Feasibility of Cryobiopsy from the Bile Duct - CRYLEO

Erbe Elektromedizin

Status: Completed

Conditions: Neoplasms, Bile Duct

Treatments: Device: 1.1mm flexible Cryoprobe SU

Study type: Interventional

Funder types: Industry

Identifiers

NCT06249841

CIV-23-06-043299

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Forceps biopsy against Cryoprobe biopsy

Experimental group

Description:

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

Treatment:

Device: 1.1mm flexible Cryoprobe SU

Cryoprobe biopsy against Forceps biopsy

Active Comparator group

Description:

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.

Treatment:

Device: 1.1mm flexible Cryoprobe SU