1. 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. (Time Frame - 30 days): Feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient
Secondary outcome:
1. Size of biopsy (mean area (in mm2) of each biopsy technique) (Time Frame - 30 days): Quality of biopsies
2. Percentage of successful retrievals of biopsies by each biopsy technique (Time Frame - 30 days): Quality of biopsies
3. Representativeness of each biopsy sample (Time Frame - 30 days): 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
4. Quality of each biopsy sample (Time Frame - 30 days): Biopsy quality using a Likert-Scale for each biopsy technique
5. Grade of crash artifacts occurrence defined as crush artifact area per biopsy (Time Frame - 30 days): Quality of biopsies
6. Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess (Time Frame - 30 days): Quality of biopsies
Experimental: 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
Active Comparator: 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.
1.1mm flexible Cryoprobe SU (Comparator: SpyBite Max Forceps): Six tissue samples retrieved by standard biopsy forceps and three samples by cryobiopsy (randomized sequence)
Quelle: ClinicalTrials.gov
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