Xu Ming, Yang Jing-Yi, Meng Tao
Department of Colorectal Surgery, Qilu Hospital (Qingdao), Cheeloo College of Medicine, Qingdao 266000, Shandong Province, China.
Department of Gastrointestinal Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, Henan Province, China.
World J Gastrointest Surg. 2024 Jul 27;16(7):2270-2280. doi: 10.4240/wjgs.v16.i7.2270.
Colorectal cancer (CRC) is one of the most common malignant tumors, and early screening is crucial to improving the survival rate of patients. The combination of colonoscopy and immune fecal occult blood detection has garnered significant attention as a novel method for CRC screening. Colonoscopy and fecal occult blood tests, when combined, can improve screening accuracy and early detection rates, thereby facilitating early intervention and treatment. However, certain risks and costs accompany it, making the establishment of a risk classification model crucial for accurate classification and management of screened subjects.
To evaluate the feasibility and effectiveness of colonoscopy, immune fecal occult blood test (FIT), and risk-graded screening strategies in CRC screening.
Based on the randomized controlled trial of CRC screening in the population conducted by our hospital May 2020 to May 2023, participants who met the requirements were randomly assigned to a colonoscopy group, an FIT group, or a graded screening group at a ratio of 1:2:2 (after risk assessment, the high-risk group received colonoscopy, the low-risk group received an FIT test, and the FIT-positive group received colonoscopy). The three groups received CRC screening with different protocols, among which the colonoscopy group only received baseline screening, and the FIT group and the graded screening group received annual follow-up screening based on baseline screening. The primary outcome was the detection rate of advanced tumors, including CRC and advanced adenoma. The population participation rate, advanced tumor detection rate, and colonoscopy load of the three screening programs were compared.
A total of 19373 subjects who met the inclusion and exclusion criteria were enrolled, including 8082 males (41.7%) and 11291 females (58.3%). The mean age was 60.05 ± 6.5 years. Among them, 3883 patients were enrolled in the colonoscopy group, 7793 in the FIT group, and 7697 in the graded screening group. Two rounds of follow-up screening were completed in the FIT group and the graded screening group. The graded screening group (89.2%) and the colonoscopy group (42.3%) had the lowest overall screening participation rates, while the FIT group had the highest (99.3%). The results of the intentional analysis showed that the detection rate of advanced tumors in the colonoscopy group was greater than that of the FIT group [2.76% 2.17%, odds ratio (OR) = 1.30, 95% confidence interval (CI): 1.01-1.65, = 0.037]. There was no significant difference in the detection rate of advanced tumors between the colonoscopy group and the graded screening group (2.76% 2.35%, OR = 1.9, 95%CI: 0.93-1.51, = 0.156), as well as between the graded screening group and the FIT group (2.35% 2.17%, OR = 1.09%, 95%CI: 0.88-1.34, = 0.440). The number of colonoscopy examinations required for each patient with advanced tumors was used as an index to evaluate the colonoscopy load during population screening. The graded screening group had the highest colonoscopy load (15.4 times), followed by the colonoscopy group (10.2 times), and the FIT group had the lowest (7.8 times).
A hierarchical screening strategy based on CRC risk assessment is feasible for screening for CRC in the population. It can be used as an effective supplement to traditional colonoscopy and FIT screening programs.
结直肠癌（CRC）是最常见的恶性肿瘤之一，早期筛查对于提高患者生存率至关重要。结肠镜检查与免疫粪便潜血检测相结合作为一种新型的CRC筛查方法受到了广泛关注。结肠镜检查和粪便潜血检测联合使用可提高筛查准确性和早期检出率，从而便于早期干预和治疗。然而，其伴随着一定风险和成本，因此建立风险分类模型对于准确分类和管理筛查对象至关重要。
评估结肠镜检查、免疫粪便潜血检测（FIT）以及风险分级筛查策略在CRC筛查中的可行性和有效性。
基于我院2020年5月至2023年5月在人群中开展的CRC筛查随机对照试验，将符合要求的参与者按1:2:2的比例随机分配至结肠镜检查组、FIT检查组或分级筛查组（风险评估后，高危组接受结肠镜检查，低危组接受FIT检测，FIT阳性组接受结肠镜检查）。三组采用不同方案进行CRC筛查，其中结肠镜检查组仅接受基线筛查，FIT检查组和分级筛查组在基线筛查基础上接受年度随访筛查。主要结局指标为进展期肿瘤（包括CRC和进展性腺瘤）的检出率。比较三个筛查方案的人群参与率、进展期肿瘤检出率和结肠镜检查负担。
共纳入19373名符合纳入和排除标准的受试者，其中男性8082名（41.7%），女性11291名（58.3%）。平均年龄为60.05±6.5岁。其中，结肠镜检查组3883例，FIT检查组7793例，分级筛查组7697例。FIT检查组和分级筛查组完成了两轮随访筛查。分级筛查组（89.2%）和结肠镜检查组（42.3%）的总体筛查参与率最低，而FIT检查组最高（99.3%）。意向性分析结果显示，结肠镜检查组进展期肿瘤检出率高于FIT检查组[2.76%对2.17%，比值比（OR）=1.30，95%置信区间（CI）：1.01 - 1.65，P = 0.037]。结肠镜检查组与分级筛查组进展期肿瘤检出率无显著差异（2.76%对2.35%，OR = 1.9，95%CI：0.93 - 1.51，P = 0.156），分级筛查组与FIT检查组之间也无显著差异（2.35%对2.17%，OR = 1.09%，95%CI：0.88 - 1.34，P = 0.440）。将每名进展期肿瘤患者所需的结肠镜检查次数作为评估人群筛查期间结肠镜检查负担的指标。分级筛查组的结肠镜检查负担最高（15.4次），其次是结肠镜检查组（10.2次），FIT检查组最低（7.8次）。
基于CRC风险评估的分级筛查策略在人群CRC筛查中是可行的。它可作为传统结肠镜检查和FIT筛查方案的有效补充。
