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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-ERCP Pancreatitis | 30 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. |
| Secondary | Moderate-to-severe Pancreatitis | 30 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). |
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 | Post-ERCP Pancreatitis | 30 days | participants | NUMBER | |
| SECONDARY | Moderate-to-severe Pancreatitis | 30 days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Post-ERCP Pancreatitis | Pre-ERCP Group | 47 | participants | ||
| Post-ERCP Pancreatitis | Post-ERCP Group | 100 | participants | ||
| Moderate-to-severe Pancreatitis | Pre-ERCP Group | 11 | participants | ||
| Moderate-to-severe Pancreatitis | Post-ERCP Group | 23 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pre-ERCP Group | 1,297 | |
| Overall Study | STARTED | Post-ERCP Group | 1,303 | |
| Overall Study | COMPLETED | Pre-ERCP Group | 1,297 | |
| Overall Study | COMPLETED | Post-ERCP Group | 1,303 | |
| Overall Study | NOT COMPLETED | Pre-ERCP Group | 0 | |
| Overall Study | NOT COMPLETED | Post-ERCP Group | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Mild bleeding | Gastrointestinal disorders | Pre-ERCP Group | 5 | 1,297 | 5 |
| other | Mild bleeding | Gastrointestinal disorders | Post-ERCP Group | 4 | 1,303 | 4 |
| other | Mild biliary infection | Infections and infestations | Pre-ERCP Group | 15 | 1,297 | 15 |
| other | Mild biliary infection | Infections and infestations | Post-ERCP Group | 24 | 1,303 | 24 |
| other | Mild perforation | Gastrointestinal disorders | Pre-ERCP Group | 1 | 1,297 | 1 |
| other | Mild perforation | Gastrointestinal disorders | Post-ERCP Group | 0 | 1,303 | 0 |
| other | Pulmonary infection | Infections and infestations | Pre-ERCP Group | 2 | 1,297 | 2 |
| other | Pulmonary infection | Infections and infestations | Post-ERCP Group | 5 | 1,303 | 5 |
| other | Incomplete bowel obstruction | Gastrointestinal disorders | Pre-ERCP Group | 3 | 1,297 | 3 |
| other | Incomplete bowel obstruction | Gastrointestinal disorders | Post-ERCP Group | 0 | 1,303 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-ERCP Group | ||
| Total, all-cause mortality | Post-ERCP Group | ||
| Total, other adverse events | Pre-ERCP Group | 26 | 1,297 |
| Total, other adverse events | Post-ERCP Group | 33 | 1,303 |
| Total, serious adverse events | Pre-ERCP Group | 15 | 1,297 |
| Total, serious adverse events | Post-ERCP Group | 15 | 1,303 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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.
| Comparison | Source |
|---|---|
| Pre-ERCP Group vs Post-ERCP Group: Moderate-to-severe Pancreatitis | Trial comparisons |
| Pre-ERCP Group vs Post-ERCP Group: Post-ERCP Pancreatitis | Trial comparisons |
| Pre-ERCP Group vs Post-ERCP Group: 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.
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