Evaluation of Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 960
- 试验地点
- 1
- 主要终点
- Postoperative Pancreatic Fistula(POPF)
研究概览
简要总结
To date, pancreaticoduodenectomy (PD) is the only recognized potentially curative therapy for malignant neoplasms located in the peri-ampullary region, and is increasingly being used for the treatment of cancer through the resection of the premalignant precursors for invasive carcinomas.Postoperative pancreatic fistula (POPF) is one of the most common complications associated with substantial clinical implications following PD, which significantly affects mortality rate, length of hospital stay, and overall hospital costs. Therefore, the prevention of POPF has always been a high priority for our group as well as other international surgical groups. In 1995, investigators' group established the Chen's U-stitch approach, which was a new technique of end-to-end invaginated pancreaticojejunostomy with transpancreatic transverse U-sutures after PD, and the preliminary results were quite encouraging at that time. Thus, investigators intend to conduct a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the effect and safety of the new technique.
详细描述
This is a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the effect and safety of Chen's U-Suture technique for pancreaticojejunostomy following pancreaticoduodenectomy. Investigators plan to enroll 960 patients in this study and eligible patients will be randomly divided into two groups. One group will use Chen's U-Suture technique and other group will use classic duct-to-mucosa technique. All patients will be followed up for 3 month after surgery, and primary outcome is POPF, other outcome such as duration of operation, grade of POPF, morbidity, mortality, length of hospital stay, reoperation rate, postoperative pancreatic function and postoperative incidence of chronic pancreatic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 75 years of age, inclusive.
- •Patients have a diagnosis of benign and malignant diseases of the pancreatic head and periampullary region and requiring pancreaticoduodenectomy.
- •Patients have not been treated with any anticancer medications and immunotherapy prior to surgery
- •Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc., and can generally tolerable for surgery.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Female subjects who are pregnant or breastfeeding.
- •Patients scheduled to undergo pancreatogastrostomy.
- •Patients whose pancreatic duct cannot be located.
- •Patients with history of previous pancreatic surgery, server acute or chronic disease or surgical contraindication.
- •Patients with HIV-infectious or other AIDS-related disease.
- •Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
结局指标
主要结局
Postoperative Pancreatic Fistula(POPF)
时间窗: Within 30 days after surgery
POPF will be strictly classified according to IGSPF criteria
次要结局
- Mortality(Within 30 days after surgery)
- Reoperation rate(Within one year after surgery)
- Grade of POPF(Within 30 days after surgery)
- Morbidity(Within 90 days after surgery)
- Duration of operation(Intraoperative)
- Length of hospital stay after surgery(From first day after surgery to release from hospital (anticipate 5 days minimally))
- Postoperative pancreatic function(Within one year after surgery)
- Postoperative incidence of chronic pancreatic diseases(Within one year after surgery)
研究者
Chen Xiaoping
Principal Investigator
Tongji Hospital