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临床试验/NCT05520606
NCT05520606已完成不适用

Minimally Invasive Versus Open for Pancreatoduodenectomy:an Retrospective, Observational, Multicenter Real-world Study

Tongji Hospital0 个研究点目标入组 800 人开始时间: 2014年1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
800
主要终点
Postoperative length of stay

研究概览

简要总结

This is a single, retrospective, real-world study to investigate the surgical outcomes of minimally invasive pancreatoduodenectomy and open pancreatoduodenectomy, with the perioperative characteristics and long-term overall survival being compared. The investigators aimed to find out whether the minimally invasive surgery is safe and feasible for resectable lesions located in the pancreatic head and periampullary region. And the investigators also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.

详细描述

Pancreatoduodenectomy (Whipple surgery) is a complex surgical procedure and has been accepted as the gold standard treatment for resectable lesions of the pancreatic head and periampullary region.To date, how surgeons can safely pass the learning curve of laparoscopic pancreatoduodenectomy (LPD) without potentially harming patients remains a question. Around this topic, the investigators designed real-world study in a single center to retrospectively collect the PD surgeries since July 2014. The investigators aimed to find out whether the minimally invasive surgery is safe and feasible for resectable lesions located in the pancreatic head and periampullary region. And the investigators also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach. Besides, the investigators also want to investigate the clinical characteristics of patients and perioperative outcomes of LPD procedures and aimed to develop and validate a difficulty scoring system for patient selection which could help facilitate a comprehensive and security understanding of LPD for surgeon during different stage of the learning curve.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 to 80 years.
  • Patients underwent PD surgeries.

排除标准

  • Peritoneal seeding or metastasis to distant sites;
  • Incomplete clinical data.

结局指标

主要结局

Postoperative length of stay

时间窗: up to 90 days

defined as the time from being admitted to hospital to discharge

次要结局

  • Overall survival(through study completion, an average of 5 year)
  • Intraoperative blood loss(intraoperative)
  • Reoperation within 90 days(up to 90 days)
  • Mortality(up to 90 days)
  • Operation time(intraoperative)
  • postoperative complications(up to 90 days)
  • R0 resection(intraoperative)
  • Readmission within 90 days(up to 90 days)

研究者

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

Renyi Qin

Professor in Surgery, Chief Physician, Director of Surgical Supervision Department, Deputy Director of Institute of Hepatobiliary&Pancreatic, Director of Department of Biliary-Pancreatic Surgery

Tongji Hospital

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