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临床试验/NCT04170933
NCT04170933Unknown不适用

A Prospective Study: Magnetic Compression Anastomosis for Recanalization of Biliary Stricture

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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