A Modified Omental Patch Work Decreases Pancreatic Fistula After Laparoscopic Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- pancreatic fistula
研究概览
简要总结
Pancreaticoduodenecotmy(PD) is considered as the standard procedure for peri-amplullary or pancreatic head tumors. Laparoscopic pancreaticoduodenctomy(LPD) has been reported with minimal invasive advantages, such as small incision, less blood loss, less pain, et al. Further, some trials showed LPD got less morbidity and shorter length of stay. Pancreatic fistula is the major complication for pancreaticodupdenectomy and associated with numerous serious complications, suffering reoperation or sometimes death. The reported rate was 10% to 55%. A lot of modified procedure have been proposed to reduce pancreatic fistula. Omental flaps around anastomosis have been used to prevent post pancreaticoduodenectomy fistula or hemorrhage. However, the outcomes are controversy. A modified omental patch work has been used during LPD and the initial outcomes are good. This is a pilot study to evaluate the function of the modified omental patch work on decreasing the pancreatic fistula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Disease of periampullary or pancreatic head tumor
- •. Age: 18 years or older
- •Distant metastases are not diagnosed preoperatively.
- •. Patients who can provide written informed consent
排除标准
- •. Patients with severe organ disease such as cardiac disease,respiratory illness
- •. Patients with extended LPD or vessels reconstruction
- •Patients with conversion to laparotomy
- •. Patients with pregnancy
结局指标
主要结局
pancreatic fistula
时间窗: 90 days
Incidence of pancreatic fistula grade B/C defined by ISGPF classification
次要结局
- Mortality(90 days)
- morbidity(90 days)
- Postoperative hospital stay(90 days)
研究者
Yi-Ping Mou
Professor
Zhejiang Provincial People's Hospital