Clinical trial NCT04170933: Magnetic Compression Anastomosis for Recanalization of Biliary Stricture
Official title: A Prospective Study: Magnetic Compression Anastomosis for Recanalization of Biliary Stricture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biliary Anastomotic Stricture
Biliary Tract Diseases
Cholestasis, Extrahepatic
Endotoxicosis
Keywords: Magnetic recanalization
Biliary Anastomotic Stricture
Biliary Tract Diseases
Cholestasis, Extrahepatic
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective study of magnetic recanalization in treatment of biliary stricture
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 1. Age ≥ 18 years old and ≤65 years old
* 2. 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)
* 3. Severe lung diseases such as COPD and asthma
* 4. Patients with acute infection or inflammation (i.e. pneumonia)
* 5. Any other medical condition considers the longest survival time to be less than 2 years
* 7. Immunodeficiency or HIV positive
* 8. No autonomy, inability to participate in follow-up
* 9. Illiterate

Primary outcomes:
measure: Time duration of biliary recanalization, d (days)
timeFrame: 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
Secondary outcomes:
measure: Incidence of stricture recurrence
timeFrame: 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
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian JiaotongUniversity
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian JiaotongUniversity
name: Yi Lv, MD,phD
role: PRINCIPAL_INVESTIGATOR
References: