomethacin+Pancreatic Stent	352	975

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26941086	DERIVED	PubMed
38219767	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DK104833	Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI Trial	ELMUNZER, BADIH JOSEPH	MEDICAL UNIVERSITY OF SOUTH CAROLINA	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2015 to 2020

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Indomethacin Alone vs Indomethacin+Pancreatic Stent: deaths from any cause	Trial comparisons
Indomethacin Alone vs Indomethacin+Pancreatic Stent: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02476279

GET https://conductscience.org/api/trials/v1/NCT02476279/events?page=2

API reference For AI assistants