Feasibility of Cryobiopsy from the Bile Duct - CRYLEO

NCT ID: NCT06249841

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2024-08-30

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

Conditions

Neoplasms, Bile Duct

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

1.1mm flexible Cryoprobe SU

Intervention Type: DEVICE

Six tissue samples retrieved by standard biopsy forceps and three samples by cryobiopsy (randomized sequence)

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.

Group Type: ACTIVE_COMPARATOR

1.1mm flexible Cryoprobe SU

Intervention Type: DEVICE

Six tissue samples retrieved by standard biopsy forceps and three samples by cryobiopsy (randomized sequence)

Interventions

1.1mm flexible Cryoprobe SU

Six tissue samples retrieved by standard biopsy forceps and three samples by cryobiopsy (randomized sequence)

Intervention Type: DEVICE

Other Intervention Names

Comparator: SpyBite Max Forceps

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erbe Elektromedizin GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klinikum Hamburg

Hamburg, City state of Hamburg, Germany

Klinikum Hanau

Hanau, Hanau, Germany

Klinikum Essen

Essen, Hesse, Germany

Klinikum Nürnberg

Nuremberg, Nürnberg, Germany

Klinikum Stuttgart

Stuttgart, Stuttgart, Germany

Countries

Germany

References

Peveling-Oberhag J, Zimmermann C, Linzenbold W, Ott G, Enderle M, Albert JG. Bile duct tissue acquisition by cholangioscopy-guided cryobiopsy technique: first-in-human application. VideoGIE. 2023 Feb 15;8(4):158-161. doi: 10.1016/j.vgie.2022.12.007. eCollection 2023 Apr.

Reference Type: BACKGROUND

PMID: 37095838 (View on PubMed)

Walter D, Peveling-Oberhag J, Schulze F, Bon D, Zeuzem S, Friedrich-Rust M, Albert JG. Intraductal biopsies in indeterminate biliary stricture: Evaluation of histopathological criteria in fluoroscopy- vs. cholangioscopy guided technique. Dig Liver Dis. 2016 Jul;48(7):765-70. doi: 10.1016/j.dld.2016.03.013. Epub 2016 Mar 26.

Reference Type: BACKGROUND

PMID: 27067926 (View on PubMed)

Other Identifiers

CIV-23-06-043299

Identifier Type: -

Identifier Source: org_study_id