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Trial · NCT02002650

Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

NCT02002650, Not applicable, Completed, Air Force Military Medical University, China; results first posted 2016-05-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Rectal Indomethacin to Prevent Post-ERCP Pancreatitis. Trials, record NCT02002650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02002650

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Trial

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

Title
Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
NCT number
NCT02002650
Status
Completed
Phases
Not applicable
Enrollment
2,600 participants, actual
Lead sponsor
Air Force Military Medical University, China
Conditions
Post-ERCP Acute Pancreatitis
Interventions
Pre-ERCP rectal Indomethacin, Post-operational Rectal Indomethacin
First posted
2013-12-06
Last updated
2016-06-29
Results first posted
2016-05-27
Limitations and caveats
Firstly, patients could not be blinded to the treatment assignment. Secondly, it remains unclear if patients with prior EST will benefit from rectal indomethacin. Thirdly, the findings need to be validated in different clinical settings.

Source ClinicalTrials.gov

Registered outcomes2

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

ListOutcomeTime frameDescription
PrimaryPost-ERCP Pancreatitis30 days
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.
SecondaryModerate-to-severe Pancreatitis30 days
Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).

Outcomes2

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPost-ERCP Pancreatitis30 daysparticipantsNUMBER
SECONDARYModerate-to-severe Pancreatitis30 daysparticipantsNUMBER

Results by group4

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

OutcomeGroupCategoryValueSpreadUnits
Post-ERCP PancreatitisPre-ERCP Group47participants
Post-ERCP PancreatitisPost-ERCP Group100participants
Moderate-to-severe PancreatitisPre-ERCP Group11participants
Moderate-to-severe PancreatitisPost-ERCP Group23participants

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPre-ERCP Group1,297
Overall StudySTARTEDPost-ERCP Group1,303
Overall StudyCOMPLETEDPre-ERCP Group1,297
Overall StudyCOMPLETEDPost-ERCP Group1,303
Overall StudyNOT COMPLETEDPre-ERCP Group0
Overall StudyNOT COMPLETEDPost-ERCP Group0

Adverse events14

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherMild bleedingGastrointestinal disordersPre-ERCP Group51,2975
otherMild bleedingGastrointestinal disordersPost-ERCP Group41,3034
otherMild biliary infectionInfections and infestationsPre-ERCP Group151,29715
otherMild biliary infectionInfections and infestationsPost-ERCP Group241,30324
otherMild perforationGastrointestinal disordersPre-ERCP Group11,2971
otherMild perforationGastrointestinal disordersPost-ERCP Group01,3030
otherPulmonary infectionInfections and infestationsPre-ERCP Group21,2972
otherPulmonary infectionInfections and infestationsPost-ERCP Group51,3035
otherIncomplete bowel obstructionGastrointestinal disordersPre-ERCP Group31,2973
otherIncomplete bowel obstructionGastrointestinal disordersPost-ERCP Group01,3030

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPre-ERCP Group
Total, all-cause mortalityPost-ERCP Group
Total, other adverse eventsPre-ERCP Group261,297
Total, other adverse eventsPost-ERCP Group331,303
Total, serious adverse eventsPre-ERCP Group151,297
Total, serious adverse eventsPost-ERCP Group151,303

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
22494121RESULTPubMed
23164513RESULTPubMed
27133971DERIVEDPubMed

Grants0

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.

None in this release.

Trial comparisons3

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

ComparisonSource
Pre-ERCP Group vs Post-ERCP Group: Moderate-to-severe PancreatitisTrial comparisons
Pre-ERCP Group vs Post-ERCP Group: Post-ERCP PancreatitisTrial comparisons
Pre-ERCP Group vs Post-ERCP Group: serious adverse eventsTrial 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/NCT02002650

GET https://conductscience.org/api/trials/v1/NCT02002650/registered