A Prospective Open-Label Clinical Study to Evaluate the Efficacy and Safety of Magnetic Compression Anastomosis in Patients with Biliary Stricture or Bile Duct Disconnection Following Cholecystectomy or Living Donor Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of patients with success of MCA
研究概览
简要总结
This is a prospective, single-arm, open-label clinical study evaluating the efficacy and safety of Magnetic Compression Anastomosis (MCA) in patients with biliary strictures or bile duct disconnection following cholecystectomy or living donor liver transplantation. Eligible patients will undergo MCA on Day 1 after screening and consent. Follow-up visits will occur at Day 7, Day 30, Day 90, Day 180, Day 270, and Day 360, with additional visits for magnet or catheter removal as needed. The primary endpoint is successful biliary recanalization without surgical revision. Secondary endpoints include time to magnet removal, catheter duration, hospital stay, and complication rates over 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with age between 18 to
- •Impassable bile duct stenosis or disconnection due to Bile duct injury sustained during cholecystectomy or Living Donor Liver Transplantation.
- •Willing to give informed consent.
排除标准
- •Woman during pregnancy or lactation or anyone with mental disorder.
- •The wall of biliary duct or jejunum was too thick (more than 3mm) so that the attractive force of magnetic device cannot meet the requirements of compression.
- •Anatomical variation in bile ducts system or the inner diameter is too small precluding placement of magnet.
- •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 peri operation periods (before, during, or immediately after surgery) which needs MRI examination in the next 8 weeks post operation.
结局指标
主要结局
Proportion of patients with success of MCA
时间窗: Day 1,Day 7, Day 30 ,Day 90,Day 180, Day 270 and Day 360
次要结局
- Time from MCA procedure to magnet removal(Duration of internal catheter)
研究者
Dr Sanjay Rajput
Ansh Clinic