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临床验证风险评分系统以预测大肠大病变内镜黏膜切除术后出血延迟的风险。

Clinical validation of risk scoring systems to predict risk of delayed bleeding after EMR of large colorectal lesions.

机构信息

Complejo Hospitalario de Navarra, Pamplona, Spain.

Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.

出版信息

Gastrointest Endosc. 2020 Apr;91(4):868-878.e3. doi: 10.1016/j.gie.2019.10.013. Epub 2019 Oct 23.

Abstract

BACKGROUND AND AIMS

The Endoscopic Resection Group of the Spanish Society of Endoscopy (GSEED-RE) model and the Australian Colonic Endoscopic Resection (ACER) model were proposed to predict delayed bleeding (DB) after EMR of large superficial colorectal lesions, but neither has been validated. We validated and updated these models.

METHODS

A multicenter cohort study was performed in patients with nonpedunculated lesions ≥20 mm removed by EMR. We assessed the discrimination and calibration of the GSEED-RE and ACER models. Difficulty performing EMR was subjectively categorized as low, medium, or high. We created a new model, including factors associated with DB in 3 cohort studies.

RESULTS

DB occurred in 45 of 1034 EMRs (4.5%); it was associated with proximal location (odds ratio [OR], 2.84; 95% confidence interval [CI], 1.31-6.16), antiplatelet agents (OR, 2.51; 95% CI, .99-6.34) or anticoagulants (OR, 4.54; 95% CI, 2.14-9.63), difficulty of EMR (OR, 3.23; 95% CI, 1.41-7.40), and comorbidity (OR, 2.11; 95% CI, .99-4.47). The GSEED-RE and ACER models did not accurately predict DB. Re-estimation and recalibration yielded acceptable results (GSEED-RE area under the curve [AUC], .64 [95% CI, .54-.74]; ACER AUC, .65 [95% CI, .57-.73]). We used lesion size, proximal location, comorbidity, and antiplatelet or anticoagulant therapy to generate a new model, the GSEED-RE2, which achieved higher AUC values (.69-.73; 95% CI, .59-.80) and exhibited lower susceptibility to changes among datasets.

CONCLUSIONS

The updated GSEED-RE and ACER models achieved acceptable prediction levels of DB. The GSEED-RE2 model may achieve better prediction results and could be used to guide the management of patients after validation by other external groups. (Clinical trial registration number: NCT03050333.).

摘要

背景与目的

西班牙内镜学会内镜切除术组(GSEED-RE)模型和澳大利亚结肠内镜切除术(ACER)模型被提出用于预测大肠黏膜下大病变内镜切除术后延迟性出血(DB),但尚未经过验证。本研究旨在验证和更新这些模型。

方法

采用多中心队列研究,纳入 1034 例接受内镜黏膜切除术(EMR)切除的非息肉样病变≥20mm 的患者。评估 GSEED-RE 和 ACER 模型的区分度和校准度。内镜切除难度主观分为低、中和高。创建一个新模型,纳入了 3 项队列研究中与 DB 相关的因素。

结果

DB 发生于 1034 例 EMR 中的 45 例(4.5%);与近端位置(比值比 [OR],2.84;95%置信区间 [CI],1.31-6.16)、抗血小板药物(OR,2.51;95% CI,.99-6.34)或抗凝药物(OR,4.54;95% CI,2.14-9.63)、内镜切除难度(OR,3.23;95% CI,1.41-7.40)和并存疾病(OR,2.11;95% CI,.99-4.47)相关。GSEED-RE 和 ACER 模型不能准确预测 DB。重新估算和重新校准后结果可接受(GSEED-RE 曲线下面积 [AUC],.64 [95% CI,.54-.74];ACER AUC,.65 [95% CI,.57-.73])。我们使用病变大小、近端位置、并存疾病以及抗血小板或抗凝治疗生成了一个新模型,即 GSEED-RE2,该模型的 AUC 值更高(.69-.73;95% CI,.59-.80),并且在数据集之间的变化方面的敏感性更低。

结论

更新后的 GSEED-RE 和 ACER 模型可实现 DB 预测的可接受水平。GSEED-RE2 模型可能会获得更好的预测结果,并且在经过其他外部团体验证后可用于指导患者的管理。(临床试验注册号:NCT03050333.)

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