An Unicentric RCT About Novel Radiation Stent Versus Nitinol SEMS for Palliative Treatment of Malignant Biliary Stricture
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Overall Mean Survival and Median Survival
研究概览
简要总结
Malignant biliary obstruction is a common clinical condition caused by various malignancies. Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the most important methods for relieving malignant biliary obstruction. However, the benefit for the survival of the patients with palliation of the stent treatment is limited because no therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by the success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded with 125I radioactive seeds has been developed in our institute. After ex vivo and in vivo evaluations for the delivery system, the investigators prospectively compare the responses to treatment with this radiation biliary stent, versus the conventional biliary SEMS in patient with malignant biliary obstruction.
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
- Single (Participant)
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
- •Age 18 years old or older
- •Biliary obstruction by any malignant process with histologically or cytologically confirmed by biopsy or previous surgical procedures
- •Clinical symptoms of biliary obstruction
- •Unresectable or refused to be surgically treated biliary obstruction by any malignant process
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study
排除标准
- •Suspected benign bile duct stricture
- •Strictures that can not be dilated enough to pass the delivery system
- •Perforation of any duct within the biliary tree
- •Presence metallic biliary stent or bile duct surgery
- •Patients for whom PTC procedures are contraindicated
- •Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
- •Noncooperation or no authorization and signature
结局指标
主要结局
Overall Mean Survival and Median Survival
时间窗: follow-up in interval of stent insertion and death (3 years)
次要结局
- Number of Participants with Adverse Events as a Measure of Technical Success, Clinical Success, Safety (including WBC and Immunological changes of lab, Leakage of the radioactive seeds and Complications related to the procedure.(follow-up in interval of stent insertion and death (3 years))
研究者
Gao-Jun Teng
Director of Department of Radiology
Southeast University, China