Clinical trial NCT06249841: Feasibility of Cryobiopsy from the Bile Duct - CRYLEO
Official title: Feasibility of in Vivo Percutaneous Cryobiopsy from the Human Bile Duct - CRYLEO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms, Bile Duct
Lead sponsor: Erbe Elektromedizin GmbH
Sponsor class: INDUSTRY
First posted: 2024-02-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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.
timeFrame: 30 days
Secondary outcomes:
measure: Size of biopsy (mean area (in mm2) of each biopsy technique)
timeFrame: 30 days
measure: Percentage of successful retrievals of biopsies by each biopsy technique
timeFrame: 30 days
measure: Representativeness of each biopsy sample
timeFrame: 30 days
measure: Quality of each biopsy sample
timeFrame: 30 days
measure: Grade of crash artifacts occurrence defined as crush artifact area per biopsy
timeFrame: 30 days
measure: Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess
timeFrame: 30 days
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Klinikum Essen
city: Hamburg
country: Germany
facility: Klinikum Hamburg
city: Hanau
country: Germany
facility: Klinikum Hanau
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart
Study officials:
References:
citation: 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.
citation: 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.