Helmy Ahmed, Saad Eldien Heba Mohamed, Seifeldein Gehan Sayed, Abu-Elfatth Ahmed Mohammed, Mohammed Adnan Ahmed
Department of Tropical Medicine and Gastroenterology, Faculty of Medicine, Assiut University, Assiut, Egypt.
Department of Histology and Cell Biology, Faculty of Medicine, Assiut University, Assiut, Egypt.
J Clin Exp Hepatol. 2021 Mar-Apr;11(2):209-218. doi: 10.1016/j.jceh.2020.07.009. Epub 2020 Jul 26.
BACKGROUND & AIM: Conventional cytological evaluation (CCE) fails to identify nature indeterminate biliary duct stricture (IBDS) in many cases. Digital image analysis (DIA) has the ability to identify and analyze the DNA content of cells. This study assesses the role of DIA in recognizing the nature of IBDS compared to CCE.
A prospective observational study was conducted at the Al-Rajhi University Hospital. Fifty patients with IBDS, based on abdominal imaging, were subjected to endoscopic retrograde cholangiopancreatography (ERCP) and brush sampling. These samples were evaluated with CCE and DIA. Follow-up for at least 9 months and cost-analysis had also been done.
Based on the final diagnosis, 32 (64.0%) patients had malignant stricture, and 39 (78.0%) had distal stricture. DIA had 84.40% (95% CI; 67.20-94.70) sensitivity and 94.40% (95% CI; 72.70-99.90) specificity in identifying nature of IBDS, whereas CCE had 19.0% (95% CI; 7.20-36.40) sensitivity and 89.0% (95% CI; 65.30-98.60) specificity. Combination of both modalities had 84.40% (95% CI; 67.20-94.70) sensitivity and 83.30% (95% CI; 58.60-96.40) specificity in identification nature of IBDS. Based on CCE alone, only 6/32 (18.80%) of malignant stricture were diagnosed, and 26/32 (81.20%) were missed. However, DIA alone was able to diagnose 27/32 (84.40%) of malignant stricture, and only 5 cases were missed. Both procedures had detection rate of malignant stricture as DIA alone. Benign stricture was correctly diagnosed in 16/18 (88.80%), 17/18 (94.40%), and 15/18 (83.30%) using CCE alone, DIA alone, and both procedures together, respectively. Cost per detection additional one malignant stricture using DIA required 99.4$.
DIA is substantially better than CCE in diagnosing the nature of IBDS but at an increase cost and thus suggests its application in a wider role in clinical practice.
NCT04112030.
传统细胞学评估（CCE）在许多情况下无法识别性质不明的胆管狭窄（IBDS）。数字图像分析（DIA）能够识别和分析细胞的DNA含量。本研究评估了DIA与CCE相比在识别IBDS性质方面的作用。
在拉吉大学医院进行了一项前瞻性观察研究。50例基于腹部影像学诊断为IBDS的患者接受了内镜逆行胰胆管造影（ERCP）和刷检取样。这些样本采用CCE和DIA进行评估。同时进行了至少9个月的随访和成本分析。
根据最终诊断，32例（64.0%）患者为恶性狭窄，39例（78.0%）为远端狭窄。DIA在识别IBDS性质方面的灵敏度为84.40%（95%CI；67.20 - 94.70），特异度为94.40%（95%CI；72.70 - 99.90），而CCE的灵敏度为19.0%（95%CI；7.20 - 36.40），特异度为89.0%（95%CI；65.30 - 98.60）。两种方法联合使用在识别IBDS性质方面的灵敏度为84.40%（95%CI；67.20 - 94.70），特异度为83.30%（95%CI；58.60 - 96.40）。仅基于CCE，32例恶性狭窄中仅诊断出6例（18.80%），漏诊26例（81.20%）。然而，仅DIA就能诊断出32例恶性狭窄中的27例（84.40%），仅漏诊5例。两种方法对恶性狭窄的检出率与单独使用DIA相同。单独使用CCE、单独使用DIA以及两种方法联合使用时，分别正确诊断出良性狭窄的比例为16/18（88.80%）、17/18（94.40%）和15/18（83.30%）。使用DIA额外检测出一例恶性狭窄的成本为99.4美元。
在诊断IBDS性质方面，DIA明显优于CCE，但成本有所增加，因此建议其在临床实践中发挥更广泛的作用。
NCT04112030。
