Randomized Controlled Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Comparison of patency of the bile duct between normal and Kaffes stenting.
研究概览
简要总结
Biliary anastomotic strictures (post liver transplantation) occur in 15-20 % of the cases. Biliary stenting using plastic prosthesis during a period of 1 year is the treatment of choice. Problematic in this approach is the regular change, necessary to overcome occlusion of the stent, resulting in cholestasis and/or infection. This change needs to be performed every 3 months or more frequently in patients with symptoms of stent occlusion.
The Kaffes stent (RMS) is a metallic removable stent, especially constructed for the treatment of biliary anastomotic strictures post liver transplantation. The advantage could be that this stent is less prone to occlusion with a lower change frequency (e.g. every 6 months).
No randomized, controlled trial (RCT) or data exist comparing plastic stenting versus Kaffes stenting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after orthotopic liver transplantation with a choledocho- choledochal anastomosis, presenting with an anastomotic stricture
- •diagnosis established by :
- •elevated liver tests
- •a narrowing of the anastomosis on Magnetic resonance cholangiopancreatography (MRCP): with or without intrahepatic bile duct dilatation
- •no acute or chronic rejection
- •no Cytomegalovirus (CMV) infection
- •no other possible causes of elevated liver tests
- •confirmation of the stricture needs to be confirmed during the diagnostic endoscopic retrograde cholangiopancreatography (ERCP) procedure immediately before the therapeutic procedure.
排除标准
- •non-anastomotic strictures
- •absence of informed consent
- •Roux-en-Y construction
- •Living related liver transplantation patients.
研究组 & 干预措施
Plastic stenting
Patients will be randomized towards plastic stenting.
干预措施: Plastic stenting (Procedure)
Kaffes stenting
Patients will be randomized towards Kaffes stenting.
干预措施: Kaffes stenting (Procedure)
结局指标
主要结局
Comparison of patency of the bile duct between normal and Kaffes stenting.
时间窗: after 6 months and after 1 year
Comparison of patency of the bile duct 6 months after 1 year of stenting. Patency is defined as the presence of normal liver function test (direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (gamma-GT), alkaline phosphatase) and non-dilated bile ducts on Magnetic resonance cholangiopancreatography (MRCP). In the presence of cytomegalovirus (CMV) infection, rejection or other causes of possible disturbed liver function parameters, the MRCP findings rule over the lab tests.
次要结局
- Duration of hospitalization(during a period of 1 year)
- safety of the Kaffes stent(during a period of 1 year)
- Number of stent changes(during a period of 1 year)
- Comparison of costs between normal stenting and Kaffes stenting.(during a period of 1 year)