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首页> 外文期刊>Surgical Endoscopy >Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial)
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Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial)

机译：具有GFTRD-SYSTEM的内镜全厚切除胃耻骨上肿瘤：一项预期试验研究（重置试验）

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Background Gastric subepithelial tumors (SET) are rare and usually benign. However, up to 13% are malignant. Histology after conventional biopsy often is inconclusive. Surveillance endoscopies are the consequence in the majority of gastric SET cases. For SET arising from deeper layers endoscopic resection (ER) with the standard techniques is difficult and associated with the risk of perforation. The RESET trial further evaluates feasibility, efficacy and safety of clip-assisted endoscopic full-thickness resection (EFTR) for gastric SET using the novel gastric full-thickness-resection device (gFTRD). Materials and methods The RESET trial was initiated in March 2017 (NCT03096236) and designed as prospective observational multicenter pilot trial. Gastric SET up to 15 mm were included. Primary endpoint was technical success (complete enbloc resection). Secondary endpoints were R0 resection, full-thickness resection, adverse events and recurrency at 3-months follow-up. For resection we used the gFTRD (Ovesco Endoscopy, Tubingen, Germany). Results 29 patients underwent gastric EFTR. Histology prior EFTR after conventional biopsy could define histological tumor type in only 31.2%. Primary endpoint was reached in 89.7%. Histology of the full-thickness-resection specimen could define histological tumor type in 100%. 76% of all SET could be resected histologically complete (R0) and a full-thickness-resection specimen could be obtained in 65.5%. In 31% periprocedural minor bleeding was observed and managed endoscopically. Follow-up was available in 79.3% (OTSC detachment in 78.3%, OTSC in position in 21.7%). No signs of residual or recurrent tumors were observed after 3 months. Conclusion EFTR of gastric SET with gFTRD is feasible and safe. EFTR allows a definite histological diagnosis (including sufficient risk stratification in case of GIST or NET) in contrast to conventional biopsy. R0-resection is possible in most cases and might obviate the need for further surveillance endoscopies for selected patients.
机译：背景技术胃耻骨上肿瘤（设定）是罕见的，通常是良性的。但是，高达13％是恶性的。常规活检后的组织学通常不确定。监测内窥镜是大多数胃设定病例的结果。对于从更深层次的内窥镜切除（ER）引起的设定，标准技术难以且与穿孔的风险相关。复位试验进一步评估了使用新型胃全厚度切除装置（GFTRD）胃设定夹子辅助内镜全厚度切除（EFTR）的可行性，疗效和安全性。材料和方法重置试验于2017年3月开始（NCT03096236），并设计为潜在观察多中心试验试验。包括高达15毫米的胃设定。主要终点是技术成功（完全enbloc切除术）。次要终点是R0切除，全厚切除，不良事件和复发性，在3个月后续行动。用于切除，我们使用GFTRD（杂志内镜，德国Tubingen）。结果29例患者接受了胃EFTR。常规活检后的组织学前EFTR仅在31.2％中限定组织学肿瘤类型。主要终点以89.7％达到。全厚度切除试样的组织学可在100％中定义组织学肿瘤型。可以切除76％的全部组织学完全（R0），并且可以在65.5％获得全厚度切除样品。在31％的人中轻微出血中观察并内窥镜地进行管理。随访79.3％（OTSC脱离78.3％，OTSC位于21.7％）。 3个月后没有观察到残留或复发性肿瘤的迹象。结论GFTRD胃设定EFTR是可行和安全的。与常规活组织检查相比，EFTR允许明确的组织学诊断（包括在GIST或网情况下的足够的风险分层）。在大多数情况下，R0-切除可能是可能的，并且可能会避免对选定患者进一步监测内窥镜的需求。

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