A Prospective Study: Magnetic Compression Anastomosis for Recanalization of Biliary Stricture
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time duration of biliary recanalization, d (days)
研究概览
简要总结
Biliary stricture is a common complication after end-to-end biliary anastomosis, especially after liver transplantation. This study is designed to investigate the safety and efficacy of magnetic recanalization technique, a newly clinical method, for treating biliary anastomotic stricture.
详细描述
Biliary anastomotic stricture is a common complication of after end-to-end biliary anastomosis. Magnetic recanalization is a promising way to establish connection of biliary tract after stenosis or completed obstruction. This study is designed to investigate the safety and efficacy of magnetic recanalization among patients with severe biliary stricture after biliary anastmosis. Patients who failed to undergo stent placement with endoscopic retrograde cholangiopancretography (ERCP) would be enrolled for magnetic recanalization treatment. Magnetic treatment will be implemented by several steps. Firstly, placement of one magnet through the sinus of percutaneous transhepatic cholangio drainage (PTCD) in upper part of the bile duct; Second, introduction of another magnet via ERCP into the distal part of the bile duct, and making them be mated together; Third, after necrosis of the tissue between the two magnets, the magnets will drop off and be taken out together through the thread connected with them out of the mouth. Last, a plastic stent should be placed in the bile duct for a lasting support. The time of recanalization (drop off of the magnets), and adverse events (e.g. fever, melena, nausea, vomiting, anorexia, hematemesis, abdominal pain, and gastrointestinal bleeding) will be recorded, and each patient will be followed up for long-term outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old and ≤65 years old
- •patients with biliary stricture after end-to-end biliary anastomosis
排除标准
- •Pregnant woman
- •2.Have a history of cardiovascular disease, including coronary heart disease (angina pectoris, myocardial infarction, coronary angiogenesis or electrocardiographic abnormal Q wave (ECG)), stroke (ischemic or hemorrhagic, including transient ischemic attack)
- •Severe lung diseases such as COPD and asthma
- •Patients with acute infection or inflammation (i.e. pneumonia)
- •Any other medical condition considers the longest survival time to be less than 2 years
- •Immunodeficiency or HIV positive
- •No autonomy, inability to participate in follow-up
研究组 & 干预措施
Magnetic recanalization
The subjects in this group will be treated by magnetic recanalization
干预措施: Magnetic recanalization (Procedure)
结局指标
主要结局
Time duration of biliary recanalization, d (days)
时间窗: From date of treatment (two magnets mated together) until the date of drop-off or the two magnets from the biliary tract or date of death from any cause, whichever came first, assessed up to 12 months
Time period for recanalization of the bile duct
次要结局
- Incidence of stricture recurrence(From date of drop-off of the two magnets until the date of biliary stricture recurrence or end of the follow-up or date of death from any cause, whichever came first, assessed up to 12 months)
