Primary Cholangioscopy Versus ERCP in the Diagnosis of Biliary Strictures
Biliary Stricture
About this trial
This is an interventional diagnostic trial for Biliary Stricture focused on measuring suspected malignant biliary stricture, primary peroral cholangiscopy, endoscopic retrograde cholangiopancreatography, fluorescence in situ hybridization
Eligibility Criteria
Inclusion Criteria:
- Suspected malignant biliary stricture
- Localization: Extrahepatic biliary duct
- Patient´s consent with a diagnostic procedure
- Age : 18 years or more
Exclusion Criteria:
- Intrahepatic biliary strictures
- Duodenal stenosis (endoscopically)
- Age : < 18 years
Coagulopathy :
(INR >1,5, Platelets < 100)
- Pregnancy
Sites / Locations
- 2nd Department of Internal Medicine, University Hospital and Palacký University, Olomouc, Czech RepublicRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
peroral Cholangioscopy examination
ERCP examination with sampling
Patient with suspected malignant biliary stricture (SMBS) is allowed: to the peroral Cholangioscopy examination with both visual and tissue diagnosis. The visual diagnosis is based on morphological and vascular patterns (presence or not of nodular or papilary masses, irregularity of the surface, morphology of the vessels and the fragility of mucosa). The tissue diagnosis consists on cytopathological evaluation after tissue sampling using minuature biopsy forceps (SpyBite). During this, 5-8 samples are taken under visual control, from different parts of the lesion.
Patient with suspected malignant biliary stricture (SMBS) is allowed: to ERCP examination with both sampling by brushing and forceps biopsy, with subsequent pathological evaluation and an additional fluorescence in situ hybridization(FISH) examination of the specimens. ERCP (Endoscopic retrograde cholangiopancreatography) is the most widely used diagnostic procedure in patients with biliary obstruction. It enables to identify the biliary stricture, to determinate its location and help providing tissue sampling from the stricture for cytological evaluation. Brushing and endocanal forceps biopsies were the most used techniques, both with different specificity and sensitivity. It was demonstrated that Fluorescence in Situ Hybridization (FISH) improved the diagnostic yield of routine cytology. That is the reason why the investigators will combine FISH with the sampling methods to maximize the chance to make early diagnosis of the biliary stenosis.