临床试验/NCT02992652

NCT02992652已完成不适用

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

Ain Shams University0 个研究点目标入组 100 人开始时间: 2011年1月最近更新: 2016年12月14日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Ain Shams University
入组人数: 100
主要终点: Diagnosis of procedure-related pancreatitis

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

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

排除标准

•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.

研究组 & 干预措施

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)

干预措施: Allopurinol (Drug)

结局指标

主要结局

Diagnosis of procedure-related pancreatitis

时间窗: At least 24 hours after the ERCP

次要结局

未报告次要终点

研究者

发起方

Ain Shams University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Sara Abdelhakam

Assistant Professor

Ain Shams University

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