Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Lombardia, Italy.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Digestive Endoscopy Unit, Roma, Lazio, Italy; Università Cattolica del Sacro Cuore Facoltà di Medicina e Chirurgia, Centre for Endoscopic Research Therapeutics and Training (CERTT), Roma, Lazio, Italy.
Dig Liver Dis. 2024 May;56(5):847-852. doi: 10.1016/j.dld.2023.11.017. Epub 2023 Nov 27.
Characterization of indeterminate biliary strictures (IDBS) still represents a major challenge. Digital single-operator cholangioscopy (DSOC) could potentially overcome limits of conventional biopsy and brush sampling. The aim of this study was to compare diagnostic accuracy of visual evaluation and DSOC-guided biopsies to conventional trans-papillary sampling techniques and to evaluate the inter-observer agreement (IOA) on visual diagnosis.
All consecutive patients undergoing DSOC-guided biopsy after conventional sampling techniques for IDBS during a six-year period were retrospectively evaluated. Final diagnosis was based on histological evaluation of the surgical specimen if available or a clinical follow-up of at least 6 months. For IOA, 20-second DSOC clips were retrospectively reviewed by 6 experts and 6 trainees and classified according to the Monaco Classification.
Thirty-five patients underwent DSOC for IDBS in the study period; 14 patients (F = 9) with a median age of 64 years (range 53-76) met the study aim. After DSOC, strictures location was changed in three patients (additional yield of 21.4 %). Intraductal DSOC-guided biopsy were technically successful in all cases, with an adequacy of 92.8 %. No adverse events were recorded. Final diagnosis was benign disease in five cases and cholangiocarcinoma in the others. For IOA, 29 videos were evaluated with almost perfect agreement for final diagnosis (kappa 0.871; agreement 93.1, p <0.001), although overall accuracy of DSOC visual finding was 73.6 % and 64.4 % for experts and trainees, respectively.
DSOC could improve diagnostic accuracy for IDBS, since it showed high sensitivity for visual finding and high specificity for DSOC guided-biopsy. Visual diagnosis seems reliable for diagnosis using the Monaco Classification.
对不确定的胆道狭窄（IDBS）进行特征描述仍然是一个主要的挑战。数字单操作员胆管镜（DSOC）有可能克服传统活检和刷子采样的局限性。本研究的目的是比较视觉评估和 DSOC 引导下活检与传统经乳头采样技术的诊断准确性，并评估视觉诊断的观察者间一致性（IOA）。
回顾性评估了在六年期间因 IDBS 接受 DSOC 引导下活检的所有连续患者，这些患者在接受常规采样技术后。如果有手术标本的组织学评估，则基于最终诊断；如果没有，则进行至少 6 个月的临床随访。对于 IOA，由 6 名专家和 6 名学员回顾性地回顾了 20 秒的 DSOC 片段，并根据 Monaco 分类进行分类。
在研究期间，有 35 名患者因 IDBS 接受了 DSOC 检查；14 名患者（F = 9），中位年龄 64 岁（范围 53-76 岁）符合研究目的。在 DSOC 之后，有 3 名患者的狭窄部位发生了变化（额外检出率为 21.4%）。所有病例的胆管内 DSOC 引导活检均成功完成，充分性为 92.8%。无不良事件发生。最终诊断为 5 例良性疾病，其余为胆管癌。对于 IOA，评估了 29 个视频，最终诊断的一致性几乎为完美（kappa 0.871；一致性 93.1%，p <0.001），尽管专家和学员的 DSOC 视觉发现的总体准确性分别为 73.6%和 64.4%。
DSOC 可以提高对 IDBS 的诊断准确性，因为它对视觉发现具有较高的敏感性，对 DSOC 引导下的活检具有较高的特异性。使用 Monaco 分类进行诊断时，视觉诊断似乎是可靠的。
