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临床试验/NCT04779788
NCT04779788Unknown不适用

I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma

Xuzhou Central Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Overall survival

研究概览

简要总结

Malignant biliary obstruction usually arise in patients suffering from primary or metastatic hepatobiliary tumors. Approximately 80% of malignant biliary obstruction patients are not eligible for surgical resection, and as such palliative stent insertion is the only treatment option available for most patients. At present, I-125 seeds loaded stent has been developed to improve the stent patency and patients' survival. Hilar malignant biliary obstruction is an important part of malignant biliary obstruction. Hilar cholangiocarcinoma is the most common disease which causes hilar malignant biliary obstruction. Herein, we assessed the clinical and long-term efficacy of I-125 seeds loaded stent insertion for hilar cholangiocarcinoma patients.

详细描述

Malignant biliary obstruction usually arise in patients suffering from primary or metastatic hepatobiliary tumors. Approximately 80% of malignant biliary obstruction patients are not eligible for surgical resection, and as such palliative interventions are the only treatment option available for most patients. Of the available palliative treatments, percutaneous or endoscopic stent insertion is the most frequently used to treat malignant biliary obstruction patients.

Although stent insertion can achieve the good short-term outcomes for patients with malignant biliary obstruction, stent dysfunction remains a common outcome in these treated patients, limiting the long-term efficacy of this treatment strategy. In order to overcome this shortcoming of the normal stent insertion, many researchers have developed a novel biliary I-125 seeds loaded stent. The I-125 seeds loaded stents not only can effectively relieve the jaundice, but also can provide the brachytherapy to the tumor. Previous meta-analyses also indicated that showed that relative to normal stent insertion, I-125 seeds loaded stent insertion was associated with longer survival and stent patency in inoperable malignant biliary obstruction patients. However, most previous studies included malignant biliary obstruction patients with different cancer types and malignant biliary obstruction sites, and therefore, the risk of bias did exist. Therefore, there is a clear need for a study comparing these two stent types in patients with a single type of cancer.

Hilar malignant biliary obstruction is an important part of malignant biliary obstruction. Hilar cholangiocarcinoma is the most common disease which causes hilar malignant biliary obstruction. Herein, we assessed the clinical and long-term efficacy of I-125 seeds loaded stent insertion for hilar cholangiocarcinoma patients.

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

入选标准

  • Patients with a diagnosed hilar Cholangiocarcinoma; Inoperable cases; Patients showed evidence of obstructive jaundice; Eastern Cooperative Oncology Group performance status < 4.

排除标准

  • Patients who underwent post-operative external radiotherapy; Patients in whom prior biliary stent insertion or drainage were performed; Patients suffering from serious dysfunction of the pulmonary, renal, cardiac, or coagulatory systems.

结局指标

主要结局

Overall survival

时间窗: From the date of randomization until the date of first documented death from any cause, assessed up to 12 months

From the date of randomization until the date of first documented death from any cause.

次要结局

未报告次要终点

研究者

发起方
Xuzhou Central Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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