Feasibility of in Vivo Percutaneous Cryobiopsy from the Human Bile Duct - CRYLEO
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 10
- 主要终点
- The primary endpoint of this study is feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient.
研究概览
简要总结
This is a multi-center, prospective, feasibility study using a 1.1 mm flexible cryoprobe SU via percutaneous access in the bile duct. The device has a CE-approval. First feasibility and safety for application assessed in the bile duct performed ex vivo and in a patient case report study. The study will take place at 5 different sites in Germany. Recruitment is competitive. In total, 15 patients will be enrolled. Patients are screened for study inclusion at the participating hospitals.
Primary objective:
• Feasibility of percutaneous cryobiopsy in the bile duct
Secondary objectives:
- Size of biopsy (mean area (in mm2) of each biopsy technique)
- Percentage of successful retrievals of biopsies by each biopsy technique
- Representativeness of each biopsy sample
- Quality of each biopsy sample
- Grade of crash artifacts occurrence defined as crush artifact area per biopsy
- Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Suspicion of any neoplastic alterations in the bile duct system or other indication for biopsy sampling in the bile duct
- •A percutaneous drainage or an access by means of percutaneous transhepatic cholangiodrainage (PTCD) has been previously established independent from study participation, without adverse events
- •Patient is at least 18 years of age
- •According to physicians' assessment, patient is able to follow study protocol or is able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation, able to comply with study requirements and understand and independently sign the Informed Consent Form
排除标准
- •• Presence of hereditary bleeding disorder, e.g. hemophilia A or hemophilia B
- •Severe impairment of partial thromboplastin time (PTT) of >80s; International normalized ratio (INR) >3; platelet count <50,000 /nl
- •Dual antiplatelet therapy (change to aspirin monotherapy is no exclusion criterion)
- •Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is no exclusion criterion) Patient is participating in another clinical study pregnant or breast-feeding or intending to get pregnant during the study
研究组 & 干预措施
Forceps biopsy against Cryoprobe biopsy
A total of 6 forceps biopsies and 3 cryobiopsies will be taken for each patient, corresponding to a 2:1 ratio. The biopsies are divided into blocks of two (6 forceps, 3 cryo). The biopsy technique blocks are randomized, resulting in a sequence of 6 forceps biopsies followed by 3 cryobiopsies
干预措施: 1.1mm flexible Cryoprobe SU (Device)
Cryoprobe biopsy against Forceps biopsy
A total of 6 forceps biopsies and 3 cryobiopsies will be taken for each patient, corresponding to a 2:1 ratio. The biopsies are divided into blocks of two (6 forceps, 3 cryo). The biopsy technique blocks are randomized, resulting in a sequence of 3 cryobiopsies followed by 6 forceps biopsies.
干预措施: 1.1mm flexible Cryoprobe SU (Device)
结局指标
主要结局
The primary endpoint of this study is feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient.
时间窗: 30 days
Feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient
次要结局
- Quality of each biopsy sample(30 days)
- Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess(30 days)
- Percentage of successful retrievals of biopsies by each biopsy technique(30 days)
- Size of biopsy (mean area (in mm2) of each biopsy technique)(30 days)
- Representativeness of each biopsy sample(30 days)
- Grade of crash artifacts occurrence defined as crush artifact area per biopsy(30 days)