Clinical trial · Interventional
Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction
NCT06047990CI-TRIAL-00069772BICRYOBunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The rationale of the study is to explore the safety and efficacy of percutaneously performed endobiliary cryobiopsy in patiens with histologically unverified biliary stenosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Obstruction | — | UNRESOLVED | — |
| Biliary Tract Carcinoma | Biliary Tract Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryobiopsy catheter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cryobiopsy
- description
- In randomised patients in experimental arm was initially performed cryobiopsy (3 samples) and cosequently forceps biopsy (6 samples) with 5.2F or 7.5F forceps. Both sampling techniques were performed during one procedure of percutaneous transhepatic drainage under fluoroscopic control.
- interventionNames
- Device: Cryobiopsy catheter
- type
- ACTIVE_COMPARATOR
- label
- Forceps biopsy
- description
- In randomised patients in control arm was initially performed forceps biopsy (6 samples) with 5.2F or 7.5F forceps and cosequently cryobiopsy (3 samples). Both sampling techniques were performed during one procedure of percutaneous transhepatic drainage under fluoroscopic control.
- interventionNames
- Device: Cryobiopsy catheter
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * biliary stenosis of unknown etiology * unsuccessful or unfeasable ERCP * indicated percutaneous transhepatic drainage Exclusion Criteria: * histologically verified biliary stenosis * INR ≥ 1,5
References
Publications (0)
Data not yet available
No reference posted for this study.