Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- survival time
研究概览
简要总结
The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time, decreasing cholestasis and improving health-related quality of life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable cholangiocarcinoma,and to assess the safety of PDT by observing the complications after the procedure.
详细描述
Cholangiocarcinoma (CCA) is difficult to diagnose due to its anatomic location, clinical course, and lack of definitive diagnostic criteria. It is often clinically silent with symptoms developing only in advanced disease. Surgical resection is the recommended curative intervention with only a minority of patients (10-20%) having potentially resectable tumors at time of diagnosis.
Endoscopic palliative therapy in CCA entails the relief of obstructive jaundice through transpapillary or percutaneous insertion of plastic or metal biliary stents. Although biliary decompression provides relief of cholangitis and improvement in quality of life, it does not improve survival.
Photodynamic therapy (PDT) in conjunction with biliary stenting may improve bile duct patency by local obliteration of malignant tissue through the cytotoxic effects of reactive oxygen species. Several studies suggest PDT plus biliary stent placement may prolong survival (range of 360-630 days), reduce cholangitis, and improve the quality of life of patients with advanced disease. The aim of this study is to determine the effectiveness and safety of PDT with biliary stenting compared to biliary stenting alone in the palliative treatment of unresectable CCA in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
PDT+stent
Patients with unresectable CCA are performed PDT and biliary stent with ERCP
干预措施: stent (Device)
stent
Patients with unresectable CCA are performed biliary stent with ERCP alone
干预措施: stent (Device)
PDT+stent
Patients with unresectable CCA are performed PDT and biliary stent with ERCP
干预措施: PDT (Device)
结局指标
主要结局
survival time
时间窗: two years
次要结局
- Karnosky performance status score(two years)
- clinical success rates(two years)
- complications(two years)
研究者
Jianfeng Yang
associate director
First People's Hospital of Hangzhou