Trial · NCT02116309
Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
NCT02116309, Not applicable, Completed, Johns Hopkins University; results first posted 2017-11-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis. Trials, record NCT02116309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02116309
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
- NCT number
- NCT02116309
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 948 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Post-ERCP Acute Pancreatitis
- Interventions
- Rectal Indomethacin, Epinephrine
- First posted
- 2014-04-16
- Last updated
- 2017-11-01
- Results first posted
- 2017-11-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Developed Post-ERCP Pancreatitis | 24 hours after ERCP | The primary outcome variable of interest is the incidence of post ERCP pancreatitis (PEP) as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis and 2) amylase or lipase ≥ 3x the upper limit of normal 24 hours after the procedure and 3) Hospitalization or prolongation of existing hospitalization for at least 2 days. |
| Secondary | Number of Patients Who Developed Severe Post-ERCP Pancreatitis | up to 30 days after ERCP | Severity of PEP defined using the consensus grading as Mild PEP that results in hospitalization (or prolongation of existing hospitalization) for ≤3 days. Moderate PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for 4-10 days. Severe PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for \> 10 days, or leads to the development of pancreatic necrosis or pseudocyst, or requires additional endoscopic, percutaneous, or surgical intervention. |
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 | Number of Patients Who Developed Post-ERCP Pancreatitis | 24 hours after ERCP | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Who Developed Severe Post-ERCP Pancreatitis | up to 30 days after ERCP | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number of Patients Who Developed Post-ERCP Pancreatitis | Rectal Indomethacin Only | 31 | Participants | ||
| Number of Patients Who Developed Post-ERCP Pancreatitis | Rectal Indomethacin Plus Papillary Spray of Epinephrine | 32 | Participants | ||
| Number of Patients Who Developed Severe Post-ERCP Pancreatitis | Rectal Indomethacin Only | 4 | Participants | ||
| Number of Patients Who Developed Severe Post-ERCP Pancreatitis | Rectal Indomethacin Plus Papillary Spray of Epinephrine | 7 | 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 | Rectal Indomethacin Only | 482 | |
| Overall Study | STARTED | Rectal Indomethacin Plus Papillary Spray of Epinephrine | 478 | |
| Overall Study | COMPLETED | Rectal Indomethacin Only | 482 | |
| Overall Study | COMPLETED | Rectal Indomethacin Plus Papillary Spray of Epinephrine | 477 | |
| Overall Study | NOT COMPLETED | Rectal Indomethacin Only | 0 | |
| Overall Study | NOT COMPLETED | Rectal Indomethacin Plus Papillary Spray of Epinephrine | 1 |
Source ClinicalTrials.gov
Adverse events6
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 | Hypertension after ERCP | Cardiac disorders | Rectal Indomethacin Only | 34 | 482 | 34 |
| other | Hypertension after ERCP | Cardiac disorders | Rectal Indomethacin Plus Papillary Spray of Epinephrine | 35 | 477 | 35 |
| serious | Arrythmia after ERCP | Cardiac disorders | Rectal Indomethacin Only | 1 | 482 | 1 |
| serious | Arrythmia after ERCP | Cardiac disorders | Rectal Indomethacin Plus Papillary Spray of Epinephrine | 0 | 477 | 0 |
| serious | Post sphincterotomy bleeding | Gastrointestinal disorders | Rectal Indomethacin Only | 0 | 482 | 0 |
| serious | Post sphincterotomy bleeding | Gastrointestinal disorders | Rectal Indomethacin Plus Papillary Spray of Epinephrine | 1 | 477 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rectal Indomethacin Only | 3 | 482 |
| Total, all-cause mortality | Rectal Indomethacin Plus Papillary Spray of Epinephrine | 3 | 477 |
| Total, other adverse events | Rectal Indomethacin Only | 34 | 482 |
| Total, other adverse events | Rectal Indomethacin Plus Papillary Spray of Epinephrine | 35 | 477 |
| Total, serious adverse events | Rectal Indomethacin Only | 1 | 482 |
| Total, serious adverse events | Rectal Indomethacin Plus Papillary Spray of Epinephrine | 1 | 477 |
Source ClinicalTrials.gov
Papers5
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rectal Indomethacin Only vs Rectal Indomethacin Plus Papillary Spray of Epinephrine: Number of Patients Who Developed Severe Post-ERCP Pancreatitis | Trial comparisons |
| Rectal Indomethacin Only vs Rectal Indomethacin Plus Papillary Spray of Epinephrine: Number of Patients Who Developed Post-ERCP Pancreatitis | Trial comparisons |
| Rectal Indomethacin Only vs Rectal Indomethacin Plus Papillary Spray of Epinephrine: deaths from any cause | Trial comparisons |
| Rectal Indomethacin Only vs Rectal Indomethacin Plus Papillary Spray of Epinephrine: 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/NCT02116309
GET https://conductscience.org/api/trials/v1/NCT02116309/registered