NL-OMON52313招募中不适用
Endobiliary radiofrequency ablation for malignant biliary obstruction due to perihilar cholangiocarcinoma: a randomized controlled trial - RACCOO
Amsterdam UMC0 个研究点目标入组 73 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 73
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 18 years or older.
- •- Capable of providing written and oral informed consent.
- •- Histological or cytological proof of perihilar cholangiocarcinoma
- •(adenocarcinoma).
- •- Perihilar biliary obstruction with indication for drainage with uSEMS.*
- •- Advanced (no candidate for surgical resection) due to metastases, vascular or
- •lymph node (N2). involvement on imaging or during staging laparoscopy according
- •to multidisciplinary team (MDT).
- •*Only patients with pCCA are eligible however in case of reasonable doubt
- •between intrahepatic CCA with a perihilar biliary obstruction or massforming
- •pCCA, patients can be included.
排除标准
- •- Patients who potentially qualify for curative resection of pCCA.
- •- pCCA eligible for liver transplantation.
- •- Life-expectancy less than 3 months.
- •- ERCP and PTC technically not feasible.
- •- Uncontrolled coagulopathy (PTT >1,5x prolonged or thrombocytes below
- •40*10E9/L).
- •- Ongoing cholangitis or liver abscess. Patients are required to be off
- •antibiotic treatment for cholangitis and/or liver abscess at least 7 days.
- •- Any condition that is unstable or that could jeopardize the safety of the
- •subject and their compliance in the study.
- •- Patients who are pregnant or breastfeeding.
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