Performance of a fully disposable, digital, single-operator cholangiopancreatoscope.

Our aim was to evaluate the first use in humans of a new, single-use, digital, single-operator intraductal cholangiopancreatoscopy system (IDCP).  Data were collected retrospectively from four US institutions between February 2015 and April 2015. The visual impression of neoplasia or benign findings with IDCP was determined by the performing endoscopist. High grade dysplasia, intraductal papillary mucinous neoplasm, neuroendocrine tumor, and malignancy were categorized as neoplasia. Benign disease was defined as the absence of neoplasia during ≥ 6 months of follow-up.  Patients (n = 108) with indeterminate strictures, dilatation, or difficult stones underwent IDCP. Of 74 patients with indeterminate stricture or dilatation, 29 (39 %) had neoplasia, of which 25 were confirmed by miniature biopsy forceps, 2 by surgical pathology, and 2 by the presence of metastatic disease on follow-up imaging. In patients with benign disease, 15 had concentric stenosis or normal/erythematous changes, 5 had low papillary mucosal projections, 6 had coarse granular mucosa, and 4 had nodular mucosa. Findings in patients with neoplastic disease included dilated, tortuous vessels ("tumor vessels"; n = 13), irregular margins with partial occlusion of the lumen (infiltrative stricture, n = 12), villous or nodular mass (n = 9), and finger-like villiform projections (n = 5). Operating characteristics for indeterminate stricture or dilatation were: 97 % sensitivity, 93 % specificity, 90 % positive predictive value, 98 % negative predictive value. Targeted biopsy yielded 86 % sensitivity and 100 % specificity. Stone clearance was noted in all cases. Adverse events occurred in 3 %.  The new IDCP system provides enhanced image resolution, and may improve the ability to target difficult stones and diagnose indeterminate strictures.