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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
Six tissue samples retrieved by standard biopsy forceps and three samples by cryobiopsy (randomized sequence)
Klinikum Hamburg
Hamburg, Free and Hanseatic City of Hamburg, Germany
Klinikum Hanau
Hanau, Hanau, Germany
Klinikum Essen
Essen, Hesse, Germany
Klinikum Nürnberg
Nuremberg, Nürnberg, Germany
Klinikum Stuttgart
Stuttgart, Stuttgart, Germany
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.
Feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient
Time frame: 30 days
Size of biopsy (mean area (in mm2) of each biopsy technique)
Quality of biopsies
Time frame: 30 days
Percentage of successful retrievals of biopsies by each biopsy technique
Quality of biopsies
Time frame: 30 days
Representativeness of each biopsy sample
yes: evaluable bile duct epithelia in sufficient quantity and quality to make a diagnosis or no: absent or not sufficiently evaluable bile duct epithelia (e.g. crush artefacts, dissolved tissue association
Time frame: 30 days
Quality of each biopsy sample
Biopsy quality using a Likert-Scale for each biopsy technique
Time frame: 30 days
Grade of crash artifacts occurrence defined as crush artifact area per biopsy
Quality of biopsies
Time frame: 30 days
Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess
Quality of biopsies
Time frame: 30 days
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