Rectal Indomethacin to Prevent Post ESWL-pancreatitis (RIPEP)

Naval Military Medical University

Status and phase

Completed

Phase 4

Conditions

Pancreatitis

Treatments

Drug: Glycerin Suppository

Drug: indomethacin suppository

Study type

Interventional

Funder types

Other

Identifiers

NCT02797067

ESWL-pancreatitis

Details and patient eligibility

About

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

Full description

It is a prospective, double-blind, randomized controlled trial. Patients with painful chronic pancreatitis and pancreatic stones (> 5 mm in diameter) who are treated with ESWL at Changhai Hospital will be randomly allocated to indomethacin or placebo therapy before the procedure.

Enrollment

1,370 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)