Feasibility of Cryobiopsy From the Bile Duct – CRYLEO

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Description

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

Targeted Conditions

Study Overview

Start Date
January 31, 2024
Completion Date
March 1, 2025
Enrollment
15
Date Posted
February 8, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Klinikum Hanau
Hanau 63450, Germany

Klinikum Stuttgart
Stuttgart 70174, Germany

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Contact Info

Study Contact Name
Dominique Quetting; Natalia Gebert
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06249841