Neoplasms, Bile Duct
Conditions
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
Interventions
DEVICE1.1mm flexible Cryoprobe SU
Six tissue samples retrieved by standard biopsy forceps and three samples by cryobiopsy (randomized sequence)
Sponsors
Erbe Elektromedizin GmbH
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 30 days | Feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of successful retrievals of biopsies by each biopsy technique | 30 days | Quality of biopsies |
| Representativeness of each biopsy sample | 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 |
| Size of biopsy (mean area (in mm2) of each biopsy technique) | 30 days | Quality of biopsies |
| Grade of crash artifacts occurrence defined as crush artifact area per biopsy | 30 days | Quality of biopsies |
| Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess | 30 days | Quality of biopsies |
| Quality of each biopsy sample | 30 days | Biopsy quality using a Likert-Scale for each biopsy technique |
Countries
Germany
Outcome results
None listed