SPAnish DIStal PANcreatectomy Snapshot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 主要终点
- Morbidity at 90 days
研究概览
简要总结
Distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. Laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. This technique has low mortality but 30% morbidity mostly related to pancreatic fistula. Some new devices (linear stapler, energy devices and patches) seem to decrease pancreatic fistula but there is not evidence based medicine that confirm the results published usually in unicentric studies.
详细描述
Snapshot observational study including most of the Spanish pancreatic units that perform distal pancreatectomy. One year consecutive cases.
Main objectives.
- percentage of laparoscopic approach in Spain
- Morbidity at 90 days measured by CCI and Clavien Dindo
- Percentage of pancreatic fistula
- Impact of new device to decrease pancreatic fistula
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All distal pancreatectomies performed in involved Units
排除标准
- •No sign of informed consent for entering in the study
- •Emergency procedures
结局指标
主要结局
Morbidity at 90 days
时间窗: 90 days
Morbidity measured with CCI and Clavien at 90 days
Laparoscopic approach
时间窗: 1 year
Laparoscopic or laparotomy approach
次要结局
- Pancreatic fistula(90 days)
研究者
Candido Fernando Alcazar-Lopez
MD PHD Senior consultant HPB surgeon
Hospital General Universitario de Alicante