Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial-猫眼课题宝

DOI：

10.1016/s0140-6736(20)31099-0

发表时间：

2020-08-01

期刊：

LANCET

影响因子：

168.9

通讯作者：

中科院分区：

医学1区

文献类型：

作者：

Fitzgerald, Rebecca C.;di Pietro, Massimiliano;Sasieni, Peter

背景：Barrett‘s食道发育不良的治疗可防止进展为腺癌；然而，Barrett’s食道的最佳诊断策略尚不清楚。细胞三叶因子3(TFF3)是Barrett‘s食道的非内窥镜检测。这项研究的目的是调查与标准治疗相比，向服用胃食道反流药物的患者提供这项测试是否会增加Barrett‘s食道的检测。方法这项多中心、实用、随机的对照试验在英国109家社会人口统计学差异较大的全科诊所进行。在全科诊所水平(整群随机化)和个体患者水平上都进行了随机化，每种随机化的结果在合并之前分别进行了分析。如果患者年龄在50岁或以上，因胃食道反流症状服用抑酸剂超过6个月，并且在过去5年内未接受内窥镜检查，则符合条件。全科诊所是由当地临床研究网络挑选出来的，并被邀请参加试验。对于整群随机化，临床由试验统计师使用计算机生成的随机序列随机分配(1：1)；对于个体患者水平的随机化，患者由全科诊所使用中央准备的计算机生成的随机序列随机分配(1：1)。随机后，参与者接受胃食道反流的标准治疗(常规护理组)，其中参与者只有在全科医生要求的情况下才接受内窥镜检查，或者常规护理加提供Cytosponge-TFF3程序，如果程序发现TFF3阳性细胞，则随后进行内窥镜检查(干预组)。主要结果是在登记后12个月诊断出Barrett‘s食道，以每1000人年的发病率表示，与常规护理组的所有参与者相比，干预组的所有参与者(无论他们是否接受了Cytosponge-TFF3手术的提议)。分析是意向治疗。该试验在ISRCTN注册中心注册，ISRCTN68382401，并已完成。在2017年3月20日至2019年3月21日期间，113家全科诊所参加了试验，但有4家诊所在随机分组后不久退出。我们利用电脑搜寻余下109间诊所的电子处方记录，找出13 657名合资格的病人，并在14天内向他们发出介绍信，让他们选择退出。其中13514名患者被随机分配到常规护理组(n=6531)或干预组(n=6983)。随机化后，干预组6983名参与者中的149名(2%)和常规护理组6531名参与者中的143名(2%)在进一步检查后，不符合所有资格标准或退出研究。在干预组的其余6834名参与者中，2679名(39%)表示有兴趣接受Cytosponge-TFF3手术。在这些人中，1750人(65%)符合电话筛查的所有资格标准，并接受了这一程序。这些参与者中的大多数(1654[95%]；中位年龄69岁)成功地吞咽了细胞染色体并产生了样本。在6834名参与者中，有231人(3%)的细胞学检查结果为阳性，并被转诊为内窥镜检查。拒绝接受Cytosponge-TFF3手术的患者和常规护理组的所有参与者只有在全科医生认为必要时才进行内窥镜检查。在平均12个月的随访中，干预组6834名参与者中有140名(2%)和13名(

Background Treatment of dysplastic Barrett's oesophagus prevents progression to adenocarcinoma; however, the optimal diagnostic strategy for Barrett's oesophagus is unclear. The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus. The aim of this study was to investigate whether offering this test to patients on medication for gastro-oesophageal reflux would increase the detection of Barrett's oesophagus compared with standard management.Methods This multicentre, pragmatic, randomised controlled trial was done in 109 socio-demographically diverse general practice clinics in England. Randomisation was done both at the general practice clinic level (cluster randomisation) and at the individual patient level, and the results for each type of randomisation were analysed separately before being combined. Patients were eligible if they were aged 50 years or older, had been taking acid-suppressants for symptoms of gastro-oesophageal reflux for more than 6 months, and had not undergone an endoscopy procedure within the past 5 years. General practice clinics were selected by the local clinical research network and invited to participate in the trial. For cluster randomisation, clinics were randomly assigned (1:1) by the trial statistician using a computer-generated randomisation sequence; for individual patient-level randomisation, patients were randomly assigned (1:1) by the general practice clinics using a centrally prepared computer-generated randomisation sequence. After randomisation, participants received either standard management of gastro-oesophageal reflux (usual care group), in which participants only received an endoscopy if required by their general practitioner, or usual care plus an offer of the Cytosponge-TFF3 procedure, with a subsequent endoscopy if the procedure identified TFF3-positive cells (intervention group). The primary outcome was the diagnosis of Barrett's oesophagus at 12 months after enrolment, expressed as a rate per 1000 person-years, in all participants in the intervention group (regardless of whether they had accepted the offer of the Cytosponge-TFF3 procedure) compared with all participants in the usual care group. Analyses were intention-to-treat. The trial is registered with the ISRCTN registry, ISRCTN68382401, and is completed.Findings Between March 20, 2017, and March 21, 2019, 113 general practice clinics were enrolled, but four clinics dropped out shortly after randomisation. Using an automated search of the electronic prescribing records of the remaining 109 clinics, we identified 13 657 eligible patients who were sent an introductory letter with 14 days to opt out. 13 514 of these patients were randomly assigned (per practice or at the individual patient level) to the usual care group (n=6531) or the intervention group (n=6983). Following randomisation, 149 (2%) of 6983 participants in the intervention group and 143 (2%) of 6531 participants in the usual care group, on further scrutiny, did not meet all eligibility criteria or withdrew from the study. Of the remaining 6834 participants in the intervention group, 2679 (39%) expressed an interest in undergoing the Cytosponge-TFF3 procedure. Of these, 1750 (65%) met all of the eligibility criteria on telephone screening and underwent the procedure. Most of these participants (1654 [95%]; median age 69 years) swallowed the Cytosponge successfully and produced a sample. 231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy. Patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner. During an average of 12 months of follow-up, 140 (2%) of 6834 participants in the intervention group and 13 (

Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial

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