NCT05546372招募中不适用
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2022年10月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Time to biliary obstruction
研究概览
简要总结
A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •18 years or older.
- •Capable of providing written and oral informed consent.
- •Histological or cytological proof of perihilar CCA (adenocarcinoma).
- •Perihilar biliary obstruction with an 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.
研究组 & 干预措施
Endobiliary RFA + stent placement
Experimental
干预措施: Endobiliary radiofrequency ablation (eRFA) (Device)
Endobiliary RFA + stent placement
Experimental
干预措施: uncovered self-expanding metal stent (uSEMS) (Device)
Stent placement only
Active Comparator
干预措施: uncovered self-expanding metal stent (uSEMS) (Device)
结局指标
主要结局
Time to biliary obstruction
时间窗: Through study completion, max 1 year
Defined as period between initial procedure and recurrence of biliary obstruction. Recurrence of biliary obstruction is defined as recurrent jaundice (conjugated bilirubin ≥ 40 umol/l (≥2.3 mg/dl)), presence of biochemical evidence of cholestasis along with dilatation of the drained bile duct(s), or endoscopic findings suggesting stent occlusion.
次要结局
- Stent patency after repeated eRFA.(Through study completion, an average of 1 year)
- Quality of life expressed in quality adjusted life-years (QALYs)(Through study completion, max 1 year)
- Number of patients with technical success of initial ablation(During intervention)
- Need for external drainage catheters.(Through study completion, an average of 1 year)
- Adverse events within 30 days after the procedu(30 days)
- Presumed reason of recurrent biliary obstruction(Through study completion, an average of 1 year)
- Overall survival.(Through study completion)
- Healthcare costs.(Through study completion, max 1 year)
- Number of patients with functional success(14 days)
- Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage.(Through study completion, an average of 1 year)
- Time to re-intervention.(Through study completion, an average of 1 year)
研究者
Rogier P. Voermans
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (2)
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