Accuracy of digital single-operator cholangioscopy for the diagnostic strategy for indeterminate biliary stricture

Aims Indeterminate biliary strictures diagnosis is challenging despite the availability of high-resolution imaging techniques. A delay in the diagnosis of malignant strictures may lead to a change in prognosis and unnecessary surgery in benign cases ( up to 15-24%). The aim of our study was to determine the usefulness of cholangioscopy to evaluate indeterminate biliary stricture and/or repletion defects suggestive of malignancy. We evaluated weather visual information, with or without pathological anatomy, leads to a change in patient management.

Methods Prospective, observational, single-centre study between 2016 and 2023. All patients with indeterminate biliary stricture who underwent ERCP-digital single operator cholangioscopy were included, Statistical analysis: the Fisher exact test was used for proportions and a P<0.05 was considered significant. The diagnostic performance of the visual impression to characterize stenosis (Mendoza visual classification), and to exclude intracholedocal lesions was evaluated.

Results Thirty-four cholangioscopies were performed in 34 patients. Technical success was 100%. Clinical management of patients: 9 cases underwent surgery for suspected malignancy (confirmed); 10 cases showed no intraductal lesions; 15 cases were benign strictures treated endoscopically with fully covered metal biliary stents. All patients had a minimum follow-up of 1 year. Visual findings were: stenosis suggestive of benignity 42%, absence of intraductal lesions 29.4%, irregular surface with/without ulceration 38.2%, dilated and tortuous vessels 35.3%, intraductal papillary projections 26.5%, surface disruption 23.5% and fibrosis 14.7%. The sensitivity of visual diagnosis was 90.9%, specificity 82.9%, positive predictive value (PPV) 71%, negative predictive value (NPV) 95%. Biopsies were performed in 73.5% of the cases and sufficient material was obtained for diagnosis in 96% of cases. The sensitivity of histology was 81%, the specificity of 100% and the positive predictive value of 100%. The strongest predictive criteria for malignancy were irregular surface (P<0.001) with PPV 100% and NPV 88.5%, followed by tortuous/anomalous vessels (P<0.001) with PPV 75% and NPV 91%.

Conclusions Cholangioscopy is very useful in the multidisciplinary diagnosis of indeterminate biliary strictures, with a high negative predictive value (95%). The presence of an irregular surface has a high positive predictive value (100%) to suspecting malignancy. The absence of anomalous vessels has a high negative predictive value (91%). Cholangioscopy may avoid unnecessary surgery and might fasten the diagnosis when malignancy is suspected by visual diagnosis alone.

Publication History

Article published online:
15 April 2024