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NCT02992652 Clinical Trial

Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Official title:
Role of Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02992652
Other study ID # 937
Secondary ID
Status Completed
Phase N/A
First received December 11, 2016
Last updated December 13, 2016
Start date January 2011
Est. completion date December 2014

Study information
Verified date December 2016
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

  • Endoscopic Retrograde Cholangiopancreatography
  • Pancreatitis

Intervention

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)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnosis of procedure-related pancreatitis At least 24 hours after the ERCP Yes
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