Percutaneous Transluminal Forceps Biopsy Combined With Transhepatic Biliary Drainage in the Management of Patients With Obstructive Jaundice: Efficacy, Safety and Accuracy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Efficacy of PTBD
研究概览
简要总结
To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous transluminal forceps biopsy combined with transhepatic biliary drainage in patients with biliary stricture
详细描述
Biological parameters of liver function, histopathology of specimens, comparison with others clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy, endoscopic biopsy) were recorded Comparison between pathological findings of surgery or endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up of the patient 12 months after biopsy Evaluation of complications, accuracy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with biliary strictures without histology available
排除标准
- •Pregnant patients
结局指标
主要结局
Efficacy of PTBD
时间窗: 7 days
Efficacy of PTBD : bilirubinemia after PTFB at Day 7
incidence of PTFB-related adverse events
时间窗: up to 1 month after procedure
Number of patients with PTFB related adverse-events as assessed by Society of Interventional Radiology Standards of Practice Committee classification
accuracy for percutaneous biliary biopsy (PTFB)
时间窗: from baseline up to 1 month
Accuracy of PTFB : percentage of true positive and true negative results by pathologists
次要结局
未报告次要终点