Surveillance in inflammatory bowel disease: white light endoscopy with segmental re-inspection versus dye-based chromoendoscopy – a multi-arm randomised controlled trial (HELIOS)

IF 23 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Gut Pub Date : 2025-01-16 DOI:10.1136/gutjnl-2024-333446
Maarten te Groen, Anouk M Wijnands, Nathan den Broeder, Dirk J de Jong, Willemijn A van Dop, Marjolijn Duijvestein, Herma H Fidder, Fiona van Schaik, Meike M C Hirdes, Andrea E van der Meulen-de Jong, P W Jeroen Maljaars, Philip W Voorneveld, K H Nanne de Boer, Charlotte P Peters, Bas Oldenburg, Frank Hoentjen
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Abstract

Background It remains unclear if the increased colorectal neoplasia detection rate in inflammatory bowel disease (IBD) by high-definition (HD) dye-based chromoendoscopy compared with HD white-light endoscopy is due to enhanced contrast or increased inspection times. Longer withdrawal times may yield similar neoplasia detection rates as found by HD chromoendoscopy. Objective To compare colorectal neoplasia detection rates for HD white-light endoscopy with segmental re-inspection and HD chromoendoscopy, using single-pass HD white-light endoscopy as an additional control group. Design In a multicentre, randomised controlled trial, IBD patients aged ≥18 years without active disease and scheduled for endoscopic surveillance were included. Patients were 2:2:1 randomised to HD white-light endoscopy with segmental re-inspection of each colonic segment (double pass), HD chromoendoscopy or single-pass HD white-light endoscopy. The primary outcome was colorectal neoplasia detection rate. Assuming equal colorectal neoplasia rates (non-inferiority margin of 10%) between segmental re-inspection and chromoendoscopy and superiority of segmental re-inspection vs single-pass HD white-light endoscopy, a sample size of 566 patients was required. Results In total, 563 patients were analysed per-protocol. Colorectal neoplasia detection rates were 10.3% (n=24/234) for HD white-light endoscopy with segmental re-inspection and 13.1% (n=28/214) for HD chromoendoscopy. This confirmed non-inferiority to HD chromoendoscopy (Δ−2.8%, lower limit 95% CI −7.8, p<0.01). In addition, the number of detected colorectal neoplasia per 10 min of withdrawal time was similar between HD white-light endoscopy with segmental re-inspection and HD chromoendoscopy (0.062 vs 0.058, p=0.83). Single-pass HD white-light endoscopy yielded a lower colorectal neoplasia rate (6.1%; n=7/115) than segmental re-inspection but this was not statistically significant (Δ4.1%, 95% CI −2.2:9.6%, p=0.19). Conclusions HD white-light endoscopy with segmental re-inspection was non-inferior to HD chromoendoscopy for colorectal neoplasia detection in IBD patients. It can therefore be assumed that the benefit of HD chromoendoscopy may be explained by the longer withdrawal time and not necessarily the enhanced contrast. However, re-inspection per se did not lead to a significantly higher colorectal neoplasia rate than single-pass HD white-light endoscopy alone. Data are available upon reasonable request. The data that support the findings of this study are available on request from the corresponding author [F.H].
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炎症性肠病的监测:白光内镜与节段性复查与染料染色内镜——一项多组随机对照试验(HELIOS)
背景:与高清白光内镜相比,高清晰度(HD)染色内镜在炎症性肠病(IBD)中结肠肿瘤检出率的增加是由于对比度增强还是检查次数增加,目前尚不清楚。较长的停药时间可能产生与HD色内窥镜相似的肿瘤检出率。目的比较HD白光内镜下节段复查与HD显色内镜下结直肠肿瘤的检出率,并以单次HD白光内镜为对照组。在一项多中心随机对照试验中,纳入年龄≥18岁且无活动性疾病且计划进行内镜监测的IBD患者。患者以2:2:1随机分组,分别接受高清白光内镜检查,并对每一结肠段进行节段复查(双通道)、高清彩色内镜检查或单通道高清白光内镜检查。主要观察指标为结直肠肿瘤检出率。假设节段复查与彩色内镜的结直肠肿瘤发生率相等(非劣效边际为10%),节段复查优于单次高清白光内镜,需要566例患者的样本量。结果按方案共分析563例患者。结直肠肿瘤检出率,HD白光内镜段段复查10.3% (n=24/234), HD色光内镜13.1% (n=28/214)。这证实了HD色镜检查的非劣效性(Δ−2.8%,下限95% CI−7.8,p<0.01)。此外,HD白光内镜段段复查与HD彩色内镜每10 min检出的结直肠肿瘤数量相似(0.062 vs 0.058, p=0.83)。单次高清白光内镜检查显示结直肠肿瘤发生率较低(6.1%;n=7/115),但这在统计学上不显著(Δ4.1%, 95% CI−2.2:9.6%,p=0.19)。结论HD白光内镜下节段复查在IBD患者结肠肿瘤检查中的应用不低于HD彩色内镜。因此,可以假设高清彩色内窥镜的好处可能是由于较长的退出时间,而不一定是增强的对比度。然而,复查本身并没有导致结直肠肿瘤发生率明显高于单次高清白光内镜检查。如有合理要求,可提供资料。支持本研究结果的数据可向通讯作者索取[F.H]。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Gut
Gut 医学-胃肠肝病学
CiteScore
45.70
自引率
2.40%
发文量
284
审稿时长
1.5 months
期刊介绍: Gut is a renowned international journal specializing in gastroenterology and hepatology, known for its high-quality clinical research covering the alimentary tract, liver, biliary tree, and pancreas. It offers authoritative and current coverage across all aspects of gastroenterology and hepatology, featuring articles on emerging disease mechanisms and innovative diagnostic and therapeutic approaches authored by leading experts. As the flagship journal of BMJ's gastroenterology portfolio, Gut is accompanied by two companion journals: Frontline Gastroenterology, focusing on education and practice-oriented papers, and BMJ Open Gastroenterology for open access original research.
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