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NCT Number: NCT06249841

Feasibility of Cryobiopsy from the Bile Duct - CRYLEO

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Hamburg, Hamburg, Free and Hanseatic City of Hamburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1.1mm flexible Cryoprobe SU

Device

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

Other names: Comparator: SpyBite Max Forceps

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.

    Time frame: 30 days

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

Secondary outcomes

  1. Size of biopsy (mean area (in mm2) of each biopsy technique)

    Time frame: 30 days

    Quality of biopsies

  2. Percentage of successful retrievals of biopsies by each biopsy technique

    Time frame: 30 days

    Quality of biopsies

  3. Representativeness of each biopsy sample

    Time frame: 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

  4. Quality of each biopsy sample

    Time frame: 30 days

    Biopsy quality using a Likert-Scale for each biopsy technique

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

    Time frame: 30 days

    Quality of biopsies

  6. Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess

    Time frame: 30 days

    Quality of biopsies

Sponsors and collaborators

Lead sponsor

Erbe Elektromedizin GmbH

Industry

Registry information

Official study title

Feasibility of in Vivo Percutaneous Cryobiopsy from the Human Bile Duct - CRYLEO

Acronym: CRYLEO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2024
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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