BACKGROUND & AIMS Although single-operator cholangioscopy is considered to be the most sensitive method for tissue acquisition in patients with indeterminate bile duct strictures (IBDS), methods are needed to optimize the specimen collection and processing techniques. We aimed to determine the optimal method for specimen processing and identify the number of biopsies required to establish a definitive diagnosis. METHODS Patients with IBDS were randomly assigned to groups that underwent specimen processing using the onsite (n = 32) or offsite (n = 30) method. The primary outcome was to compare operating characteristics of onsite vs offsite specimen processing techniques. The secondary outcome was number of biopsies needed to establish definitive diagnosis. A final diagnosis was established at surgery or after a minimum clinical follow-up period of 18 months RESULTS: The final diagnosis was benign disease in 33 patients and malignancy in 29 patients. There were no significant differences between the offsite and onsite groups in diagnostic accuracy (90% vs 87.5%; P=.99), sensitivity (76.9% vs 75%; P=.99), specificity (100% vs 100%; P=.99), positive predictive value (100% vs 100%; P=.99), or negative predictive value (85% vs 80%; P=.99). Although diagnoses were established by analysis of a median of 1 biopsy in the onsite cohort (interquartile range, 1-1.5), the diagnostic accuracy was identical (90%) in each group, regardless of whether 3 or 4 biopsies were collected from each patient in the offsite cohort. CONCLUSIONS In a prospective comparative study, we found that centers without onsite cytopathology support that analyze 3 single-operator cholangioscopy-guided biopsies of a biliary stricture and process the specimens offsite make the correct diagnosis for 90% of cases. ClinicalTrials.gov, Number: NCT01815619.

中文翻译：

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基于随机试验优化单人胆管镜引导活检的结果。

背景和目的 虽然单人胆管镜被认为是不确定胆管狭窄 (IBDS) 患者组织采集的最敏感方法，但仍需要优化标本采集和处理技术的方法。我们旨在确定标本处理的最佳方法，并确定建立明确诊断所需的活检数量。方法 IBDS 患者被随机分配到使用现场（n = 32）或异地（n = 30）方法进行标本处理的组。主要结果是比较现场与非现场标本处理技术的操作特性。次要结果是建立明确诊断所需的活检数量。最终诊断是在手术或至少 18 个月的临床随访期后确定的 结果：最终诊断为 33 名患者的良性疾病和 29 名患者的恶性疾病。非现场组和现场组在诊断准确性（90% 对 87.5%；P=.99）、敏感性（76.9% 对 75%；P=.99）、特异性（100% 对 100%；P =.99)、阳性预测值（100% 对 100%；P=.99）或阴性预测值（85% 对 80%；P=.99）。尽管通过分析现场队列中 1 次活检的中位数（四分位距，1-1.5）来确定诊断，但每组的诊断准确度相同 (90%)，无论是从每位患者收集 3 次还是 4 次活检在异地队列中。结论 在一项前瞻性比较研究中，我们发现，没有现场细胞病理学支持的中心对 90% 的病例进行了正确的诊断，这些中心分析了 3 次单人胆管镜引导下的胆道狭窄活检并在异地处理标本。ClinicalTrials.gov，编号：NCT01815619。