jRCT1042260061招募中不适用
A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
未提供0 个研究点目标入组 30 人开始时间: 待定
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with unresectable malignant hilar biliary obstruction
- •Patients with a pathological diagnosis of malignancy
- •Patients requiring biliary drainage due to abnormal values in any of the following: serum total bilirubin, AST, ALT, ALP, or g-GTP
- •The criteria for abnormal values are as follows:
- •Total bilirubin > 2 mg/dL
- •AST > 45 IU/L
- •ALT > 45 IU/L
- •ALP > 450 IU/L
- •g-GTP > 75 IU/L
- •Patients undergoing initial bilateral inside plastic stent placement
- •Patients expected to have a prognosis of at least 2 months
- •Patients with Bismuth type II-IV (requiring bilateral biliary drainage)
- •Age > 18 years
排除标准
- •Patients with concomitant distal biliary obstruction
- •Patients with surgically altered anatomy (excluding Billroth I reconstruction)
- •Patients with severe comorbidities affecting other organs
- •Patients in whom biliary cannulation (transpapillary approach) is not feasible
- •Patients with concomitant duodenal
研究者
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