Endoscopy Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Department of Endoscopy, NHO Shikoku Cancer Center, Matsuyama, Ehime, Japan.
Surg Endosc. 2022 Jan;36(1):515-525. doi: 10.1007/s00464-021-08311-6. Epub 2021 Feb 10.
Colorectal neoplastic lesions (≥ 20 mm) are commonly treated via piecemeal endoscopic mucosal resection (p-EMR) but have a high rate of local recurrence. We aimed to clarify the optimal surveillance interval after p-EMR for these neoplasias.
In this multicenter (15 participating institutions) prospective, randomized trial, 180 patients recruited over a 4-year period and were classified based on tumor location, tumor diameter, histological diagnosis, institution, and number of resected specimens. The patients underwent curative p-EMR followed by scheduled surveillance colonoscopy at 3, 6, 12, and 24 months after p-EMR (group A; n = 90) or at 6, 12, and 24 months after p-EMR (group B; n = 90). The primary endpoint was cumulative local recurrence at 6 months after p-EMR. Secondary endpoints included local recurrence and the cumulative surgical resection rate of recurrent tumors during the 24-month follow-up period.
The median tumor diameter was 25 mm (IQR 20-30). Six months after p-EMR, 12 and 6 local recurrences were noted in groups A and B, which corresponded to 13 and 8 recurrences, respectively, during the 24-month surveillance period. The primary and secondary endpoints of recurrence were not significantly different between the groups on either intention-to-treat or per-protocol analysis; no surgery case was observed in group B when a strict surveillance protocol of 6-, 12-, and 24-month follow-up post-EMR was followed.
For patients who underwent p-EMR for neoplastic lesions, additional postprocedural 3-month surveillance did not show superior results in detecting recurrence compared with a 6-month surveillance interval.
UMIN000015740.
结直肠肿瘤性病变（≥20mm）常采用分片内镜黏膜切除术（p-EMR）治疗，但局部复发率较高。本研究旨在明确此类肿瘤行 p-EMR 后的最佳随访间隔。
这是一项多中心（15 家参与机构）前瞻性随机试验，于 4 年内纳入 180 例患者，根据肿瘤位置、肿瘤直径、组织学诊断、机构和切除标本数量进行分类。所有患者行根治性 p-EMR 治疗，然后在 p-EMR 后 3、6、12 和 24 个月（A 组，n=90）或 p-EMR 后 6、12 和 24 个月（B 组，n=90）进行计划随访结肠镜检查。主要终点为 p-EMR 后 6 个月时的累积局部复发率。次要终点包括 24 个月随访期间的局部复发率和复发性肿瘤的累积手术切除率。
肿瘤直径中位数为 25mm（IQR 20-30）。p-EMR 后 6 个月，A 组和 B 组分别有 12 例和 6 例局部复发，在 24 个月的随访期间，分别有 13 例和 8 例复发。意向治疗和按方案分析的两组间复发的主要和次要终点均无显著差异；B 组严格遵循 EMR 后 6、12 和 24 个月的随访方案，未观察到手术病例。
对于接受 p-EMR 治疗的肿瘤性病变患者，与 6 个月的随访间隔相比，额外的术后 3 个月随访并未显示出在检测复发方面的优势。
UMIN000015740。
