Phase 4 N=1,370 Randomized Triple-blind Prevention

Rectal Indomethacin to Prevent Post ESWL-pancreatitis

Pancreatitis

Bottom Line

View on ClinicalTrials.gov: NCT02797067 ↗

Enrolled (actual)

1,370

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: the Incidence of Post-ESWL Pancreatitis — 60; 84 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: indomethacin suppository (Drug); Glycerin Suppository (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Changhai Hospital
Primary completion: Jul 2019

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	—

Summary

The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02797067). 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.