Cryobiopsy for diagnosing malignant biliary obstruction
Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction
This study is testing a new way to take tissue samples from patients with blocked bile ducts to see if a freezing method works better than the usual method for diagnosing cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brno University Hospital Academic / other |
| Locations | 1 site (Brno) |
| Trial ID | NCT06047990 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of endobiliary cryobiopsy in patients with malignant biliary stenosis who cannot undergo endoscopic retrograde cholangiography (ERCP). It involves percutaneous transhepatic drainage (PTD) to collect biopsy samples, comparing cryobiopsy with traditional forceps biopsy. Patients will be randomized to determine the order of the two biopsy methods to minimize bias in results. The goal is to provide a reliable diagnostic method for patients with unverified biliary obstruction.
Who should consider this trial
Good fit: Ideal candidates are patients with biliary stenosis of unknown etiology who have had unsuccessful or unfeasible ERCP and require percutaneous transhepatic drainage.
Not a fit: Patients with histologically verified biliary stenosis or an INR of 1.5 or higher will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve diagnostic accuracy and treatment options for patients with malignant biliary obstruction.
How similar studies have performed: While the approach of cryobiopsy is relatively novel, similar studies have shown promise in improving biopsy techniques in challenging cases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * biliary stenosis of unknown etiology * unsuccessful or unfeasable ERCP * indicated percutaneous transhepatic drainage Exclusion Criteria: * histologically verified biliary stenosis * INR ≥ 1,5
Where this trial is running
Brno
- Brno University Hospital — Brno, Czechia (Recruiting)
Study contacts
- Study coordinator: Tomáš Andrašina, MD
- Email: andrasina.tomas@fnbrno.cz
- Phone: +420777674769
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.