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

Longer withdrawal times may yield similar neoplasia detection rates as found by HD chromoendoscopy.

更长的撤镜时间可能会产生与高清染色内镜相似的肿瘤检出率。

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.

为了比较高清白光内镜与分段复查和高清染色内镜在结直肠肿瘤检测率上的差异，将单次通过高清白光内镜作为额外的对照组。

Methods

In a multicentre, randomised controlled trial, IBD patients aged ≥18 years without active disease and scheduled for endoscopic surveillance were included.

在一个多中心、随机对照试验中，纳入了年龄≥18岁、无活动性炎症性肠病且计划进行内镜监测的患者。

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.

患者按照2:2:1的比例随机分为高清白光内镜检查组，每一段结肠进行分段复查（双次通过），高清染色内镜检查组或单次通过高清白光内镜检查组。

The primary outcome was colorectal neoplasia detection rate.

主要结果指标是结直肠肿瘤检出率。

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.

假设结直肠肿瘤发生率（非劣效性边界为10%）在节段性复查和染色内镜之间是相等的，且节段性复查优于单次通过高分辨率白光内镜，需要566名患者作为样本量。

Results

In total, 563 patients were analysed per-protocol.

总共，有563名患者按照方案进行了分析。

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.

结直肠肿瘤检出率在高清白光内镜分段复查中为10.3%（24/234），在高清染色内镜中为13.1%（28/214）。

This confirmed non-inferiority to HD chromoendoscopy (Δ-2.8%, lower limit 95% CI -7.8, p<0.01).

这证实了与高清染色内镜相比的非劣效性（Δ-2.8%，95%置信区间下限-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).

此外，每10分钟撤镜时间检测到的结直肠肿瘤数量在高清白光内镜结合分段复查和高清染色内镜之间相似（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).

单次通过高清白光内镜的结直肠肿瘤检出率较低（6.1%；n=7/115），与分段复查相比，但这种差异不具有统计学意义（Δ4.1%，95% 置信区间 -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.

高清晰白光内镜配合分段复查在炎症性肠病患者中对结直肠肿瘤的检测不劣于高清染色内镜。

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.

因此可以假设，高清染色内镜的益处可能是由于撤镜时间更长，而不一定是由于对比度增强。

However, re-inspection per se did not lead to a significantly higher colorectal neoplasia rate than single-pass HD white-light endoscopy alone.

然而，仅仅重复检查本身并没有导致结直肠肿瘤的发生率显著高于单次高清白光内镜检查。