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经内镜黏膜下剥离术与传统内镜黏膜切除术治疗无蒂结直肠病变的随机临床试验。

Underwater versus conventional EMR for nonpedunculated colorectal lesions: a randomized clinical trial.

机构信息

Instituto do Cancer do Estado de São Paulo, São Paulo, Brazil; Fleury Medicina e Saude, São Paulo, São Paulo, Brazil.

Instituto do Cancer do Estado de São Paulo, São Paulo, Brazil; Fleury Medicina e Saude, São Paulo, São Paulo, Brazil.

出版信息

Gastrointest Endosc. 2023 Mar;97(3):549-558. doi: 10.1016/j.gie.2022.10.033. Epub 2022 Oct 26.

Abstract

BACKGROUND AND AIMS

Conventional endoscopic mucosal resection (CEMR) is the standard modality for removing nonpedunculated colorectal lesions. Underwater endoscopic mucosal resection (UEMR) has emerged as an alternative method. There are few comparative studies between these techniques, especially evaluating recurrence. Therefore, the purpose of this trial was to compare CEMR and UEMR for the resection of colorectal lesions with respect to efficacy, safety, and recurrence rate.

METHODS

This was a randomized controlled trial of UEMR versus CEMR for naïve and nonpedunculated lesions measuring between 10 and 40 mm. The primary outcome was adenoma recurrence at 6 months after the resection. Secondary outcomes were rates of technical success, en bloc resection, and adverse events. Block randomization was used to assign patients. Tattooing was performed to facilitate localization of the scars and eventual recurrences. Endoscopic follow-up was scheduled at 6 months after the procedure. The sites of resections were examined with white-light imaging, narrow-band imaging (NBI), and conventional chromoscopy with indigo carmine followed by biopsies.

RESULTS

One hundred five patients with 120 lesions were included, with a mean size of 17.5 ± 7.1 (SD) mm. Sixty-one lesions were resected by UEMR and 59 by CEMR. The groups were similar at baseline regarding age, sex, average size, and histologic type. Lesions in the proximal colon in the CEMR group corresponded to 83% and in the UEMR group to 67.8% (P = .073). There was no difference between groups regarding success rate (1 failure in each group) and en bloc resection rate (60.6% UEMR vs 54.2% CEMR, P = .48). Intraprocedural bleeding was observed in 5 CEMRs (8.5%) and 2 UEMRs (3.3%) (P = .27). There was no perforation or delayed hemorrhage in either groups. Recurrence rate was higher in the CEMR arm (15%) than in the UEMR arm (2%) (P = .031). Therefore, the relative risk of 6-month recurrence rate in the CEMR group was 7.5-fold higher (95% CI, 0.98-58.20), with a number needed to treat of 7.7 (95% CI, 40.33-4.22). The higher recurrence rate in the CEMR group persisted only for lesions measuring 21 to 40 mm (35.7% vs 0%; P = .04).

CONCLUSION

This study demonstrated that UEMR was associated with a lower adenoma recurrence rate than was CEMR. Both endoscopic techniques were effective and had similar rates of adverse events for the treatment of nonpedunculated colorectal lesions.

摘要

背景与目的

传统内镜下黏膜切除术(CEMR)是切除非息肉状结直肠病变的标准方式。水下内镜下黏膜切除术(UEMR)已成为一种替代方法。这两种技术之间的比较研究很少,特别是在评估复发方面。因此,本试验的目的是比较 CEMR 和 UEMR 切除直径在 10 至 40 毫米之间的非息肉状结直肠病变的疗效、安全性和复发率。

方法

这是一项 UEMR 与 CEMR 治疗非息肉状、无蒂病变的随机对照试验,病变直径为 10 至 40 毫米。主要结局是切除后 6 个月时腺瘤复发。次要结局是技术成功率、整块切除率和不良事件发生率。采用区组随机化方法分配患者。对病变进行标记,以便于定位疤痕和可能的复发。内镜随访安排在术后 6 个月。用白光成像、窄带成像(NBI)和靛胭脂常规 chromoscopy 检查切除部位,然后进行活检。

结果

共纳入 105 例 120 处病变患者,平均直径为 17.5±7.1(SD)毫米。61 处病变采用 UEMR 切除,59 处病变采用 CEMR 切除。两组在基线时的年龄、性别、平均大小和组织学类型方面相似。CEMR 组的近端结肠病变占 83%,UEMR 组的病变占 67.8%(P=0.073)。两组的成功率(每组 1 例失败)和整块切除率(UEMR 组 60.6%,CEMR 组 54.2%,P=0.48)无差异。CEMR 组有 5 例(8.5%)和 UEMR 组有 2 例(3.3%)发生术中出血(P=0.27)。两组均无穿孔或迟发性出血。CEMR 组的复发率(15%)高于 UEMR 组(2%)(P=0.031)。因此,CEMR 组 6 个月时的复发率相对风险为 7.5 倍(95%CI,0.98-58.20),需要治疗的病例数为 7.7(95%CI,40.33-4.22)。CEMR 组仅在病变直径为 21 至 40 毫米时(35.7% vs 0%;P=0.04)复发率较高。

结论

本研究表明,与 CEMR 相比,UEMR 与较低的腺瘤复发率相关。两种内镜技术治疗非息肉状结直肠病变均有效,不良事件发生率相似。

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