Biliary Obstruction, Biliary Tract Carcinoma
Conditions
Keywords
cryobiopsy, biliary obstruction, percutaneous transhepatic drainage
Brief summary
The rationale of the study is to explore the safety and efficacy of percutaneously performed endobiliary cryobiopsy in patiens with histologically unverified biliary stenosis.
Detailed description
In patients with malignant biliary stenosis in whom endoscopic retrograde cholangiography (ERCP) is not feasible , percutaneous transhepatic drainage (PTD) is indicated. Biopsy is required for further management of the patient. In patients unsuitable for biopsy under CT or endoscopic guidance, samples can be collected endobiliary by PTD. The biopsy vie PTD can be sampled either at the initial drainage using disposable 5.2F forceps or delayed after 2 or more days using 7.5F endobiliary forceps. An alternative to this procedure is endobiliary sampling by cryobiopsy using 1.1mm, 1.7mm or 2.4mm catheters. To minimize bias, each patient will be sampled both by cryobiopsy and forceps biopsy. The order of cryobiopsy and forceps biopsy will be randomized.
Interventions
DEVICECryobiopsy catheter
Comparison of endobiliary forceps biopsy and cryobiopsy of biliary stenosis during percutaneous transhepatic drainage.
Sponsors
Brno University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
Randomization was performed by the Institute of Biostatistics and Analysis of Masaryk University Brno.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* biliary stenosis of unknown etiology * unsuccessful or unfeasable ERCP * indicated percutaneous transhepatic drainage
Exclusion criteria
* histologically verified biliary stenosis * INR ≥ 1,5
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of biopsy sampling to detect malignancy | up to month 12 or death of the patient | Comparison of sensitivity of endobiliary cryobiopsy and forceps biopsy for detection of malignancy. |
| Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - weight | up to month 12 or death of the patient | Comparison of weight (in milligrams) of samples collected by endobiliary cryopsy and forceps biopsy. Each sample will be weighed separately and one measurement value will be recorded for each sample. |
| Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - size | up to month 12 or death of the patient | Comparison of the size weight (in millimeters) of samples collected by endobiliary cryopsy and forceps biopsy. Each sample will be weighed in two dimensions on slide. |
Countries
Czechia
Contacts
Primary ContactTomáš Andrašina, MD
Backup ContactTomáš Rohan, MD
Outcome results
None listed