Comparison · NCT02116309-sae
Rectal Indomethacin Only vs Rectal Indomethacin Plus Papillary Spray of Epinephrine: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Rectal Indomethacin Only vs Rectal Indomethacin Plus Papillary Spray of Epinephrine: serious adverse events. Trial comparisons, record NCT02116309-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02116309-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00207 | 0.000366 | 0.0117 | wilson | |
| Risk in group 2 | 0.0021 | 0.00037 | 0.0118 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0000217 | -0.00985 | 0.00971 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.99 | 0.0621 | 15.8 | log | |
| Odds ratio, group 1 over group 2 | 0.99 | 0.0617 | 15.9 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rectal Indomethacin Only than on Rectal Indomethacin Plus Papillary Spray of Epinephrine | 46,000 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rectal Indomethacin Only | Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin | 1 | 482 | EG000 |
| Group 2 | Rectal Indomethacin Plus Papillary Spray of Epinephrine | Patients in this group will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.~Rectal Indomethacin~Epinephrine | 1 | 477 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
- NCT number
- NCT02116309
- Phases
- NA
- Conditions
- Post-ERCP Acute Pancreatitis
- Interventions
- Rectal Indomethacin, Epinephrine
- Lead sponsor
- Johns Hopkins University
- Results first posted
- 2017-11-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02116309?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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