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