Benchmarking Outcomes in Pancreatoduodenectomy With Portal Vein Resection - WhippleBenchmarks.Org
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,462
- 试验地点
- 2
- 主要终点
- Mortality rate
研究概览
简要总结
The WhippleBenchmark 2 Collaborative study aims at defining benchmark criteria for best achievable outcomes after pancreaticoduodenectomy with portal vein resection.
详细描述
Pancreatoduodenectomy (PD) with portal vein resection (PVR) is performed for the achievement of complete resection (R0) in patients with locally advanced pancreatic head lesions. Despite most commonly performed in high-volume pancreatic surgery centers by experienced surgeons, best achievable outcomes, such as morbidity and mortality, following such complex procedure remain unknown.
The aim is to conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following duodenopancreatectomy (DP) with portal vein resection (PVR).
Data collection and study design are based on to the well established standardized reporting for benchmarking (Sánchez-Velázquez et. al. Ann Surg, February 2019 ).
This multicenter cohort study will include all consecutive pancreaticoduodenectomies with portal vein resections from at least 20 high volume centers performing over 50 pancreatic operations per year or 150 cases within 3 years from at least 3 continents over a period of 10 years (2009-2019). Every center included in the study must have a prospective database from which data can be collected as well as previous publications critically reporting on their outcome.
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
- 否
入选标准
- •Adults ≥ 18 years
- •Resectable malignant or benign diseases (i.e. all indications)
- •Open pancreaticoduodenectomy (all techniques allowed) with concurrent portal vein resection
排除标准
- •Patients < 18 years
- •Pancreatic resections other than pancreaticoduodenectomy and portal vein resection
- •Pancreaticoduodenectomy with arterial reconstruction
- •Laparoscopic or robotic pancreaticoduodenectomy
结局指标
主要结局
Mortality rate
时间窗: 12 months
Death due to any cause postoperatively
Morbidity rate
时间窗: 12 months
Classified according to the Clavien-Dindo Classification of postoperative complications.
Morbidity assessed according to the Comprehensive Complications Index® (CCI®)
时间窗: 12 months
The Comprehensive Complications Index® (CCI®) reports the cumulative postoperative morbidity, a novel metric which measures the overall morbidity on a scale from 0 (no complications) to 100 (death).
次要结局
- Pancreatic fistula rates(12 months)
- Hospital readmission rate(12 months)
- Disease free survival rate(Up to 10 years postoperatively)
研究者
Dimitri Raptis
Senior Clinical Fellow in HPB and Transplant Surgery
Royal Free Hospital NHS Foundation Trust