Ribbing Wilén Hanna, Blom Johannes, Höijer Jonas, Andersson Gaya, Löwbeer Christian, Hultcrantz Rolf
a Department of Clinical Science, Intervention and Technology , Karolinska Institutet , Stockholm , Sweden.
b Trauma and Reparative Medicine, Division of Emergency Surgery , Karolinska University Hospital Huddinge , Stockholm , Sweden.
Scand J Gastroenterol. 2019 Mar;54(3):303-310. doi: 10.1080/00365521.2019.1585569. Epub 2019 Mar 23.
Fecal immunochemical test (FIT) is used in colorectal cancer (CRC) screening, but evaluations of multiple sample strategies in colonoscopy screening cohorts are rare. The aim of this study was to assess accuracy of FIT for advanced neoplasia (AN) with two fecal samples in a colonoscopy screening cohort. The study comprised 1155 participants of the colonoscopy arm in SCREESCO (Screening of Swedish Colons, NCT02078804), a randomized controlled study on CRC screening of 60-year-olds from the Swedish average-risk population. Participants provided two FIT samples prior to colonoscopy. First sample, mean of two, and any of the two samples above cut off level were assessed. Colonoscopy findings (CRC, advanced adenoma (AA), AN (CRC + AA) and adenoma characteristics) were evaluated in uni- and multivariable analysis in relation to FIT positivity (at ≥10 µg hemoglobin (Hb)/g). Of 1155 invited, 806 (416 women, 390 men) participated. CRC, AA and non-AA were found in one (0.1%), 80 (9.9%) and 145 (18%), respectively. Sensitivity and specificity for AN were 20%/93%, 25%/92% and 26%/89% for first, mean of two and any of the two samples respectively at cut off level 10 µg/g, corresponding to 60 (74%)-65 (80%) participants with missed AN. The difference in sensitivity between screening strategies was non-significant. The specificity for first sample was significantly higher than for any of the two samples at cut off 10 µg/g ( = .02) and 20 µg/g ( = .04). FIT positivity in participants with adenoma was associated with pedunculated shape ( = .007) and high-risk dysplasia ( = .009). In an average-risk colonoscopy screening cohort of 60-year-olds, sensitivity for AN was modest and did not increase when using two samples instead of one. FIT predominantly detected adenomas with pedunculated shape and high-risk dysplasia, and participants with flat or broad based adenomas may thus be missed in screening.
粪便免疫化学检测（FIT）用于结直肠癌（CRC）筛查，但在结肠镜筛查队列中对多种样本策略的评估却很少见。本研究的目的是在结肠镜筛查队列中评估两次粪便样本检测FIT对进展期瘤变（AN）的准确性。该研究纳入了SCREESCO（瑞典结肠筛查，NCT02078804）中结肠镜检查组的1155名参与者，这是一项针对瑞典平均风险人群中60岁人群进行CRC筛查的随机对照研究。参与者在结肠镜检查前提供两份FIT样本。评估了第一份样本、两份样本的均值以及两份样本中任何一份高于临界值的情况。在单变量和多变量分析中，将结肠镜检查结果（CRC、高级别腺瘤（AA）、AN（CRC + AA）和腺瘤特征）与FIT阳性（血红蛋白（Hb）≥10μg/g）相关联进行评估。在1155名受邀者中，806人（416名女性，390名男性）参与。分别发现1例（0.1%）CRC、80例（9.9%）AA和145例（18%）非AA。在临界值为10μg/g时，第一份样本、两份样本的均值以及两份样本中任何一份对AN的敏感性分别为20%/93%、25%/92%和26%/89%，这相当于60（74%） - 65（80%）名参与者的AN被漏检。筛查策略之间的敏感性差异无统计学意义。在临界值为10μg/g（P = 0.02）和20μg/g（P = 0.04）时，第一份样本的特异性显著高于两份样本中的任何一份。腺瘤患者的FIT阳性与有蒂形态（P = 0.007）和高危发育异常（P = 0.009）相关。在一个60岁的平均风险结肠镜筛查队列中，AN的敏感性适中，使用两份样本而非一份样本时敏感性并未增加。FIT主要检测出有蒂形态和高危发育异常的腺瘤，因此在筛查中可能会漏诊扁平或广基腺瘤的患者。
