Dedicated endoscopy for Barrett’s esophagus randomized blinded pilot study: comparing a dedicated Barrett’s surveillance service with standard care

iGIE Pub Date : 2024-03-01 DOI:10.1016/j.igie.2023.11.003
Elizabeth Ratcliffe PhD , James Britton PhD , Richard Keld MD , Shaheen Hamdy PhD , John McLaughlin PhD , Yeng Ang MD
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Abstract

Background and Aims

Barrett’s esophagus endoscopic surveillance is prone to poor guideline adherence. This study was undertaken to obtain pilot data comparing standard care with a dedicated Barrett’s endoscopy service.

Methods

Adults with nondysplastic Barrett’s esophagus at 2 sites in the northwest of England were randomized to a dedicated service versus a nondedicated service for their routine surveillance. On the dedicated arm, 64% were male; 72% in the nondedicated arm were male. Median ages were 66 years and 63 years in the dedicated and nondedicated arms, and mean Prague circumferential length was 2 cm and 3 cm, respectively. The dedicated service was performed by endoscopists trained in Barrett’s assessment on specific sessions. Data were obtained on dysplasia detection and adherence to British Society of Gastroenterology guidelines.

Results

Of 111 recruited cases (80% recruitment rate), 92 underwent endoscopy (39 were correctly performed on the dedicated arm and 25 on the nondedicated arm). In the dedicated arm, 5 (13%) cases of dysplasia were found; 2 (8%) cases of dysplasia were found in the nondedicated arm. Guideline adherence was better in the dedicated arm, particularly Prague classification documentation (37 of 39 [95%] vs 20 of 25 [80%]) and Seattle protocol adherence (34 of 39 [87%] vs 15 of 25 [60%]). Post hoc analysis with χ2 test showed improved Seattle protocol adherence (34 of 37 dedicated vs 15 of 24 nondedicated, P = .005), visible lesion documentation (37 of 38 dedicated vs 12 of 23 nondedicated, P ≤ .001), and use of targeted biopsies (25 of 39 dedicated vs 3 of 25, nondedicated P ≤ .001).

Conclusions

This study is the first pilot randomized trial of dedicated services versus non-dedicated services for Barrett’s surveillance. It shows that the study design is feasible and informs a future powered multicenter study. (Clinical trial registration number: ISRCTN12259569.)

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巴雷特食管专用内镜检查随机盲法试点研究:比较巴雷特食管专用监测服务与标准护理方法
背景和目的巴雷特食管内镜监测容易出现指南遵守率低的问题。本研究旨在获得标准护理与巴雷特内镜专科服务的试验性比较数据。方法在英格兰西北部的两个地点,患有非增生性巴雷特食管的成人被随机分配到专科服务与非专科服务进行常规监测。在专用服务组中,64% 为男性;在非专用服务组中,72% 为男性。专用组和非专用组的中位年龄分别为 66 岁和 63 岁,布拉格周长的平均值分别为 2 厘米和 3 厘米。专职服务由接受过巴雷特评估培训的内镜医师在特定时段进行。结果 111例招募病例(招募率为80%)中,92例接受了内镜检查(39例在专用组正确实施,25例在非专用组正确实施)。专用组发现了 5 例(13%)发育不良病例;非专用组发现了 2 例(8%)发育不良病例。专用组对指南的遵守情况更好,尤其是布拉格分类记录(39 例中的 37 例 [95%] vs 25 例中的 20 例 [80%])和西雅图方案的遵守情况(39 例中的 34 例 [87%] vs 25 例中的 15 例 [60%])。用 χ2 检验进行的事后分析表明,西雅图方案的依从性(37 位专职者中的 34 位 vs 24 位非专职者中的 15 位,P = .005)、可见病灶记录(38 位专职者中的 37 位 vs 23 位非专职者中的 12 位,P ≤ .001)和靶向活检的使用(39 位专职者中的 25 位 vs 25 位非专职者中的 3 位,P ≤ .001)均有所改善。该研究表明,研究设计是可行的,并为未来的有动力多中心研究提供了参考。(临床试验注册号:ISRCTN12259569)。
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