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日本一项前瞻性、多中心队列研究:内镜黏膜下剥离术治疗大肠大型上皮性肿瘤的长期疗效。

Long-term Outcomes After Endoscopic Submucosal Dissection for Large Colorectal Epithelial Neoplasms: A Prospective, Multicenter, Cohort Trial From Japan.

机构信息

Department of Gastroenterology, NTT Medical Center, Tokyo, Japan.

Department of Gastroenterology, Tochigi Cancer Center, Utsunomiya, Japan; Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.

出版信息

Gastroenterology. 2022 Nov;163(5):1423-1434.e2. doi: 10.1053/j.gastro.2022.07.002. Epub 2022 Jul 8.

DOI:10.1053/j.gastro.2022.07.002
PMID:35810779
Abstract

BACKGROUND & AIMS: To determine the long-term outcomes after colorectal endoscopic submucosal dissection (ESD), we conducted a large, multicenter, prospective cohort trial with a 5-year observation period.

METHODS

Between February 2013 and January 2015, we consecutively enrolled 1740 patients with 1814 colorectal epithelial neoplasms ≥20 mm who underwent ESD. Patients with noncurative resection (non-CR) lesions underwent additional radical surgery, as needed. After the initial treatment, intensive 5-year follow-up with planned multiple colonoscopies was conducted to identify metastatic and/or local recurrences. Primary outcomes were overall survival, disease-specific survival, and intestinal preservation rates. The rates of local recurrence and metachronous invasive cancer were evaluated as the secondary outcomes.

RESULTS

The 5-year overall survival, disease-specific survival, and intestinal preservation rates were 93.6%, 99.6%, and 88.6%, respectively. Patients with CR lesions had no metastatic occurrence, and patients with non-CR lesions had 4 metastatic occurrences. Kaplan-Meier curves revealed that overall survival and disease-specific survival rates were significantly higher in patients with CR lesions than in those with non-CR lesions (P > .001 and P = .009, respectively). Local recurrence occurred in only 8 lesions (0.5%), which were successfully resected by subsequent endoscopic treatment. Multiple logistic regression analyses revealed that piecemeal resection (hazard ratio, 8.19; 95% CI, 1.47-45.7; P = .02) and margin-positive resection (hazard ratio, 8.06; 95% CI, 1.76-37.0; P = .007) were significant independent predictors of local recurrence after colorectal ESD. Fifteen metachronous invasive cancers (1.0%) were identified during surveillance colonoscopy, most of which required surgical resection.

CONCLUSIONS

A favorable long-term prognosis indicates that ESD can be the standard treatment for large colorectal epithelial neoplasms.

CLINICAL TRIAL REGISTRATION NUMBER

UMIN000010136.

摘要

背景与目的

为了确定结直肠内镜黏膜下剥离术(ESD)后的长期预后,我们进行了一项大型、多中心、前瞻性队列研究,观察期为 5 年。

方法

在 2013 年 2 月至 2015 年 1 月期间,我们连续纳入了 1740 例接受 ESD 的直径≥20mm 的大肠上皮性肿瘤患者,共 1814 个病灶。非治愈性切除(非-CR)病变的患者需要额外进行根治性手术。初始治疗后,通过计划中的多次结肠镜检查进行强化的 5 年随访,以确定转移和/或局部复发情况。主要结局为总生存率、疾病特异性生存率和肠道保留率。局部复发和异时性侵袭性癌的发生率被评估为次要结局。

结果

5 年总生存率、疾病特异性生存率和肠道保留率分别为 93.6%、99.6%和 88.6%。CR 病变患者无转移发生,非-CR 病变患者有 4 例转移发生。Kaplan-Meier 曲线显示,CR 病变患者的总生存率和疾病特异性生存率显著高于非-CR 病变患者(P<.001 和 P=.009)。仅 8 例(0.5%)出现局部复发,通过后续内镜治疗成功切除。多因素逻辑回归分析显示,分片切除(危险比,8.19;95%可信区间,1.47-45.7;P=.02)和边缘阳性切除(危险比,8.06;95%可信区间,1.76-37.0;P=.007)是结直肠 ESD 后局部复发的显著独立预测因素。在监测性结肠镜检查中发现了 15 例异时性侵袭性癌症(1.0%),其中大多数需要手术切除。

结论

良好的长期预后表明 ESD 可以作为大肠上皮性肿瘤的标准治疗方法。

临床试验注册号

UMIN000010136。

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