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Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction — BICRYOB  

Biliary Obstruction Clinical Trial

Official title:
Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06047990
Study type Interventional
Source Brno University Hospital
Contact Tomáš Andrašina, MD
Phone +420777674769
Email andrasina.tomas@fnbrno.cz
Status Recruiting
Phase N/A
Start date June 1, 2023
Completion date December 31, 2024
View Details
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