Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Not Applicable

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Interventions: Drug: Allopurinol

• Registration Number: NCT02992652
• Lead Sponsor: Ain Shams University

Brief Summary

* The investigators evaluated the role of allopurinol in prevention of post-ERCP pancreatitis.

* 100 Egyptian patients who were candidates for ERCP were included and divided into two groups. Group 1 (study group) included 50 patients who received two doses of allopurinol 300 mg each, 15 hours and 3 hours before ERCP and Group 2 (control group) included 50 patients who did not receive allopurinol prophylaxis.

Detailed Description

A diagnosis of procedure-related pancreatitis was based on an increased serum amylase level greater than three times the upper normal limits, associated with abdominal pain requiring analgesics and persisting for at least 24 hours after the procedure.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-12
• Study First Submitted: 2016-12-11
• Study First Submitted QC: 2016-12-13
• Last Update Submitted: 2016-12-13
• Study First Posted: 2016-12-14
• Last Update Posted: 2016-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients who were going to be subjected to ERCP due to different causes

Exclusion Criteria

• Patients with clinically evident acute pancreatitis or hyperamylesemia (≥150 IU/L) before the procedure.
• Current or recent use of allopurinol (within the last 48 hours).
• Hypersensitivity to allopurinol or hydro-soluble contrast solutions.
• Current use of drugs with a known interaction with allopurinol, including cyclophosphamide, chlorpropamide, azathioprine, mercaptopurines, or probenecid.
• NSAIDS intake within a week prior to assessment.
• Previous endoscopic or surgical sphincterotomy.
• Those with severe co-morbid conditions.
• Female patients with a known or suspected pregnancy and/or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Allopurinol	Received 600 mg of allopurinol divided in two oral doses before the procedure (300 mg at 15 hours and 300 mg at 3 hours before ERCP)

Primary Outcome Measures

Name	Time	Method
Diagnosis of procedure-related pancreatitis	At least 24 hours after the ERCP