Morbidity and Survival After Minimally Invasive Versus Open Pancreatoduodenectomy: Propensity Score Matched Comparison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Major complication rate
研究概览
简要总结
Minimally invasive pancreatoduodenectomy is increasingly performed. However, technical challenges and a perceived higher risk of complications has hindered wide adoption of a minimally invasive approach.
This is a retrospective comparison of a prospectively kept database. The investigators compared surgical outcomes and survival after laparoscopic (LPD) versus open pancreatoduodenectomy (OPD). In order to reduce the effect of bias and confounding, baseline characteristics of both groups were matched using propensity score matching.
详细描述
All pancreatoduodenectomies were retrieved from a prospectively kept database and retrospectively analysed. All procedures were performed in a single supra-regional Belgian centre.
The primary endpoint was the major complication rate, defined by a Clavien-Dindo morbidity classification grade IIIa or higher [11]. Secondary endpoints were 90-day mortality rate, length of hospital stay, operative time, blood loss, transfusion requirements and specific pancreatic complications (pancreatic fistula, haemorrhage, and delayed gastric emptying). In addition, overall survival (OS) and disease-free survival (DFS) were analysed in the subgroups of cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •diagnosis of lesion of pancreatic head or peri-ampullary organs
排除标准
- •< 18 years old
结局指标
主要结局
Major complication rate
时间窗: 90 days postoperative
Complications classified as morbidity classification 3a or greater (Clavien-Dindo)
次要结局
- Postoperative morbidity(90 days)
- Perioperative outcomes(Up to 30 days)
- Pancreatectomy-specific complications(90 days)
- Short-term postoperative outcomes(Up to 30 days)
- Overall survival and disease-free survival(Up to 20 years)
- Oncological outcomes(Up to 20 years)
研究者
Dr. M. D'hondt
Dr. Mathieu D'Hondt, Principal investigator
General Hospital Groeninge