Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Clinical Support Center, Wakayama Medical University, Wakayama, Japan.
Medicine (Baltimore). 2022 Apr 1;101(13):e29172. doi: 10.1097/MD.0000000000029172.
Endoscopic submucosal dissection (ESD) is an advanced therapeutic technique for en bloc resection of superficial gastrointestinal neoplasms. Although gastric ESD is minimally invasive and provides favorable outcomes, it is technically difficult and requires a long procedure time for dissection. The traction-assisted approach overcomes some of the difficulties of gastric ESD, but its ability to reduce the procedure time remains unclear. The traction-assisted approach using dental floss and a clip did not reduce procedure time in the total population, but it reduced procedure time for lesions limited to the greater curvature of the upper or middle of the stomach. Although the traction direction of the clip-with-line method may be limited to the oral side via the cardia, EndoTrac ESD may provide flexible traction at any time during the procedure. This prospective randomized control study has been designed to compare the efficacy and safety of EndoTrac and conventional gastric ESD.
METHODS/DESIGN: This multicenter, randomized control trial will enroll 150 patients at 2 hospitals in Japan undergoing EndoTrac or conventional ESD for gastric epithelial neoplasia. Patients with a single gastric epithelial neoplasm who meet the inclusion and exclusion criteria will be randomized to EndoTrac or conventional ESD. Patients will be randomized by a computer-generated random sequence with stratification by operator experience, tumor size, tumor location, and institution. The primary endpoint will be ESD procedure time, defined as the time from the start of the submucosal injection to the completion of resection. Other outcomes will include the rates of adverse events and pathological curability.
The ability of EndoTrac ESD to reduce the long procedure time and/or adverse events observed with conventional ESD can not only reduce physical stress on the patient, but can also reduce length of hospital stay and medical costs. Reduced technical difficulty will contribute to the widespread adoption of this ESD technique worldwide.
University Hospital Medial Information Network Clinical Trials Registry (UMIN-CTR), ID: 000044450; Registered on June 6, 2021.https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050485.
1.1, March 1, 2022. Patient enrolment began on June 6, 2021 and is expected to be completed by July 19, 2025.
内镜黏膜下剥离术（ESD）是一种用于整块切除胃肠道表面肿瘤的先进治疗技术。尽管胃 ESD 具有微创性且能获得良好的治疗效果，但它在技术上具有难度，且需要较长的手术时间来进行剥离。牵引辅助方法克服了胃 ESD 的一些困难，但它是否能缩短手术时间仍不清楚。在整个人群中，使用牙线和夹子的牵引辅助方法并没有缩短手术时间，但对于局限于胃上或中 1/3 大弯侧的病变，它可以缩短手术时间。虽然夹子拉线法的牵引方向可能仅限于贲门的口腔侧，但 EndoTrac ESD 可能在手术过程中的任何时候提供灵活的牵引。本前瞻性随机对照研究旨在比较 EndoTrac 和常规胃 ESD 的疗效和安全性。
方法/设计：这项多中心、随机对照试验将在日本的 2 家医院纳入 150 名接受 EndoTrac 或常规 ESD 治疗胃上皮性肿瘤的患者。符合纳入和排除标准的单个胃上皮性肿瘤患者将被随机分为 EndoTrac 或常规 ESD 组。患者将通过计算机生成的随机序列、按操作者经验、肿瘤大小、肿瘤位置和机构进行分层进行随机分组。主要终点是 ESD 手术时间，定义为从黏膜下注射开始到切除完成的时间。其他结局包括不良事件和病理完全缓解率。
EndoTrac ESD 能够缩短与常规 ESD 相关的较长手术时间和/或不良事件，不仅可以减轻患者的身体负担，还可以缩短住院时间和医疗费用。技术难度的降低将有助于该 ESD 技术在全球范围内的广泛应用。
大学医院医学信息网临床试验注册（UMIN-CTR），ID：000044450；注册于 2021 年 6 月 6 日。https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050485。
1.1，2022 年 3 月 1 日。患者招募于 2021 年 6 月 6 日开始，预计于 2025 年 7 月 19 日完成。
