Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The time taken to insert bilateral stent
研究概览
简要总结
Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.
Bilateral drainage is more physiologic and have more long patency than unilateral drainage.
There are two methods of bilateral drainage: Y-stent and side by side.
However there are no clinical data about comparing the effectiveness of these two methods.
Therefore the investigators want to compare the clinical outcomes of two methods:
Y-stent and side by side.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy
排除标准
- •patients with endoscopic retrograde cholangiogram is not possible
- •bleeding tendency (PT INR > 1.5, platelet < 50,000)
- •poor general condition (ECOG 3-4) or cardiopulmonary deterioration
- •pregnancy
研究组 & 干预措施
Y-stent
Y-stent insertion group
干预措施: Y-stent (BONASTENT M-Hilar) (Device)
parallel stent
parallel stent insertion group
干预措施: parallel stent (Procedure)
结局指标
主要结局
The time taken to insert bilateral stent
时间窗: After the ERCP procedure
次要结局
未报告次要终点
研究者
Kwang Hyuck Lee
Assistant Professor of Medicine
Samsung Medical Center