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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic recanalization | Experimental | The subjects in this group will be treated by magnetic recanalization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic recanalization | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Lv, MD,phD | Contact | 86-29-85323900 | luyi169@126.com | |
| Xu-Feng Zhang, MD,phD | Contact | 86-29-85323626 | xfzhang125@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Lv, MD,phD | First Affiliated Hospital of Xian JiaotongUniversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xian JiaotongUniversity | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D001651 | Cholestasis, Extrahepatic |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
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A prospective study of magnetic recanalization in treatment of biliary stricture
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