Department of Medicine, University of Florida College of Medicine, Gainesville, Florida 32610, USA.
Gastrointest Endosc. 2012 Feb;75(2):347-53. doi: 10.1016/j.gie.2011.09.020.
The diagnostic accuracy of cholangioscopy-guided sampling has not been rigorously evaluated.
To prospectively evaluate the accuracy of cholangioscopy-guided mini-forceps sampling and compare it with standard cytology brushings and forceps biopsies for the tissue diagnosis of indeterminate biliary lesions.
Prospective, long-term follow-up, paired design cohort study.
Tertiary center.
Patients undergoing cholangioscopy for the evaluation of indeterminate biliary lesions.
Each patient underwent triple sampling with cholangioscopy-guided mini-forceps, cytology brushing, and standard forceps.
Diagnostic accuracy of each sampling method compared with the patient final status (cancer vs no cancer).
A total of 26 patients (17 cancer positive/9 cancer negative) were enrolled. The mean follow-up in the patients with no cancer was 21.78 (SD ±6.78) months. The procedure was technically successful in all cases (100%). Sample quality was adequate in 25 of 26 (96.2%) of the cytology brushings, in 26 of 26 (100%) of the standard forceps biopsies, and in 25 of 26 (96.2%) of the mini-forceps biopsies. The sensitivity, accuracy, and negative predictive values were 5.9%, 38.5%, and 36% for standard cytology brushings; 29.4%, 53.8%, and 42.8% for standard forceps biopsies; and 76.5%, 84.6%, and 69.2% for mini-forceps biopsies, respectively. When comparing the 3 methods of sampling, mini-forceps biopsy provided significantly better sensitivity and overall accuracy compared with standard cytology brushing (P < .0001) and standard forceps biopsy (P = .0215).
Potential for selection bias.
Cholangioscopy-guided biopsies of indeterminate biliary lesions have significantly higher accuracy compared with ERCP-guided cytology brushings and standard forceps biopsies, but negative findings on mini-forceps biopsy cannot rule out malignancy with a high degree of certainty. (
NCT01227382.).
胆管镜引导下取样的诊断准确性尚未经过严格评估。
前瞻性评估胆管镜引导下迷你活检钳取样的准确性，并将其与标准细胞学刷检和活检钳活检进行比较，用于诊断不确定的胆道病变的组织学诊断。
前瞻性、长期随访、配对设计队列研究。
三级中心。
因不确定的胆道病变而行胆管镜检查的患者。
每位患者均接受胆管镜引导下迷你活检钳、细胞学刷检和标准活检钳的三联取样。
每种取样方法与患者最终状态（癌症阳性/阴性）的诊断准确性比较。
共纳入 26 例患者（17 例癌症阳性/9 例癌症阴性）。无癌症患者的中位随访时间为 21.78（SD ±6.78）个月。所有病例均成功完成了该操作（100%）。26 例中的 25 例（96.2%）细胞学刷检标本质量充足，26 例中的 26 例（100%）标准活检钳活检标本质量充足，26 例中的 25 例（96.2%）迷你活检钳活检标本质量充足。标准细胞学刷检的敏感性、准确性和阴性预测值分别为 5.9%、38.5%和 36%；标准活检钳活检分别为 29.4%、53.8%和 42.8%；迷你活检钳活检分别为 76.5%、84.6%和 69.2%。与标准细胞学刷检和标准活检钳活检相比，迷你活检钳活检在敏感性和总准确性方面具有显著优势（P＜0.0001 和 P=0.0215）。
存在选择偏倚的可能性。
与 ERCP 引导下的细胞学刷检和标准活检钳活检相比，胆管镜引导下活检对不确定的胆道病变具有更高的准确性，但迷你活检钳活检阴性不能高度确定排除恶性肿瘤。（临床试验注册号：NCT01227382）。
