Comparison of chemotherapy combined with percutaneous electroporation and chemotherapy alone in the management of locally advanced carcinoma of the gall bladder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Gall bladder carcinoma (GBC) is the most common malignancyof the biliary tract worldwide. However, most of the patients often presentlate. Therefore, surgical resection may not be possible due to adjacent organinvolvement or local invasion. Chemotherapy is the first line of treatment inunresectable GB masses with dismissal prognosis. In electrochemotherapy (ECT),the short-term electric pulses with high voltage delivered to the tumor, leadsto transient pore formation in the cell membrane which enables the entry ofchemotherapeutic agents into the cells. The hypothesis of this study is thatthe chemotherapy with electroporation may improve the outcome of GBC. This is arandomized control trial of 30 patients with locally advanced GBC who will bedesignated randomly into two equal groups. Group I will receive only chemotherapywhile Group II will receive both chemotherapy and percutaneous electroporation.The primary outcome will be overall survival and the secondary outcome will besafety and quality of life after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with unresectable malignant GB masses
- •Life expectancy of at least 3 months.
- •Size of tumor < 6 cm in largest dimension.
- •Total bilirubin level < 2.5 mg/dl.
排除标准
- •Uncorrectable coagulopathy
- •Patients with poor general condition and estimated life expectancy less than 3 months
- •Patients unfit for general anaesthesia
- •Presence of cardiac disease/arrhythmia/heart block
- •Presence of malignant ascites
- •Presence of metastatic disease.
结局指标
主要结局
Survival
时间窗: One year
次要结局
- Safety of the procedure(Quality of life)
