Phase 4
Completed N=1,370
Rectal Indomethacin to Prevent Post ESWL-pancreatitis
Source: ClinicalTrials.gov NCT02797067 ↗Enrolled (actual)
1,370
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: the Incidence of Post-ESWL Pancreatitis — 60; 84 Participants
◆ Published Evidence
Established
23citations · ~6 / year
Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial.
Summary
The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis.
Linked Publications (2)
-
Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial.
-
Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Incidence of Post-ESWL Pancreatitis |
60; 84 | — |
| SECONDARY the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications |
5; 13; 0; 1; 0; 1 | — |
| SECONDARY the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ） |
59; 79; 1; 5; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL
- at least 18 years old
- provides informed consent
Exclusion Criteria
- readmitted to the hospital during the enrollment of the study
- contraindications to ESWL
- suspected or established malignancy
- pancreatic ascites
- receiving NSAIDs within 7 days
- contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or renal dysfunction with serum creatinine >120 μmol/L)
- presence of coagulopathy or received anticoagulation therapy within 3 days
- acute pancreatitis within 3 days
- known active cardiovascular or cerebrovascular disease
- pregnant or breastfeeding women
- without a rectum (ie, status post-total proctocolectomy)
Data sourced from ClinicalTrials.gov (NCT02797067) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.