Rectal Indomethacin to Prevent Post ESWL-pancreatitis

Changhai Hospital1,370 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,370

Conditions

Pancreatitis

Interventions

indomethacin suppositoryDRUG

100mg rectal indomethacin 30min before ESWL

Glycerin SuppositoryDRUG

30min before ESWL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Shanghai Changhai Hospital

Shanghai, China

Outcomes

Primary Outcomes

the Incidence of Post-ESWL Pancreatitis

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.

Time frame: up to 1 months

Secondary Outcomes

the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications

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.

Time frame: up to 1 months

the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ）

Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment.

Time frame: up to 1 months

Data from ClinicalTrials.gov

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