Biopsy of Indeterminate Biliary Strictures - Does Direct Visualization Help? - A Multicener Experience

Abstract

Background & Aim: Endoscopic retrograde cholangiography (ERC)-guided brushings and biopsies of indeterminate biliary strictures have low sensitivity for detection of malignancy. Targeted biopsies under direct visualization by peroral cholangioscopy may improve diagnostic sensitivity of intraductal biopsies. Methods: As part of an international multicenter registry, 60 patients with indeterminate biliary strictures or filling defects underwent ERC followed by peroral cholangioscopy using SpyGlass Direct Visualization System (Boston Scientific, Natick, USA). This system includes a reusable optical probe and a disposable catheter with 4-way tip deflection, dedicated irrigation channels, and 1.2 mm working channel accommodating the disposable SpyBite biopsy forceps. Procedural success was defined as ability to visualize target lesion and obtain adequate biopsies for histology. Per protocol, patients with benign biopsies undergo 12 months of follow-up or until definitive diagnosis of malignancy is established, whereas those with biopsies consistent with malignancy undergo 1 month of follow-up. Approximately 50% of patients have 6 months of follow-up. Enrollment and follow-up are ongoing. Results: Indications for cholangioscopy with biopsy were indeterminate strictures in non-PSC patients (62%), dominant PSC strictures (14%), non-diagnostic prior tissue sampling (10%), indeterminate filling defects (7%), non-diagnostic prior ERC findings (2%), and other (5%). Biopsies were obtained in CBD (36%), Hilum (26%), CHD (24%), LHD (10%), and RHD (5%). Procedural success was achieved in 53/60 (88%) of patients. Ability to obtain biopsy was reported as good or excellent in 76%, fair in 20% and poor in 3% of cases. Mean number of biopsy attempts per patient was 4.4 and mean number of biopsies obtained per patient was 3.7. Amount of tissue obtained was deemed adequate in 87% of the cases. Sensitivity, specificity, PPV and NPV of biopsies for detection of malignancy in 29 patients who had at least 6 months of follow-up were 78%, 100%, 100% and 60% respectively. There were 5 deaths, none related to devices or ERC or cholangioscopy procedures. There were 8 serious device and/or procedure related adverse event, 6 resolved without sequelae and 2 are resolving: 2 cholangitis (3.3%), 2 bacteremia (3.3%), 1 liver abscess with sepsis and cholangitis (1.7%), 1 nausea (1.7%), 1 transient hypotension (1.7%), and 1 radiculopathy (1.7%). Conclusions: Targeted biopsies using SpyGlass DVS is feasible, safe and well tolerated. Biliary biopsies obtained under direct visualization by peroral cholangioscopy have high sensitivity for diagnosis of pancreatobiliary malignancies.