跳至主要内容
临床试验/NCT07414004
NCT07414004已完成不适用

Comparison of Prognosis Between Open Pancreatic Surgery With Vein Resection and Reconstruction Versus Minimally Invasive Pancreatic Surgery With Vein Resection and Reconstruction for Pancreatic Cancer: A Multicenter Retrospective Cohort Study

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 2,451 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
2,451
试验地点
1
主要终点
incidences of postoperative thrombosis

研究概览

简要总结

The prognostic differences between open and minimally invasive radical pancreatic surgery combined with venous resection and reconstruction remain controversial, and there is a lack of high-quality evidence-based medical evidence to support either approach. Therefore, this study intends to conduct a retrospective cohort analysis, planning to enroll pancreatic cancer patients who have undergone radical pancreatic surgery (open vs. minimally invasive) combined with venous resection and reconstruction from multiple hospitals both domestically and internationally, and to collect relevant data. The primary objective is to evaluate the differences in postoperative thrombosis and the incidence of severe complications between the two groups. Furthermore, prognostic data will be collected to assess the impact of open versus minimally invasive pancreatic surgery combined with venous resection and reconstruction on both short-term and long-term all-cause mortality in pancreatic cancer patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • diagnosis of malignant pancreatic or periampullary lesions requiring surgical pancreatic resection; preoperative imaging confirming venous involvement; undergoing pancreatic resection with simultaneous venous resection and reconstruction; and availability of complete postoperative outcome data, including thrombosis and complication grading.

排除标准

  • preoperative confirmation of distant metastasis.

研究组 & 干预措施

Open

The open pancreatic surgery with venous resection and reconstruction cohort

MIS

The minimally invasive pancreatic surgery with venous resection and reconstruction cohort

结局指标

主要结局

incidences of postoperative thrombosis

时间窗: within 30 postoperative days

incidences of major complication

时间窗: within 30 postoperative days

Postoperative complications were defined and graded according to the Clavien-Dindo (C-D) classification system ranging from Grade I (minor deviation) to Grade V (death), with C-D ≥III being considerated as major complication

次要结局

  • incidence of postoperative pancreatic fistula(within 30 postoperative days)
  • incidence of postoperative delayed gastric emptying(within 30 postoperative days)
  • incidence of postoperative post-pancreatectomy hemorrhage(within 30 postoperative days)
  • postoperative overall survival(before discharge, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively)
  • postoperative recurrence-free survival(before discharge, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验