Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure: a Prospective Case-control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of anastomotic fistula
研究概览
简要总结
Magnetic anastomosis has been attempted in biliary and intestinal reconstruction. Based on our initial experience, the investigators have successfully utilized magnetic anastomosis for biliojejunostomy and pancreaticojejunostomy during pancreaticoduodenectomy. The current study was to design a prospective and case-control study with utilization of magnetic compression anastomosis for pancreaticojejunostomy and biliojejunostomy in Whipple's procedure versus traditional hand-sewn technique on the postoperative morbidity, such as biliary/pancreatic fistula, hemorrhage, anastomotic stenosis, etc. In addition, the investigators are seeking to assess the safety and formation of the anastomosis by magnetic technique.
详细描述
The magnets used in the current study consists of a mother and daughter magnets. An 8-Fr nasogastric tube is tightly fixed with the mother magnet, which will be used for bile or pancreatic drainage before formation of anastomoses. The outside diameter (OD) of the magnets ranges from 5mm to 15mm. In fact, for biliojejunostomy, larger magnets are applied, whereas for pancreaticojejunostomy, smaller magnets are routinely used. This study is a single-center, parallel controlled trial to evaluate the safety and effectiveness of magnetic compression technique for biliojejunostomy and pancreaticojejunostomy, versus traditional hand-sewn techniques on the postoperative morbidity of the patients. And also how to avoid mutual attraction of the two pairs of magnets, formation of bilio-/pancreaticojejunostomy time, discharge rule of the magnets will be all evaluated in the current study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with age between 18 to 75
- •Patients' gender was not limited
- •Patients who were well-diagnosed and had the indication for anastomosis.
- •Patients whose lifetimes will be longer than 12 months.
- •Patients who are willing to join this clinical trial and informed consent form voluntarily.
排除标准
- •Woman during pregnancy or lactation or anyone with mental disorder
- •The wall of biliary duct or jejunum was too thick so that the attractive force of magnetic device cannot meet the requirements of compression.
- •Any anatomical variation in bile ducts system or the inner diameter is too small so that the magnetic device cannot place in.
- •Any foreign body has been implanted in body, such as heart pacemaker.
- •Surgical contraindication, including:
- •Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long-term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.
- •Any other disease in perioperation periods which needs MRI examination in the next 8 weeks post operation.
结局指标
主要结局
Incidence of anastomotic fistula
时间窗: 1 month post operation
Incidence of biliary or pancreatic fistula after surgery
次要结局
- Length of bilio-/pancreaticojejunostomy time(during operation)
- Hospitalization cost(1 to 4 weeks postoperation)
- Incidence of pancreaticojejunostomic stricture(12 months post operation)
- average length of postoperative hospital stay(1 to 4 weeks postoperation)
- incidence of biliojejunostomic stricture(12 months post operation)