[A novel and simplified closure method for defect closure after endoscopic full-thickness resection of gastric submucosal tumors: short-term outcomes of "Shao-Mai" closure method].

Objective: To evaluate the feasibility and short-term efficacy of a novel and simplified closure method developed by our team for the defect closure after endoscopic full-thickness resection (EFTR) for gastric submucosal tumors (SMT) in the gastric wall. Methods: A prospective single-arm clinical study was used. Inclusion criteria: (1) the lesion was located in the fundus or the greater curvature of the stomach, and was confirmed to originate from the muscularis propria layer; (2) the diameter of the tumor was ≤3.5 cm, and the tumor had no extensive adhesion to the peritoneal tissues and organs in extraperitoneal cavity; (3) the tumor had no malignant features under ultrasound endoscopy; (4) the patient agreed to participate in the study; (5) patients with severe complications were excluded. Based on the above criteria, 20 patients with gastric SMT at the Endoscopy Center of Zhongshan Hospital of Fudan University from January 2015 to March 2018 were enrolled in this study, including 5 males and 15 females with mean age of 61.1 (38 to 70) years. Grasping forceps-assisted endo-loop snare ligation device which is called "Shao-Mai" method was used to close the defect site. All the patients underwent EFTR and "Shao-Mai" method to perform defect closure. After successful tumor resection by EFTR, an endo-loop was anchored onto the edge of the gastric defect with grasping forceps assistance and closed tightly. The observation indicators included tumor size, en bloc resection, operation time, postoperative complications and hospital stay. The follow-up indicators included tumor residual, local recurrence, and metachronous lesions. Results: All the 20 lesions were located in the muscularis propria with a size of 0.5-3.5 (mean 1.4) cm. Three of them were located in the greater curvature of the mid-upper gastric body, 17 were located in the fundus. The endoscopic "Shao-Mai" closure was successfully performed after EFTR in all the 20 cases. Endoscope was used uniquely through the entire process, without laparoscopic assistance. The operative time was 20-100 (mean 43.8) minutes, while the "Shao-Mai" closure procedure took a range of 3-30 (mean 10.1) minutes. The en bloc resection rate was 100%. The pathological diagnosis included 17 gastrointestinal stromal tumors and 3 leiomyomas. No major complications occurred during or after surgery. All the patients were discharged 1-11 (mean 3.1) days after operation. The wounds of all the cases were healed completely six months after operation and only scar was observed without ulcer. No residual lesion, tumor recurrence or metastasis, leakage or fistula of digestive tract were found during the follow-up period of 15-54 (median 41) months. Conclusion: The endoscopic "Shao-Mai" closure method is a simplified novel way, which is feasible, effective, and safe for closing the gastric defect after EFTR.目的： 评估本团队首创的"烧卖缝合法"在胃黏膜下肿瘤（SMT）内镜全层切除术（EFTR）后闭合缺损的可行性和近期疗效。 方法： 采用前瞻性单臂临床研究方法。纳入标准：（1）病灶位于胃底或胃大弯，并确认起源于固有肌层；（2）肿瘤直径≤3.5 cm，与腔外腹膜内组织和器官无广泛粘连；（3）肿瘤在超声内镜下无恶性肿瘤特征；（4）患者同意参与研究；排除严重合并疾病的患者。根据上述标准，2015年1月至2018年3月期间，复旦大学附属中山医院内镜中心收治的20例胃SMT患者入组本研究，其中男性5例，女性15例，平均年龄61.1（38~70）岁。全组均行EFTR并采用"烧卖缝合法"闭合术后胃壁缺损。"烧卖缝合法"使用临床上常见的内镜抓取钳辅助尼龙绳圈套结扎装置，借助抓取钳轻拉缺损胃壁，将尼龙绳圈套锚定在缺损部位并结扎，成功完成闭合。观察记录手术时间、闭合过程时间以及随访情况。 结果： 20例病例的肿瘤均通过EFTR一次性完整切除，全组胃壁缺损的部位均通过"烧卖缝合法"成功闭合。3例肿瘤位于胃大弯的中上部，17例肿瘤位于胃底部。肿瘤直径1.4（0.5~3.5）cm。平均手术时间为43.8（20~100）min，闭合过程平均耗时10.1（3~30）min。所有病例的病理结果均显示肿瘤完整切除，且肿瘤包膜无明显中断，整块切除率为100%。术中和术后均无严重并发症发生。患者平均于术后3.1（1~11）d出院。术后6个月时，所有病例的创面均已完全愈合，仅见瘢痕，未见溃疡。中位随访41（15~54）个月，未发现有残留病变、肿瘤复发或转移，亦未发现有消化道漏或窦道的形成。 结论： "烧卖缝合法"用于闭合胃SMT的EFTR后缺损的胃壁可行、有效、安全，是一种较为简单的新型闭合方法。.