Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - weight
研究概览
简要总结
The rationale of the study is to explore the safety and efficacy of percutaneously performed endobiliary cryobiopsy in patiens with histologically unverified biliary stenosis.
详细描述
In patients with malignant biliary stenosis in whom endoscopic retrograde cholangiography (ERCP) is not feasible , percutaneous transhepatic drainage (PTD) is indicated. Biopsy is required for further management of the patient. In patients unsuitable for biopsy under CT or endoscopic guidance, samples can be collected endobiliary by PTD. The biopsy vie PTD can be sampled either at the initial drainage using disposable 5.2F forceps or delayed after 2 or more days using 7.5F endobiliary forceps. An alternative to this procedure is endobiliary sampling by cryobiopsy using 1.1mm, 1.7mm or 2.4mm catheters. To minimize bias, each patient will be sampled both by cryobiopsy and forceps biopsy. The order of cryobiopsy and forceps biopsy will be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
盲法说明
Randomization was performed by the Institute of Biostatistics and Analysis of Masaryk University Brno.
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
- •biliary stenosis of unknown etiology
- •unsuccessful or unfeasable ERCP
- •indicated percutaneous transhepatic drainage
排除标准
- •histologically verified biliary stenosis
- •INR ≥ 1,5
结局指标
主要结局
Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - weight
时间窗: up to month 12 or death of the patient
Comparison of weight (in milligrams) of samples collected by endobiliary cryopsy and forceps biopsy. Each sample will be weighed separately and one measurement value will be recorded for each sample.
Sensitivity of biopsy sampling to detect malignancy
时间窗: up to month 12 or death of the patient
Comparison of sensitivity of endobiliary cryobiopsy and forceps biopsy for detection of malignancy.
Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - size
时间窗: up to month 12 or death of the patient
Comparison of the size weight (in millimeters) of samples collected by endobiliary cryopsy and forceps biopsy. Each sample will be weighed in two dimensions on slide.
次要结局
未报告次要终点
研究者
Tomas Andrasina
Tomáš Andrašina, MD, PhD; Assistant professor, Head of Non-vascular interventions and Computed Tomography of the Department of Radiology and Nuclear Medicine
Brno University Hospital