跳至主要内容
临床试验/NCT07333755
NCT07333755已完成4 期

New Technique of End-to-Side Two-Layered Duct-to-Mucosa Pancreaticojejunostomy With Omental Wrapping and Glue (Glubran 2) During Laparoscopic Whipple Operation

Theodor Bilharz Research Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月5日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
The rate of pancreatic fistula after pancreaticoduodenectomy

研究概览

简要总结

Following pancreaticoduodenectomy, omental flaps around the pancreatic anastomosis and adhesive glue can lower the risk of pancreatic fistula, post-pancreatectomy bleeding, and delayed gastric emptying. The overall morbidity following pancreaticoduodenectomy can be decreased with this straightforward and efficient treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • - Resectable tumors of the periampullary region

排除标准

  • Pancreatic or duodenal tumors
  • Irresectability criteria (such as metastases, ascites, or arterial vascular invasion)

研究组 & 干预措施

A double-layered, end-to-side pancreaticojejunostomy without omental patch or glue

Active Comparator

干预措施: Pancreaticojejunostomy without omental patch (Procedure)

A double-layered, end-to-side pancreaticojejunostomy with omental patch and Glue

Active Comparator

干预措施: Pancreaticojejunostomy with omental patch and glue (Procedure)

结局指标

主要结局

The rate of pancreatic fistula after pancreaticoduodenectomy

时间窗: 4 weeks postoperative

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Rady

Lecturer of general surgery

Theodor Bilharz Research Institute

研究点 (1)

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