Clinical trial · Interventional
Feasibility of Cryobiopsy from the Bile Duct - CRYLEO
Feasibility of in Vivo Percutaneous Cryobiopsy from the Human Bile Duct - CRYLEO
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Bile Duct | Bile Duct Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1.1mm flexible Cryoprobe SU | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Forceps biopsy against Cryoprobe biopsy
- 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
- interventionNames
- Device: 1.1mm flexible Cryoprobe SU
- type
- ACTIVE_COMPARATOR
- label
- Cryoprobe biopsy against Forceps biopsy
- 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.
- interventionNames
- Device: 1.1mm flexible Cryoprobe SU
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDPeveling-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
- BACKGROUNDWalter 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