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临床试验/CTRI/2025/12/098589
CTRI/2025/12/098589尚未招募不适用

Role of Afferent loop decompression in preventing Clinically Relevant Post Operative Pancreatic Fistula (CR-POPF) after Pancreaticoduodenectomy.

Dipen Dineshbhai Patel1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Incidence of Clinically Relevant Post Operative Pancreatic Fistula

研究概览

简要总结

Study title - Role of Afferent loop decompression in preventing Clinically Relevant Post Operative Pancreatic Fistula (CR-POPF) after Pancreaticoduodenectomy.

Pancreaticoduodenectomy (PD), commonly known as the Whipple procedure, is widely considered the definitive surgical treatment for tumors arising from the periampullary region. POPF remains the most impactful complication following Pancreaticoduodenectomy. CR-POPF occurs in approximately 10% to 30% of cases, with its likelihood influenced by both patient-related and intraoperative variables. Exciting strategies to reduce CR-POPF have limited effectiveness or require expensive adjuncts. Intraluminal pressure is a modifiable factor with strong physiologic link to POPF. Afferent loop decompression is a simple, reproducible and low cost intervention with limited data on effectiveness in preventing CR-POPF. Our study aims to determine incidence of  CR-POPF in patients with Afferent Loop decompression in Pancreaticoduodenectomy compared to standard technique and to determine whether ALD is an effective strategy to decrease burden of CRPOPF.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing Pancreaticoduodenectomy.

排除标准

  • Age less than 18years.
  • Not willing to participate in study.
  • Additional procedure done along with Pancreaticoduodenectomy.

结局指标

主要结局

Incidence of Clinically Relevant Post Operative Pancreatic Fistula

时间窗: At Post Operative Day 3, Day 5, Day 7, and 21

次要结局

  • Incidence of post operative complications : Delayed Gastric Emptying, Post Pancreatectomy Hemorrhagic, Bile Leak, Surgical Site Infection(At Post Operative Day 3, Day 5, Day 7, & 21)

研究者

发起方
Dipen Dineshbhai Patel
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dipen Dineshbhai Patel

Institute of Medical Sciences and SUM Hospital

研究点 (1)

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