Evaluation of Bile Duct Patency After Photodynamic Therapy in Unresectable Cholangiocarcinoma：a Prospective Non-randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 11
- 主要终点
- Bile duct patency
研究概览
简要总结
Comparison of the bile duct patency with photodynamic therapy (PDT) and regular Endoscopic Retrograde Cholangiopancreatography(ERCP) stents in unresectable cholangiocarcinoma.
详细描述
Cholangiocarcinoma is a malignant tumor originating from the bile duct epithelium, accounting for about 70% of the malignant tumors of the bile duct system. Patients have no obvious clinical symptoms in the early stage. After late diagnosis, the effective treatment is surgical resection and & or liver transplantation, and chemotherapy is only used as adjuvant or palliative treatment. Some types of cholangiocarcinomas, such as hilar cholangiocarcinomas, are difficult to achieve radical resection due to their anatomical location, early invasions and are prone to recurrence with a poor long-term efficacy after surgery. Therefore, the comprehensive treatment of cholangiocarcinoma by multiple means urgently needs to be explored. In recent years, photodynamic therapy (PDT), as a new local treatment method, has attracted increasing attention.
This study investigates the bile duct patency and effectiveness of photodynamic therapy compare with ordinary ERCP treatment for cholangiocarcinoma including the median survival, overall survival, and other indicators of side effects.
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
- Double (Investigator, 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
- •ERCP cholangiocarcinoma（the tumor is unresectable or patient can't accept surgery in the situation, the tumor can be resected but the patients cannot tolerate surgery）;
排除标准
- •Proximal cholangiocarcinoma (Bismuth type Ⅲ-Ⅳ, or intra-hepatic cholangiocarcinoma);
- •Patients with Karnofsky Performance Scale (KPS) score≤70；
- •Expected survival≤3months；
- •Patients with porphyria；
- •Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count(<50×10^9 / L) or using anti-coagulation drugs；
- •Bilirubin could not be reduced to less than 100mmol/L within 1 month after drainage；
- •Patients have intrahepatic metastasis or distant metastasis；
- •Patients with no pathological diagnosis；
- •known to allergic to study drug(porphyrin drugs) or other similar and related compounds；
- •Other photosensitizers have been used within 4 weeks prior；
- •Metal biliary stents were placed previously；
- •Patients with contraindications to ERCP；
- •Patients with HIV infection；
- •Pregnant, parturient, or breastfeeding women；
- •Patients complicated with other malignant tumors；
- •Patients with severe liver function damage；
- •Patients who were in cachexia, liver abscess, or advanced patients who were unable to tolerate PDT；
- •Patients with other serious physical or mental illnesses that prevent researchers to enroll them in this study as subjects；
- •Patients with other contraindications for photodynamic therapy.
研究组 & 干预措施
PDT with stent
Before photodynamic therapy, candidate patients undergoing biliary biopsy and biliary duct drainage. If pathology shows a bile duct malignancy, PDT therapy will carry out until total bilirubin drops below 100 μmol/L.Patients with negative skin test of hematoporphyrin Injection (3.0-5.0mg/Kg plus saline 250 mL intravenous drip, the drip was completed within 1 hour) and keep patients away from the light. The first PDT therapy was performed 24 hours after infusion of hematoporphyrin injection by ERCP. The biliary tumor necrosis was observed and the biliary tract was cleaned up 24 hours later and then PDT therapy showed again if necessary. Multiple plastic stents or metal stent will be placed. Follow up regularly after the procedure, PDT therapy would be given again in 3 months.
干预措施: Hematoporphyrin (Drug)
结局指标
主要结局
Bile duct patency
时间窗: 3years (every 3 months or obstruction appears)
Patency period of the stents after treatment
Median survival time
时间窗: 3years (every 3 months）
The time of the half of the patients survived after initial therapy
次要结局
- Overall survival(5years (every 3 months）)
- Karnofsky Performance Scale(1year (baseline and every 3 months）)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30(1year (baseline and every 3 months）)
- The change of weight in kilograms(1year (baseline and every 3 months）)
- Cumulative treatment costs(5years (baseline and in each year）)
- Beck Anxiety Inventory(1year (baseline and every 3 months）)
研究者
Xun Li
Director，M.D., Ph.D.
Hepatopancreatobiliary Surgery Institute of Gansu Province