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Completed

NCT Number: NCT02992652

Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

* 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.

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Key information

Conditions

Endoscopic Retrograde Cholangiopancreatography

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Diagnosis of procedure-related pancreatitis

    Time frame: At least 24 hours after the ERCP

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 14, 2016
Registry last updated
Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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