PDF(Pubmed)
Abstract：
Introduction: Colorectal cancer has a high prevalence and mortality rate in the United Kingdom. Cancerous colorectal lesions often bleed into the gastrointestinal lumen. The faecal immunochemical test (FIT) detects haemoglobin (Hb) in the faeces of patients and is used as a first line test in the diagnosis of colorectal cancer. Materials and Methods: A retrospective audit of all FIT performed and all colorectal cancers diagnosed in the Hull and East Riding of Yorkshire counties of the United Kingdom (population approximately 609,300) between 2018 and 2022 was conducted. FIT were performed using a HM-JACKarc analyser from Kyowa medical. The predominant symptom suggestive of colorectal cancer which prompted the FIT was recorded. Colorectal cancer was diagnosed using the gold standard of histological biopsy following colonoscopy. Results: Between 2018 and 2022, 56,202 FIT were performed on symptomatic patients. Follow on testing identified 1,511 with colorectal cancer. Of these people, only 450 people with a confirmed colorectal cancer had a FIT within the 12 months preceding their diagnosis. Of these 450 FIT results, 36 had a concentration of <10 μg/g and may be considered to be a false negative. The sensitivity of FIT in the patients identified was 92.00%. The most common reason stated by the clinician for a FIT being performed in patients with colorectal cancer was a change in bowel habits, followed by iron deficient anaemia. The number of patients diagnosed with colorectal cancer decreased in 2020, but increased significantly in 2021. Discussion: This study shows that 8.00% of people diagnosed with colorectal cancer in the Hull and East Riding of Yorkshire regions had a negative FIT. This study also shows that the SARS-CoV-2 pandemic affected the number of people diagnosed with colorectal cancer, and therefore skews the prevalence and pre-test probability of a positive test. There are many reasons why a FIT could produce a false negative result, the most likely being biological factors affecting the stability of haemoglobin within the gastrointestinal tract, or pre-analytical factors influencing faecal sampling preventing the detection of haemoglobin. Some colorectal lesions do not protrude into the gastrointestinal lumen and are less likely to bleed. Conclusion: This is the first study showing data from outside of a structured clinical trial and provides the largest study to date showing the sensitivity of FIT in a routine clinical setting. This study also provides evidence for the impact COVID-19 had on the rate of colorectal cancer diagnosis.
摘要：
简介：结直肠癌在英国有很高的患病率和死亡率。结直肠癌性病变常流入胃肠腔。粪便免疫化学测试（FIT）可检测患者粪便中的血红蛋白（Hb），并用作诊断结直肠癌的一线测试。材料和方法：对2018年至2022年间在英国约克郡的赫尔和东骑术（人口约609,300）进行的所有FIT和所有结直肠癌进行了回顾性审计。FIT使用Kyowamedical的HM-JACKarc分析仪进行。记录提示提示FIT的结直肠癌的主要症状。结肠镜检查后，使用组织学活检的金标准诊断结直肠癌。结果：在2018年至2022年之间，对有症状的患者进行了56,202次FIT。随后的测试确定1,511患有结直肠癌。在这些人中,只有450例确诊结直肠癌患者在确诊前12个月内获得FIT.在这450个FIT结果中，36具有<10μg/g的浓度并且可以被认为是假阴性。FIT在患者中的敏感性为92.00%。临床医生对大肠癌患者进行FIT的最常见原因是排便习惯的改变，其次是缺铁性贫血。2020年诊断为结直肠癌的患者数量有所减少，但在2021年显著增加。讨论：这项研究表明，在约克郡的赫尔和东骑马地区，8.00％的人被诊断患有结直肠癌，FIT为阴性。这项研究还表明，SARS-CoV-2大流行影响了被诊断患有结直肠癌的人数，并因此扭曲了阳性测试的患病率和测试前概率。FIT可能会产生假阴性结果的原因有很多，最有可能是影响胃肠道内血红蛋白稳定性的生物因素，或影响粪便采样的分析前因素，阻止血红蛋白的检测。一些结直肠病变不突出到胃肠腔中并且不太可能出血。结论：这是第一个显示来自结构化临床试验之外的数据的研究，并且提供了迄今为止最大的研究，显示了FIT在常规临床环境中的敏感性。这项研究还为COVID-19对结直肠癌诊断率的影响提供了证据。
