Neoplasms, Bile Duct Clinical Trial
Official title:
Feasibility of in Vivo Percutaneous Cryobiopsy From the Human Bile Duct - CRYLEO
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
n/a