Gastroenterology and Hepatology, Amsterdam UMC Location University of Amsterdam, Amsterdam, The Netherlands.
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
Surg Endosc. 2023 Jun;37(6):4566-4573. doi: 10.1007/s00464-023-09916-9. Epub 2023 Feb 27.
Endoscopic retrograde cholangiopancreatography (ERCP) with biliary brush cytology is commonly used to diagnose malignant pancreatobiliary strictures. This trial compared the sensitivity of two intraductal brush cytology devices.
A randomized controlled trial in which consecutive patients with suspected malignant, extrahepatic biliary strictures were randomized (1:1) to a dense or conventional brush cytology device. Primary endpoint was sensitivity. Interim analysis was conducted after 50% of the patients completed follow-up. Results were interpreted by a data safety monitoring board.
Between June 2016 and June 2021, 64 patients were randomized to the dense (27 patients, 42%) or conventional brush (37 patients, 58%). Malignancy was diagnosed in 60 patients (94%) and benign disease in 4 patients (6%). Diagnoses were confirmed by histopathology in 34 patients (53%), cytopathology in 24 patients (38%), and clinical or radiological follow up in 6 patients (9%). Sensitivity of the dense brush was 50%, compared to 44% for the conventional brush (p = 0·785).
The results of this randomized controlled trial showed that the sensitivity of a dense brush is not superior to a conventional brush for diagnosing malignant extrahepatic pancreatobiliary strictures. This trial was prematurely ended for reasons of futility.
Netherlands Trial Register number; NTR5458.
经内镜逆行胰胆管造影（ERCP）联合胆管刷检细胞学检查常用于诊断恶性胰胆管狭窄。本试验比较了两种胆管内刷检细胞学设备的敏感性。
这是一项随机对照试验，连续入组怀疑恶性、肝外胆道狭窄的患者，按照 1:1 比例随机分配至密集型或常规型刷检细胞学设备组。主要终点为敏感性。在 50%的患者完成随访后进行中期分析。结果由数据安全监测委员会解读。
2016 年 6 月至 2021 年 6 月，64 例患者被随机分配至密集型（27 例，42%）或常规型刷检组（37 例，58%）。60 例（94%）患者诊断为恶性疾病，4 例（6%）为良性疾病。34 例（53%）患者通过组织病理学、24 例（38%）通过细胞学、6 例（9%）通过临床或影像学随访确诊。密集型刷检的敏感性为 50%，常规型刷检为 44%（p=0.785）。
本随机对照试验结果表明，对于诊断恶性肝外胰胆管狭窄，密集型刷检的敏感性并不优于常规型刷检。本试验因无效而提前终止。
荷兰临床试验注册中心编号：NTR5458。
