Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)
Overview
- Phase
- Phase 4
- Intervention
- indomethacin suppository
- Conditions
- Pancreatitis
- Sponsor
- Changhai Hospital
- Enrollment
- 1370
- Locations
- 1
- Primary Endpoint
- the Incidence of Post-ESWL Pancreatitis
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Zhuan Liao
Professor
Changhai Hospital
Eligibility Criteria
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
Arms & Interventions
Indomethacin
Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.
Intervention: indomethacin suppository
Glycerin
Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.
Intervention: Glycerin Suppository
Outcomes
Primary Outcomes
the Incidence of Post-ESWL Pancreatitis
Time Frame: 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 Outcomes
- the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications(up to 1 months)
- the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ）(up to 1 months)