Completed

RIPEPRectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)

What is being tested

indomethacin suppository

+ Glycerin Suppository

Drug

Who is being recruted

Chronic Disease+5

+ Digestive System Diseases

+ Pancreatic Diseases

Over 18 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-ControlledPhase 4

Interventional

Study Start: May 2016

See protocol details

Summary

Principal SponsorChanghai Hospital

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 31, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleRectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)

NCT02797067

Principal SponsorChanghai Hospital

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

1370 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseDigestive System DiseasesPancreatic DiseasesPancreatitisPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesPancreatitis, Chronic

Criteria

3 inclusion criteria required to participate

any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL

at least 18 years old

provides informed consent

11 exclusion criteria prevent from participating

readmitted to the hospital during the enrollment of the study

contraindications to ESWL

suspected or established malignancy

pancreatic ascites

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.

Group II

Placebo

Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Shanghai Changhai Hospital

Shanghai, ChinaOpen Shanghai Changhai Hospital in Google Maps

CompletedOne Study Center