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Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

NCT ID: NCT02992652

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-12-31

Brief Summary

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* 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

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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.

Conditions

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Endoscopic Retrograde Cholangiopancreatography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type 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)

Control Group

Underwent ERCP without allopurinol prophylaxis

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abdelhakam

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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937

Identifier Type: -

Identifier Source: org_study_id