Vineet Kumar, Tripathi Mayank, Kumar Chandan, Singh Satyendra Narayan, Srivastava Akash, Gill Gurupreet Singh, Shukla Piyush Kant, Kumar Barun
Department of Surgical Oncology, MPMMCC & HBCH, Tata Memorial Centre, Homi Bhabha National Institute, Varanasi, India.
Department of Radiodiagnosis, MPMMCC & HBCH, Tata Memorial Centre, Homi Bhabha National Institute, Varanasi, India.
J Gastrointest Cancer. 2025 Sep 16;56(1):189. doi: 10.1007/s12029-025-01317-6.
Gallbladder cancer is a highly aggressive malignancy with disproportionate incidence in the Gangetic belt of India. Early diagnosis is critical yet most patients present with advanced-stage disease. Serum tumor markers like CEA and Ca 19.9 are often elevated in gallbladder cancer, but their role in rapidly triaging patients for metastatic disease at presentation has not been prospectively validated in prospective cohort.
This sub-analysis is part of a larger prospective observational study conducted at a tertiary cancer center in North India. A total of 1500 newly diagnosed, treatment-naïve or incidental gallbladder cancer patients were enrolled between September 2023 and May 2024. Serum CEA and Ca 19.9 levels were measured at baseline. Diagnostic thresholds were derived using the 75th percentile values stratified by obstructive jaundice status. Diagnostic accuracy for predicting metastatic disease was assessed using confusion matrices, ROC curves, and precision-recall analysis.
Of 1500 patients, 1203 (80.2%) presented with metastatic disease. Serum data were available for 1011 patients. Patients with metastatic disease had significantly higher marker levels (CEA: mean 288.4 vs. 22.9 ng/mL; Ca 19.9: 20,917 vs. 2241 U/mL). The model showed high specificity (89.1%) and positive predictive value (92.3%) with moderate AUC (0.74). Sensitivity was limited (40.3%), suggesting strong "rule-in" but weak "rule-out" capability.
Elevated serum CEA and Ca 19.9 adjusted for jaundice status are strong indicators of metastatic gallbladder cancer at presentation. This real-world percentile-based approach offers a rapid, low-cost diagnostic adjunct for early triage in resource-limited settings. The findings provide context-sensitive thresholds that may aid timely treatment decisions in high-burden regions.
胆囊癌是一种侵袭性很强的恶性肿瘤，在印度恒河地区的发病率不成比例。早期诊断至关重要，但大多数患者就诊时已处于晚期疾病阶段。血清肿瘤标志物如癌胚抗原（CEA）和糖类抗原19-9（Ca 19.9）在胆囊癌中常升高，但其在患者就诊时快速筛选转移性疾病方面的作用尚未在前瞻性队列中得到前瞻性验证。
该亚分析是在印度北部一家三级癌症中心进行的一项更大规模前瞻性观察性研究的一部分。2023年9月至2024年5月期间，共纳入1500例新诊断、未接受过治疗或偶然发现的胆囊癌患者。在基线时测量血清CEA和Ca 19.9水平。诊断阈值通过按梗阻性黄疸状态分层的第75百分位数得出。使用混淆矩阵、ROC曲线和精确召回分析评估预测转移性疾病的诊断准确性。
1500例患者中，1203例（80.2%）就诊时已有转移性疾病。1011例患者有血清数据。有转移性疾病的患者标志物水平显著更高（CEA：平均288.4 vs. 22.9 ng/mL；Ca 19.9：20917 vs. 2241 U/mL）。该模型显示出高特异性（89.1%）和阳性预测值（92.3%），AUC中等（0.74）。敏感性有限（40.3%），表明“纳入”能力强但“排除”能力弱。
根据黄疸状态调整后的血清CEA和Ca 19.9升高是胆囊癌就诊时发生转移的有力指标。这种基于现实世界百分位数的方法为资源有限环境下的早期分诊提供了一种快速、低成本的诊断辅助手段。研究结果提供了与背景相关的阈值，可能有助于高负担地区及时做出治疗决策。
