Feasibility of Cryobiopsy from the Bile Duct - CRYLEO

NCT06249841 | Completed

• 1 other identifier: CIV-23-06-043299
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (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.

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

  30 days

Secondary Outcomes (6)

• Size of biopsy (mean area (in mm2) of each biopsy technique)

  30 days

• Percentage of successful retrievals of biopsies by each biopsy technique

  30 days

• Representativeness of each biopsy sample

  30 days

• Quality of each biopsy sample

  30 days

• Grade of crash artifacts occurrence defined as crush artifact area per biopsy

  30 days

Study Arms (2)

Forceps biopsy against Cryoprobe biopsy

EXPERIMENTAL

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

Device: 1.1mm flexible Cryoprobe SU

Cryoprobe biopsy against Forceps biopsy

ACTIVE COMPARATOR

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.

Device: 1.1mm flexible Cryoprobe SU

Interventions

1.1mm flexible Cryoprobe SU DEVICE

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

Also known as: Comparator: SpyBite Max Forceps

Cryoprobe biopsy against Forceps biopsy; Forceps biopsy against Cryoprobe biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erbe Elektromedizin GmbH: lead

Study Sites (5)

Klinikum Hamburg

Hamburg, Hamburg, 20246, Germany

Location

Klinikum Hanau

Hanau, Hanau, 63450, Germany

Location

Klinikum Essen

Essen, Hesse, 45147, Germany

Location

Klinikum Nürnberg

Nuremberg, Nürnberg, 90419, Germany

Location

Klinikum Stuttgart

Stuttgart, Stuttgart, 70174, Germany

Location

Related Publications (2)

• 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.

  PMID: 37095838 BACKGROUND

• 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.

  PMID: 27067926 BACKGROUND

MeSH Terms

Conditions

Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 8, 2024
• Study Start: March 4, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

DE (5)