Modified One-layer Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Rate of clinically relevant postoperative pancreatic fistula (POPF)
研究概览
简要总结
The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy
详细描述
Duct-to-mucosa and invagination pancreaticojejunostomy are two most commonly used anastomotic techniques after pancreaticoduodenectomy, with comparable incidence rate of pancreatic fistula (PF). We modified the conventional two-layer duct-to-mucosa PJ into one-layer PJ. The aim of this study is to examine if the investigator's modified duct-to-mucosa PJ can reduce PF after PD when compared to invagination PJ.
This trial is a single-center, randomized, controlled, patient- and observer- blinded study, whose primary aim is to assess whether a modified duct-to-mucosa PJ (trial group) is superior to an invagination PJ (control group), in terms of clinically relevant PF and other complications. A total of 380 patients, who are to undergo elective PD, will be recruited and randomized intraoperatively into either of the two groups. The primary efficacy endpoint is the incident rate of clinically relevant PF. Secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay. Patients will be followed up for 3 months. Statistical analysis will be based on the intention-to-treat population. The duration of the entire trial is estimated to be two years.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed consent obtained；
- •Both sexes between 18 and 80 years old；
- •Patients scheduled to elective open pancreaticoduodenectomy.
排除标准
- •Patients with ASA score >=4;
- •Patients who had a previous pancreatic operation;
- •Patients with an immunodeficiency;
- •Patients who underwent an emergency operation;
- •Pregnant patients；
- •Patients who was found that pancreaticoduodenectomy was not suitable。
研究组 & 干预措施
One-layer duct-to-mucosa Group
Modified one-layer duct-to-mucosa pancreaticojejunostomy is used after pancreaticoduodenectomy.
干预措施: Modified one-layer duct-to-mucosa Pancreaticojejunostomy (Procedure)
Invagination Group
Invagination pancreaticojejunostomy is used after pancreaticoduodenectomy.
干预措施: Invagination pancreaticojejunostomy (Procedure)
结局指标
主要结局
Rate of clinically relevant postoperative pancreatic fistula (POPF)
时间窗: Up to 60 days after Surgery
As defined by International Study Group on Pancreatic Fistula, a clinically relevant postoperative pancreatic fistula is now redefined as a drain output of any measurable volume of fluid with an amylase level \>3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula.
次要结局
- Duration of postoperative hospital stay(Up to 90 days after Surgery)
- post-pancreatectomy hemorrhage (PPH)(Up to 60 days after Surgery)
- Overall Morbidity(Up to 60 days after Surgery)
- Anastomosis time(intraoperatively)
- Delayed gastric emptying(Up to 60 day after Surgery)
- Mortality(Up to 90 days after Surgery)
- Reoperation rate(Up to 90 days after Surgery)
- Readmission rate(Up to 60 days after Surgery)
- Chyle leak(Up to 60 days after Surgery)
研究者
Yi Miao, Prof.
Director of Pancreas Center
Nanjing Medical University