Magnetic Compression Anastomosis for Recanalization of Biliary Stricture

Biliary Tract Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04170933
• Other study ID #: XJTU1AF-CRF-2015-001-4
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yi Lv, MD,phD
• Phone: 86-29-85323900
• Email: luyi169[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Anastomotic Stricture
• Biliary Tract Diseases
• Cholestasis
• Cholestasis, Extrahepatic
• Constriction, Pathologic
• Endotoxicosis

Intervention

Procedure:
• Magnetic recanalization
Establish a percutaneous transhepatic cholangio drainage (PTCD) fistula. Perform endoscopic sphincterotomy (EST). Place one magnet above the stricture through the PTCD fistula. Introduce another magnet below the stricture through the common bile duct with ERCP. Place the magnets at the appropriate point to attract each other. The patient will be strictly followed, and the magnets will be taken out out of the mouth by the thread connected with the magnets. A plastic stent will be placed in the bile duct for lasting support.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian JiaotongUniversity	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time duration of biliary recanalization, d (days)	Time period for recanalization of the bile duct	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	Incidence of stricture recurrence	Incidence of biliary stricture recurrence after magnetic recanalization treatment	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