Endobiliary Radiofrequency Ablation With S-1 in Patients With Unresectable Cholangiocarcinoma: A Prospective Randomized Trial With Open Label Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- survival time
研究概览
简要总结
Endobiliary radiofrequency ablation (RFA) with biliary stent has been reported to be a beneficial treatment option for palliation of malignant biliary strictures. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased tumor ingrowth. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to evaluate the combined effect of RFA and S-1 in patients with unresectable cholangiocarcinoma.
详细描述
Over 60 % of common bile duct (CBD) obstructions are due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis. Biliary drainage with placement of metal or plastic stents for palliation is the therapy of choice in this set of patients.
Radiofrequency ablation (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. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Many studies showed RFA with biliary stent was a beneficial treatment option for palliation of malignant biliary strictures. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma.
The aim of this study is to conduct a randomised, controlled, clinical trial to compare the effect of S-1 plus RFA with stent with RFA with stent in patients with unresectable cholangiocarcinoma.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obtention of a written informed consent.
- •Patient over
- •Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA.
- •Patient with Karnofsky score ≥ 50 %
- •Patient capable of fill in the quality of life questionnaire.
排除标准
- •No written informed consent.
- •Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
- •Patients with porphyria or hypersensibility to porphyrins.
- •Pregnant, parturient or breastfeeding women.
- •Patient under 18.
研究组 & 干预措施
RFA+stent+S-1
Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Patients will receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement, and be treated with S-1 began within 1 month after RFA.
干预措施: radiofrequency ablation (Device)
RFA+stent+S-1
Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Patients will receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement, and be treated with S-1 began within 1 month after RFA.
干预措施: S-1 (Drug)
RFA+stent+S-1
Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Patients will receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement, and be treated with S-1 began within 1 month after RFA.
干预措施: Stent (Device)
RFA+stent
Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Patients will only receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement
干预措施: radiofrequency ablation (Device)
RFA+stent
Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Patients will only receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement
干预措施: Stent (Device)
结局指标
主要结局
survival time
时间窗: two years
Compare overall survival time in patients with unresectable cholangiocarcinoma treated with RFA combined with or without S-1
次要结局
- frequency of repeat RFA(two years)
- the frequency of cholangitis(two years)
- adverse events(two years)
研究者
Jianfeng Yang
Deputy irector
First People's Hospital of Hangzhou