内镜黏膜下肿瘤挖除术不行黏膜下注射治疗小型胃固有肌层肿瘤的疗效和安全性

Clinical efficacy and safety of non‑submucosal injection in endoscopic submucosal excavation for small gastric muscularis propria tumors

摘要:

目的 探讨内镜黏膜下肿瘤挖除术（endoscopic submucosal excavation，ESE）不行黏膜下注射治疗源自胃固有肌层的小型黏膜下肿瘤的疗效和安全性。方法 2018年11月—2020年10月，在浙江省中医院消化内镜中心诊断为小型胃固有肌层肿瘤（肿瘤直径≤2 cm）的患者纳入随机对照研究，采用计算机随机分组方法分为观察组（行未行黏膜下注射的ESE治疗）和对照组（行传统ESE治疗），比较2组的瘤体暴露时间、瘤体挖除时间、手术费用、住院周期、金属夹使用数量和并发症发生情况。结果 共有138例患者入组，其中观察组76例、对照组62例，所有病灶被顺利完整切除。与对照组比较，观察组的中位瘤体暴露时间更短［2.00 min比3.30 min，Z=-2.426，P=0.045］、中位瘤体挖除时间更短［16.8 min比34.4 min，Z=-4.324，P<0.001］、中位手术费用更少［2 903元比3 178元，Z=-5.112，P<0.001］、金属夹使用数量更少［（4.0±0.6）个比（5.1±1.3）个，t=1.452，P=0.003］、术后腹胀发生率更低［9.2%（7/76）比22.6%（14/62），χ2=2.512，P=0.049］、术后腹痛发生率更低［11.8%（9/76）比32.3%（20/62），χ2=4.242，P=0.014］，而在住院周期以及术后发热、穿孔发生率方面差异均无统计学意义（P>0.05）。结论 对于源自胃固有肌层的黏膜下肿瘤，瘤体直径在2.0 cm范围内时，行未行黏膜下注射的ESE治疗安全、有效，且较传统的ESE更具优势。

Abstract:

Objective To evaluate the efficacy and safety of non-submucosal injection in endoscopic submucosal excavation (ESE) for small submucosal tumors originating in the muscularis propria of the stomach. Methods A total of 138 patients diagnosed as having small gastric muscularis propria tumors (≤2 cm) at Digestive Endoscopy Center of Zhejiang Provincial Hospital of Chinese Medical from November 2018 to October 2020 were randomly divided into the observation group with non-submucosal injection of ESE and the control group with submucosal injection of ESE for a randomized controlled trial. The exposure time, tumor removal time, operation cost, hospitalization period, numbers of metal clips and complications of the two groups were analyzed and compared. Results A total of 138 patients were enrolled, including 76 patients in the observation group and 62 patients in the control group. All lesions were successfully and completely removed. Compared with the control group, the observation group had shorter median tumor exposure time [2.00 min VS 3.30 min, Z=-2.426, P =0.045], shorter median tumor removal time [16.8 min VS 34.4 min, Z=-4.324, P<0.001], less median surgical cost [2 903 yuan VS 3 178 yuan, Z=-5.112, P<0.001], and fewer metal clips used (4.0±0.6 VS 5.1±1.3, t=1.452, P=0.003). The incidence of postoperative abdominal distension of the observation group was lower [9.2% (7/76) VS 22.6% (14/62), χ2=2.512, P=0.049], the incidence of postoperative abdominal pain of this group was lower too [11.8% (9/76) VS 32.3% (20/62), χ2=4.242, P=0.014], but there was no significant difference in the period of hospitalization, incidence of postoperative fever or perforation (P>0.05). Conclusion Non-submucosal injection of ESE is safe and effective for submucosal tumors smaller than 2.0 cm originating from the muscularis propria of the stomach , which might be more advantageous than traditional ESE.