Feasibility of Cryobiopsy from the Bile Duct - CRYLEO

Not Applicable

Completed

• Conditions: Neoplasms, Bile Duct
• Interventions: Device: 1.1mm flexible Cryoprobe SU

• Registration Number: NCT06249841
• Lead Sponsor: Erbe Elektromedizin GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Study Start: 2024-03-04
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Forceps biopsy against Cryoprobe biopsy	1.1mm flexible Cryoprobe SU	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
Cryoprobe biopsy against Forceps biopsy	1.1mm flexible Cryoprobe SU	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.

Primary Outcome Measures

Name	Time	Method
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.	30 days	Feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient

Secondary Outcome Measures

Name	Time	Method
Percentage of successful retrievals of biopsies by each biopsy technique	30 days	Quality of biopsies
Quality of each biopsy sample	30 days	Biopsy quality using a Likert-Scale for each biopsy technique
Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess	30 days	Quality of biopsies
Size of biopsy (mean area (in mm2) of each biopsy technique)	30 days	Quality of biopsies
Representativeness of each biopsy sample	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
Grade of crash artifacts occurrence defined as crush artifact area per biopsy	30 days	Quality of biopsies

Trial Locations

Locations (5)

Klinikum Essen; 🇩🇪 Essen, Germany

Klinikum Hanau; 🇩🇪 Hanau, Germany

Klinikum Nürnberg; 🇩🇪 Nürnberg, Germany

Klinikum Stuttgart; 🇩🇪 Stuttgart, Germany

Klinikum Hamburg; 🇩🇪 Hamburg, Germany