Introduction
Indeterminate biliary strictures pose a significant diagnostic challenge, as they can result from a wide spectrum of both benign and malignant conditions. Differentiating between these is crucial due to different management strategies. Conventional methods like endoscopic retrograde cholangiopancreatography (ERCP) with brush cytology have limited sensitivity, often leading to repeated procedures and delays in treatment. Peroral cholangioscopy (POC) offers direct bile duct visualization and targeted biopsies, improving diagnostic accuracy. Modern systems, like the SpyGlass™ DS, enhance procedure feasibility and image quality.
Aims & Methods
Aims: The aim of our study is to assess the effectiveness of single-operator peroral cholangioscopy system (POCS) with its digital version SpyGlassTM Direct Visualization System with SpyBite biopsies as a promising modality for accurate diagnosis of biliary strictures.
Method: We performed a two-center retrospective analysis of prospective database from March 2019 to March 2025. Each patient underwent peroral cholangioscopy using SpyGlassTM Direct Visualization System with SpyBite biopsies for the diagnosis of indeterminate biliary strictures.
Results
We identified 162 patients who underwent peroral cholangioscopy during the study period (96 males and 66 females). The medium age of the patients was 63.04 years. There was 100 % technical success of the procedure. All patients underwent POCS due to indeterminate biliary strictures. Before the procedure CT scan was performed and positive for biliary stenosis in 115 (70.9%) of the cases. The biliary stenoses were located as follows: 20 (12.3%) in the distal common bile duct, 29 (17.9%) in the proximal common bile duct, 102 (62.9%) at the hepatic hilum and 11 (6.7%) in the intrahepatic bile ducts.
Benign disease was diagnosed in 39 (24.07 %) of the patients. Visual impression for malignant desease (at least one of the following- tortuous dilated vessels, friability and easily bleeding, infiltrative stricture, polipoid mass, nodular eleveted lesion, vegetative mass, fish-egg lesion, finger - like villiform lesion and irregular papillary or granular lesion) was found in 123 (75.9%) of the patients. The most reliable correlation with malignancy was found to be the presence of infiltrative strictures - 113 (69.7%) patients. A final diagnosis of cholagiocarinoma was established in 84
(51.8%) of them. In 39 (24.07%) patients, no tumor cells were found in the specimen. Visual impression accuracy with SpyGlass was 100% (with 100% sensitivity and 100% specificity). SpyBite biopsies accuracy was 69.05 % (with 68. 3% sensitivity and 100% specificity).
Conclusion
POC has proven valuable in evaluating indeterminate biliary strictures, offering advantages over ERCP by allowing real-time visualization and targeted biopsies. Our study supports POC's superior accuracy, especially in identifying malignant lesions, with visual impression achieving up to 100% sensitivity and specificity. However, POC adoption is limited by operator expertise, the need for standardized interpretation, and availability. While adverse events are rare (<10%), careful patient selection is essential. In conclusion, POC holds substantial promise as a key diagnostic tool for indeterminate biliary strictures, with ongoing improvements enhancing its clinical role.
Disclosure
No conflict of interest