Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT02992652

Collaborator

(none)

100

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Retrograde Cholangiopancreatography	Drug: Allopurinol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Role of Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Study Group 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 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)
No Intervention: Control Group Underwent ERCP without allopurinol prophylaxis

Arm

Intervention/Treatment

Active Comparator: Study Group

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

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)

No Intervention: Control Group

Underwent ERCP without allopurinol prophylaxis

Outcome Measures

Primary Outcome Measures

Diagnosis of procedure-related pancreatitis [At least 24 hours after the ERCP]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sara Abdelhakam, Assistant Professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT02992652

Other Study ID Numbers:

First Posted:

Dec 14, 2016

Last Update Posted:

Dec 14, 2016

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Pancreatitis

Allopurinol

Study Results

No Results Posted as of Dec 14, 2016