Superior Bilioenteric Anastomosis by Magnetic Compressive Technique: A Multicenter, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Bilioenteric anastomotic leakage
研究概览
简要总结
The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on superior bilioenteric anastomosis.
详细描述
The superior bilioenteric anastomosis is one of the most common and difficult operations in Hepatobiliary Surgery. The traditional manual anastomosis has become one of the main prognosis factors because of the length of suture time, the difficulty of operation, the high incidence of anastomotic leakage and stricture. Magnetic compressive anastomosis can realize the fast anastomosis, reduce the difficulty, and reduce the incidence of anastomotic leakage and stricture. Currently, the majority of studies of magnetic compressive bilioenteric anastomosis are merely confined within clinical case report and single-center, small sample, retrospective study, thus they are lack of convictive evidence of evidence-based medicine for the security, reliability and convince.
This study is a multicenter, prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive superior bilioenteric anastomosis, this study compared the incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need superior bilioenteric anastomosis operation. The study design plan to enroll 70 patients and divide into Study Group (Group A: Magnetic compressive anastomosis) and Control Group (Group B: traditional manual anastomosis) as 1:1 ratio randomly by stratification factors. The incidence of anastomotic leakage and stricture, length of bilioenteric anastomosis time, value of serum bilirubin, length of discharge time of magnetic device and mean time of hospital stay will be evaluated. The patients will drop out of the study if adverse events happen, active request for dropping out, new-onset severe disease or death. The primary and secondary end point will be observed by regular follow-up.
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
- Single (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
- •Patients with age between 18 to 75
- •Patients' gender was not limited
- •Patients who were well-diagnosed and had the indication for superior bilioenteric 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 hepatic 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.
研究组 & 干预措施
Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis.
干预措施: Magnetic Compressive Anastomosis (Device)
Traditional Manual Anastomosis
A handsewn technique will be used during bilioenteric anastomosis.
干预措施: Manual Anastomosis (Procedure)
结局指标
主要结局
Bilioenteric anastomotic leakage
时间窗: 1 month post operation
次要结局
- Length of bilioenteric anastomosis time(during operation)
- Number of patients who have discharged the device on the date expected.(1 to 4 weeks postoperation)
- Number of patients who have been diagnosed as discharge disorder of magnetic device(less than 1 week or more than 4 weeks)
- average length of postoperative hospital stay(3 months)
- Times of pathological examination of bile duct's remnant of Klatskin' tumor(during operation)
- Bilioenteric anastomotic stricture(Time Frame: 1,3,6,12-month post operation)