Rectal Indomethacin to Prevent Post ESWL-pancreatitis

Phase 4

Completed

• Conditions: Pancreatitis
• Interventions: Drug: indomethacin suppository; Drug: Glycerin Suppository

• Registration Number: NCT02797067
• Lead Sponsor: Changhai Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-05-29
• Study Start: 2016-05-31
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-13
• Primary Completion: 2019-07
• Study Completion: 2021-08
• Results First Submitted: 2021-09-08
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-07
• Last Update Submitted: 2022-03-07
• Results First Posted: 2022-05-26
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1370

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indomethacin	indomethacin suppository	Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.
Glycerin	Glycerin Suppository	Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.

Primary Outcome Measures

Name	Time	Method
the Incidence of Post-ESWL Pancreatitis	up to 1 months	Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase\>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.

Secondary Outcome Measures

Name	Time	Method
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications	up to 1 months	Asymptomatic hyperamylasemia was defined as an increase in serum amylase compared with pre-ESWL levels and beyond the upper limit of the normal range but showing no related symptoms. Serum amylase will be measured in all study patients at 3 and 24 hours after the procedure and subsequently at clinical discretion.; Other post-ESWL complications including bleeding, infection, steinstrasse and perforation.; Bleeding is related to clinical evidence，the level of hemoglobin ( measured at 24 hours after the procedure and at clinical discretion) and treatments.; Infection is related to temperature and treatment. Steinstrasse is related to abdominal pain degree and the combination of other complications.; Perforation is related to treatment.
the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ）	up to 1 months	Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment.

Trial Locations

Locations (1)

Shanghai Changhai Hospital; 🇨🇳 Shanghai, China