Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter

Introduction In patients with a biliary obstruction, tissue is acquired immediately before drainage during endoscopic retrograde cholangio-pancreatography (ERCP). This is performed by passing a brush inside the bile duct stricture. However, brush cytology has a modest sensitivity (30-57%) for the diagnosis of cancer. A device, called the "G.I.U.M." catheter, allows for the sampling of higher amounts of tissue during ERCP compared to brush cytology. The aim of this study is to compare the diagnostic yield of tissue sampling performed in patients with a suspected malignant biliary stricture using 2 techniques, namely a standard brush catheter and the G.I.U.M.. Protocol design Eligible patients will have tissue sampling performed using both techniques during ERCP, the first technique used being randomly assigned and immediately followed by the other one as well as biliary decompression. All specimens obtained will be subjected to cytopathological examination. After inclusion of the total number of patients, smears will be anonymized and analyzed for diagnosis, cell cellularity and quality. The final clinical diagnosis in each case will be based on cytologic results plus histological examination of biopsy specimens.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Suspicion of malignant biliary stricture without prior histopathologic confirmation;
* Informed consent for ERCP, including sampling and dilation modalities, obtained.

Exclusion Criteria:

* Coagulopathy not corrected by administration of vitamin K or fresh frozen plasma;
* Inability to pass a guidewire through the stricture;
* Hilar stricture