Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

NCT02992652 | Completed DMC

• 1 other identifier: 937
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endoscopic Retrograde Cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

• Diagnosis of procedure-related pancreatitis

  At least 24 hours after the ERCP

Study Arms (2)

Study Group

ACTIVE COMPARATOR

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)

Drug: Allopurinol

Control Group

NO INTERVENTION

Underwent ERCP without allopurinol prophylaxis

Interventions

Allopurinol DRUG

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)

Study Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Allopurinol

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 11, 2016
• First Posted: December 14, 2016
• Study Start: January 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 14, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share