An interventional study of Magnetic recanalization in Biliary Anastomotic Stricture, Biliary Tract Diseases and Cholestasis, Extrahepatic, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
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.
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.
55 studies on the registry are indexed under Biliary Tract Diseases; 13 are open to participants now.
This study's planned enrollment of 60 is below the median of 88 across 33 interventional studies indexed under Biliary Tract Diseases.
Browse Biliary Tract Diseases studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
The subjects in this group will be treated by magnetic recanalization
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.
Time duration of biliary recanalization, d (days)
Time period for recanalization of the bile duct
Time frame: 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
Incidence of stricture recurrence
Incidence of biliary stricture recurrence after magnetic recanalization treatment
Time frame: 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
Plan to share: Undecided
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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University →