NCT04170933

Magnetic Compression Anastomosis for Recanalization of Biliary Stricture

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Magnetic recanalization	1. Establish a percutaneous transhepatic cholangio drainage (PTCD) fistula. 2. Perform endoscopic sphincterotomy (EST). 3. Place one magnet above the stricture through the PTCD fistula. 4. Introduce another magnet below the stricture through the common bile duct with ERCP. 5. Place the magnets at the appropriate point to attract each other. 6. The patient will be strictly followed, and the magnets will be taken out out of the mouth by the thread connected with the magnets. 7. A plastic stent will be placed in the bile duct for lasting support.

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-11-20
• Last updated: 2022-05-17

Locations

1 site across 1 country: China