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临床试验/NCT05722548
NCT05722548尚未招募2 期

Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis-A Randomized Controlled Trial

Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 200 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
200
主要终点
Post-pancreatectomy Acute Pancreatitis

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

详细描述

The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • *All patients planned to undergo pancreatectomy.

排除标准

  • allergic reactions to NSAIDs
  • internal hemorrhoids
  • anti-platelet medications

研究组 & 干预措施

Group A

Experimental

Patients will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment

干预措施: Indomethacin suppository (Drug)

Group A

Experimental

Patients will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment

干预措施: Standard Medical Treatment (Other)

Group B

Active Comparator

Standard Medical Treatment

干预措施: Standard Medical Treatment (Other)

结局指标

主要结局

Post-pancreatectomy Acute Pancreatitis

时间窗: 2 weeks after pancreatectomy

次要结局

  • Peripancreatic abscess(30 days after pancreatectomy)
  • Length of hospital stay(30 days after pancreatectomy)
  • Pancreatic Fistula(30 days after pancreatectomy)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yingbin Liu, MD, PhD, FACS

prof.

Shanghai Jiao Tong University School of Medicine

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