NCT07832045招募中不适用
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Recurrent biliary obstruction (RBO) rate
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety between EUS-HGAS and EUS-HGS. We hypothesized that EUS-HGAS provides lower recurrent biliary obstruction (RBO) rate but with a comparable safety profile to EUS-HGS.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older with malignant distal biliary obstruction
- •Failed ERCP
- •The papilla is inaccessible owing to a surgically altered anatomy or gastric outlet obstruction
排除标准
- •Patients younger than 18 years old
- •Cancer infiltration of the gastric/duodenal wall within the planned puncture route
- •Patients with uncorrectable coagulopathy
- •Patients with unmanageable ascites
- •Patients with serious comorbidities that prohibited endoscopic management
- •Patients with pregnancy
- •Patients who cannot or refuse to provide informed consent
研究组 & 干预措施
HGS
Active Comparator
Endoscopic ultrasound guided hepaticogastrostomy
干预措施: HGS (Device)
HGAS
Experimental
Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting through the major papilla
干预措施: HGAS (Device)
结局指标
主要结局
Recurrent biliary obstruction (RBO) rate
时间窗: From enrollment to the end of follow-up up to 12 months
the proportion of participants experiencing RBO, defined by cholangitis, jaundice or findings of images, from index day of EUS-BD to the date of last follow-up
次要结局
- Time to Recurrent Biliary Obstruction(From date of enrollment until the date of first documented recurrent biliary obstruction, date of death from any cause or date of last follow-up, whichever came first, assessed up to 12 months)
- Tract dilation success(From the start of the EUS-BD to completion or failure of dilation, assessed on the day of the drainage procedure)
- Final procedure success(From the start of the EUS-BD to completion or failure of stent deployment, assessed on the day of the drainage procedure)
- Procedural duration(The time elapsed between puncture of the intrahepatic duct and completion of deployment of stent, assessed on the day of the drainage procedure.)
- Clinical success(a decrease in bilirubin within 14 days to < 50 % of levels before EUS-BD)
- Adverse events(From the day of procedure to the completion of follow-up up to 12 months)
- Length of hospital stay after procedure(From the day of procedure to discharge, assessed up to 12 months)
- Overall survival(Survival rate at the end of the follow-up period, assessed up to 12 months)
研究者
研究点 (1)
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