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临床试验/NCT07388082
NCT07388082已完成不适用

Total Laparoscopic vs Open Pancreaticoduodenectomy for the Treatment of Periampullary Adenocarcinomas

Theodor Bilharz Research Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
The incidence of pancreatic fistula after laparoscopic pancreaticoduodenectomy in comparison to open surgery

研究概览

简要总结

Laparoscopic pancreaticoduodenectomy (LPD), a surgical option for nonpancreatic periampullary adenocarcinoma (NPPA), is a complex procedure that has become increasing popular. However, there is no consensus as to whether this technique should be performed routinely. Our aim was to evaluate the outcomes of LPD compared with open pancreaticoduodenectomy (OPD).

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

  • • Body mass index <28.0 kg/m
  • Ampullary tumors, duodenal tumors restricted to the second part of the duodenum, or lower common bile duct tumors.
  • Carefully confirmed resectability of the tumors based on preoperative radiology conducted by experienced radiologists and surgeons.

排除标准

  • • Patients with >180 degrees superior mesenteric artery encasement
  • Any celiac abutment.
  • Unreconstructable superior mesenteric vein/portal occlusion" Aortic invasion or encasement.
  • A history of previous upper abdominal surgery.
  • Tumors extending to the uncinate.
  • Severe cardiorespiratory comorbidities.

研究组 & 干预措施

conventional open pancreaticoduedectomy

Active Comparator

15 patients underwent conventional open pancreaticoduedenctomy

干预措施: Conventional open pancreaticoduedectomy (Procedure)

Total laparoscopic pancreaticoduedectomy

Active Comparator

15 patients underwent total laparoscopic pancreaticoduedectomy

干预措施: Total laparoscopic pancreaticoduedectomy (Procedure)

结局指标

主要结局

The incidence of pancreatic fistula after laparoscopic pancreaticoduodenectomy in comparison to open surgery

时间窗: in 2 years between 2023 - 2025

Laparoscopic pancreaticoduodenectomy is a complex procedure that has become increasing popular. However, there is no consensus as to whether this technique should be performed routinely. Our aim was to evaluate the outcomes of Laparoscopic pancreaticoduodenectomy compared with open pancreaticoduodenectomy.

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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