Rectal Indomethacin to Prevent Post ESWL-pancreatitis

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

Detailed Description
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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 Title
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Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)

Conditions
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Pancreatitis

Intervention / Treatment
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* Drug: indomethacin suppository
* Drug: Glycerin Suppository


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indomethacin<br>Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. | Drug: indomethacin suppository<br>* 100mg rectal indomethacin 30min before ESWL<br>|
| Placebo Comparator: Glycerin<br>Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL. | Drug: Glycerin Suppository<br>* 30min before ESWL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 1 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal Shock Wave lithotripsy(ESWL), Prophylaxis, Indomethacin, Chronic pancreatitis