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临床试验/NCT07147374
NCT07147374已完成不适用

Robotic Versus Open Surgery Following Neoadjuvant Therapy in Pancreatic Cancer: Evaluation of Safety and Oncologic Outcomes

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Overall complication

研究概览

简要总结

The feasibility and safety of minimally invasive surgery in cases after neoadjuvant therapy were unclear. It is worth exploring the safety of robotic resection for pancreatic cancer following neoadjuvant therapy. The investigators investigated the comparative outcomes of robotic and open surgery in the management of pancreatic cancer after NAT, exploring the feasibility and safety of robotic procedures in complex cases of pancreatic cancer, and providing evidence-based guidance for clinical practice.

详细描述

Currently, most studies focus on upfront resectable pancreatic cancer, benign or low-grade malignant tumors, demonstrating that robotic surgery can shorten postoperative hospital stays, reduce intraoperative blood loss, and achieve oncological outcomes comparable to open surgery. The feasibility and safety of minimally invasive surgery in cases after NAT were unclear. Both the Miami international evidence-based consensus and the Brescia international validated European guidelines indicate that current data are insufficient to recommend minimally invasive approaches for pancreatic cancer resection following NAT, highlighting the need for additional research. Therefore, it is worth exploring the safety of robotic resection for pancreatic cancer following NAT.

The investigators investigated the comparative outcomes of robotic and open surgery in the management of pancreatic cancer after NAT, exploring the feasibility and safety of robotic procedures in complex cases of pancreatic cancer, and providing evidence-based guidance for clinical practice.

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

  • Age over 18 years.
  • Received neoadjuvant chemotherapy.
  • Postoperative pathology confirmed pancreatic cancer.
  • Underwent either open or robotic surgery.

排除标准

  • Intraoperative discovery of unresectable tumor or presence of distant metastasis.
  • ASA score ≥ 4.

结局指标

主要结局

Overall complication

时间窗: Until the 90 days after surgery

The complication occurred within 90 days after the surgery

次要结局

  • Clinically relevant postoperative pancreatic fistula(Until the 90 days after surgery)
  • Postoperative pancreatectomy hemorrhage(Until the 90 days after surgery)
  • Disease-free survival(Up to 2 years after the surgery)
  • Overall survival(Up to 2 years after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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