Magnetic Compression Anastomosis for Recanalization of Biliary Stricture

Xi'an Jiaotong University

Status

Unknown

Conditions

Endotoxicosis

Biliary Anastomotic Stricture

Cholestasis, Extrahepatic

Biliary Tract Diseases

Treatments

Procedure: Magnetic recanalization

Study type

Interventional

Funder types

Other

Identifiers

NCT04170933

XJTU1AF-CRF-2015-001-4

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old and ≤65 years old
1. patients with biliary stricture after end-to-end biliary anastomosis

Exclusion criteria

1. 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)
1. Severe lung diseases such as COPD and asthma
1. Patients with acute infection or inflammation (i.e. pneumonia)
1. Any other medical condition considers the longest survival time to be less than 2 years
1. Immunodeficiency or HIV positive
1. No autonomy, inability to participate in follow-up
1. Illiterate