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采用“切除并丢弃”策略进行光学诊断的临床实践:DISCARD3 研究。

Implementation of optical diagnosis with a "resect and discard" strategy in clinical practice: DISCARD3 study.

机构信息

Wolfson Unit for Endoscopy, St Mark's Hospital, Harrow, London, UK.

Pathology Department, St Mark's Hospital, Harrow, London, UK.

出版信息

Gastrointest Endosc. 2022 Dec;96(6):1021-1032.e2. doi: 10.1016/j.gie.2022.06.019. Epub 2022 Jun 18.

DOI:10.1016/j.gie.2022.06.019
PMID:35724693
Abstract

BACKGROUND AND AIMS

Optical diagnosis (OD) of polyps can be performed with advanced endoscopic imaging. For high-confidence diagnoses, a "resect and discard" strategy could offer significant histopathology time and cost savings. The implementation threshold is a ≥90% OD-histology surveillance interval concordance. Here we assessed the OD learning curve and feasibility of a resect and discard strategy for ≤5-mm and <10-mm polyps in a bowel cancer screening setting.

METHODS

In this prospective feasibility study, 8 bowel cancer screening endoscopists completed a validated OD training module and performed procedures. All <10-mm consecutive polyps had white-light and narrow-band images taken and were given high- or low-confidence diagnoses until 120 high-confidence ≤5-mm polyp diagnoses had been performed. All polyps had standard histology. High-confidence OD errors underwent root-cause analysis. Histology and OD-derived surveillance intervals were calculated.

RESULTS

Of 565 invited patients, 525 patients were included. A total of 1560 <10-mm polyps underwent OD and were resected and retrieved (1329 ≤5 mm and 231 6-9 mm). There were no <10-mm polyp cancers. High-confidence OD was accurate in 81.5% of ≤5-mm and 92.8% of 6-9-mm polyps. Sensitivity for OD of a ≤5-mm adenoma was 93.0% with a positive predictive value of 90.8%. OD-histology surveillance interval concordance for ≤5-mm OD was 91.3% (209/229) for U.S. Multi-Society Task Force, 98.3% (225/229) for European Society of Gastrointestinal Endoscopy, and 98.7% (226/229) for British Society of Gastroenterology guidelines, respectively.

CONCLUSIONS

A resect and discard strategy for high-confidence ≤5-mm polyp OD in a group of bowel cancer screening colonoscopists is feasible and safe, with performance exceeding the 90% surveillance interval concordance required for implementation in clinical practice. (Clinical trial registration number: NCT04710693.).

摘要

背景和目的

光学诊断(OD)可用于高级内镜成像。为了进行高可信度的诊断,“切除并丢弃”策略可以显著节省组织病理学的时间和成本。实施的门槛是 OD-组织学监测间隔的一致性≥90%。在此,我们评估了在结直肠癌筛查环境中,对≤5mm 和<10mm 息肉进行 OD 学习曲线和“切除并丢弃”策略的可行性。

方法

在这项前瞻性可行性研究中,8 名结直肠癌筛查内镜医生完成了一个经过验证的 OD 培训模块并进行了操作。所有<10mm 的连续息肉都进行了白光和窄带成像,并进行了高或低可信度的诊断,直到完成 120 个高可信度的≤5mm 息肉诊断。所有息肉均进行了标准组织学检查。高可信度的 OD 错误进行了根本原因分析。计算了组织学和 OD 衍生的监测间隔。

结果

在邀请的 565 名患者中,525 名患者入选。共对 1560 个<10mm 的息肉进行了 OD 并进行了切除和回收(1329 个≤5mm 和 231 个 6-9mm)。没有<10mm 的息肉癌症。81.5%的≤5mm 和 92.8%的 6-9mm 息肉的高可信度 OD 是准确的。OD 对≤5mm 腺瘤的敏感性为 93.0%,阳性预测值为 90.8%。≤5mm 的 OD 与美国多学会工作组的组织学监测间隔一致性为 91.3%(209/229),与欧洲胃肠道内镜学会的一致性为 98.3%(225/229),与英国胃肠病学会的指南的一致性为 98.7%(226/229)。

结论

在一组结直肠癌筛查结肠镜医生中,对高可信度的≤5mm 息肉 OD 采用“切除并丢弃”策略是可行且安全的,其性能超过了在临床实践中实施所需的 90%监测间隔一致性。(临床试验注册号:NCT04710693。)

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