Kyushu University, Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Fukuoka, Japan.
Kyushu University, Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Fukuoka, Japan; Kyushu University, Department of Gastroenterology and Metabolism, Graduate School of Medical Sciences, Fukuoka City, Japan.
Clin Gastroenterol Hepatol. 2023 Jul;21(7):1810-1818.e8. doi: 10.1016/j.cgh.2022.10.030. Epub 2022 Nov 5.
BACKGROUND & AIMS: Hybrid endoscopic submucosal dissection (H-ESD), which incorporates endoscopic submucosal dissection (ESD) with endoscopic mucosal resection, has been developed to make ESD technically easier. This study aimed to determine if H-ESD is superior to conventional ESD (C-ESD) for small early gastric neoplasms (EGNs).
We conducted a multi-center, prospective, open-label, randomized controlled trial to compare the treatment outcomes of H-ESD and C-ESD (Hybrid-G Trial). Patients with differentiated type intramucosal EGN ≤20 mm in diameter and without ulceration were randomly assigned (1:1) to groups that underwent H-ESD or C-ESD. A single multi-functional snare, SOUTEN (ST1850-20, Kaneka, Medix, Tokyo, Japan), was used for H-ESD. The primary outcome was procedure time. Secondary outcomes included mucosal incision time, time and speed of submucosal dissection, curability, and endoscopic procedural adverse events.
A total of 39 and 40 patients underwent H-ESD and C-ESD, respectively. The procedure time of H-ESD was significantly shorter than that of C-ESD (33.16 min vs 62.46 min; H-ESD/C-ESD ratio: 0.53; 95% confidence interval, 0.41-0.69; P < .0001). There was no significant difference in mucosal incision time between the 2 groups; the time and speed of submucosal dissection of H-ESD were significantly shorter than those of C-ESD. No difference was observed between the 2 groups in other outcomes.
H-ESD has significantly shorter procedure time than C-ESD, with high and comparable curability and safety for both H-ESD and C-ESD. H-ESD can be a good option for the endoscopic treatment of small EGNs. (UMIN Clinical Trials Registry, Numbers: UMIN000041244).
为使内镜黏膜下剥离术（ESD）更具技术操作性，将其与内镜黏膜切除术结合形成了混合内镜黏膜下剥离术（H-ESD）。本研究旨在明确 H-ESD 治疗小直径早期胃癌（EGN）是否优于传统 ESD（C-ESD）。
我们开展了一项多中心、前瞻性、开放标签、随机对照试验，比较 H-ESD 与 C-ESD（Hybrid-G 试验）的治疗结局。将无溃疡的直径≤20 mm、分化型黏膜内 EGN 患者按 1∶1 随机分配至行 H-ESD 或 C-ESD 的两组。采用多功能结扎圈（SOUTEN，ST1850-20，Kaneka，Medix，Tokyo，日本）进行 H-ESD。主要结局为操作时间。次要结局包括黏膜切开时间、黏膜下剥离时间和速度、根治性和内镜操作不良事件。
共有 39 例患者行 H-ESD，40 例患者行 C-ESD。H-ESD 的操作时间显著短于 C-ESD（33.16 min 比 62.46 min；H-ESD/C-ESD 比值：0.53；95%置信区间：0.41~0.69；P＜0.0001）。两组黏膜切开时间无显著差异；H-ESD 的黏膜下剥离时间和速度显著短于 C-ESD。两组其他结局无差异。
与 C-ESD 相比，H-ESD 的操作时间显著缩短，且 H-ESD 和 C-ESD 的根治率和安全性相当。H-ESD 可作为治疗小直径 EGN 的一种有效内镜治疗方法。（UMIN 临床试验注册编号：UMIN000041244）
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