Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Cholangiocarcinoma
- 发起方
- Bing Hu
- 入组人数
- 174
- 试验地点
- 6
- 主要终点
- Overall survival
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage is accepted approaches for the relief of jaundice in malignant biliary obstruction. But restoration of bile flow have few improvement of the survival of cancer patient. By using endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour growth, which might improve the survival of patients. The feasibility and safety of this technique using HabibTM EndoHBP probe has been evident. The aims of this randomised, controlled, multicentre study is to evaluate whether endobiliary radiofrequency ablation(RFA) can improve the median survival of patients with unresectable biliary malignancy.
详细描述
RFA is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. It uses bipolar electrical energy for tissue coagulation and can be easily applied during endoscopic retrograde cholangiopancreatography (ERCP). Endobiliary radiofrequency can destruct the tumor tissue and has potential benefit for controlling tumour growth. Several cohort studies have been published and the feasibility and safety of such technique has been proved. The aims of this study is to conduct a randomised, controlled, multicentre clinical trial to compare the effect of endobiliary RFA plus biliary stenting with only biliary stenting in patients with unresectable cholangiocarcinoma or ampullary carcinoma. The objectives are * To evaluate whether endobiliary RFA prior to biliary stenting can improve the patients' survival as compared to the only stenting therapy. * To assess the impact of RFA on the stent's patency.
研究者
Bing Hu
Professor, Head of Endoscopy Center
Eastern Hepatobiliary Surgery Hospital
入排标准
入选标准
- •Either gender greater than or equal to 18 years of age.
- •Cholangiocarcinoma or ampullary cancer unsuitable for surgical resection by staging, comorbidities or patient wishes. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced.
- •Biliary obstruction, Bilirubin \> 40umol/L at diagnosis
- •Subjects capable of giving informed consent
- •Life expectancy of at least 3 months
- •Histologically (preferred) or radiologically confirmed cholangiocarcinoma or ampullary cancer
排除标准
- •Cardiac Pacemaker
- •Patient unstable for endoscopy
- •Inability to give informed consent
- •Coagulopathy (INR \> 2.0 or PTT \> 100 sec or platelet count \< 50,000)
- •Performance status ECOG ≥3 (confined to bed / chair \> 50% waking hours)
- •Active suppurative cholangitis
- •Complex stenoses will not be eligible for the trial
- •Patients without access to duodenum or ampulla are not candidates for ERCP and stenting
- •Malignant ascites
- •Presence of main portal vein thrombosis
结局指标
主要结局
Overall survival
时间窗: 2 years
次要结局
- Serious adverse events(30 days)
- Unscheduled readmission rates(6 months)
- Patency of stents(6 months)