The Added Value of Peroral Cholangioscopy in the Diagnosis of Indeterminate Biliary Strictures

Aims Indeterminate biliary strictures (including both malignant and benign conditions) present a diagnostic challenge in the clinical practice. Endoscopic retrograde cholangiopancreatography (ERCP) with brush cytology and biopsy is a traditional method for assessing biliary strictures, but it is limited by its low sensitivity. Aiming at better diagnostic yields, new technologies have emerged to facilitate earlier diagnosis and subsequent treatment in patients. This study aims to assess the effectiveness of single-operator peroral cholangioscopy system (POCS) with its digital version SpyGlass Direct Visualization System with SpyBite biopsies as a promising modality for accurate diagnosis of biliary strictures.

Methods We performed a two- center retrospective analysis of prospective database from March 2019 to August 2024. Eachpatient underwent peroral cholangioscopy using SpyGlass Direct Visualization System with SpyBite biopsies for the diagnosis of indeterminate biliary strictures.

Results We identified 145 patients who underwent peroral cholangioscopy during the study period (86 males and 59 females). The medium age of the patients was 77,4 years. There was 100% technical success of the procedure. All patients underwent POCS due to indeterminate biliary strictures. Benign desease was diagnosed in 33 (22.8%) of them. Visual impression for malignant desease (et least one of the following- tortuous dilated vessels, friability and easily bleeding, inflitrative stricture, polipoid mass, nodular eleveted lesion, vegetative mass, fish-egg lesion, finger – like villiform lesion and irregulary papillary or granular lesion) was found in 112 (77.2%) of patients.The most reliable correlation with malignancy was found to be the presence of inflitrative strictures – 104 (71.7%) patients. A final diagnosis of cholagiocarinoma was established in 75 (51.7%) of them. In 37 (25.5%) 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 74.5%(with 66.9% sensitivity and 100% specificity).

Conclusions Peroral cholangioscopy using SpyGlass Direct Visualization System with SpyBite biopsies provides better diagnostic yield than ERCP with brush cytology and biopsy in terms of sensitivity and specificity, due to endoscopic direct visualization of the biliary system, allowing targeted biopsies. Overall, SpyGlass cholangioscopy with SpyBite biopsies demonstrates moderate sensitivity for the diagnosis of indeterminate biliary strictures. There are still some limitations that need to be addressed in order to improve diagnostic accuracy.

Publication History

Article published online:
27 March 2025