内镜黏膜下剥离术后行全腹腔镜远端胃切除术和直接行全腹腔镜远端胃切除术治疗早期胃癌的近期疗效

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目的:探讨内镜黏膜下剥离术(ESD)后行全腹腔镜远端胃切除术(TLDG)和直接行TLDG治疗早期胃癌的近期疗效。方法:采用倾向评分匹配及回顾性队列研究方法。收集2014年3月至2019年12月南京医科大学第一附属医院收治的623例早期胃癌病人的临床病理资料;男405例,女218例;中位年龄为62岁,年龄范围为26~86岁。623例病人中,25例为ESD后行TLDG,设为ESD+TLDG组;598例为直接行TLDG,设为TLDG组。观察指标:(1)倾向评分匹配情况及匹配后两组病人一般资料比较。(2)TLDG术中和术后情况。(3)ESD+TLDG组病人分层分析。倾向评分匹配按1∶2最近邻匹配法匹配。正态分布的计量资料以n x±s表示,组间比较采用n t检验。偏态分布的计量资料以n M(范围)表示,组间比较采用Mann-Whitney n U检验。计数资料以绝对数表示,组间比较采用n χ2检验或Fisher确切概率法。等级资料组间比较采用Mann-Whitney n U检验。n 结果:(1)倾向评分匹配情况及匹配后两组病人一般资料比较:623例病人中,75例配对成功,其中ESD+TLDG组25例,TLDG组50例。ESD+TLDG组病人倾向评分匹配前体质量指数(BMI),肿瘤长径(≤20 mm、21~30 mm、>30 mm),临床分期(Ⅰ期、Ⅱ期、Ⅲ期)分别为(22.3±3.6)kg/mn 2,16、6、3例,24、1、0例,TLDG组病人上述指标分别为(24.3±2.7)kg/mn 2,238、125、235例,312、126、160例,两组病人上述指标比较,差异均有统计学意义(n t=2.744,n Z=-2.834、-4.209,n P30 mm),临床分期(Ⅰ期、Ⅱ期)分别为(22.3±3.6)kg/mn 2,16、6、3例,24、1例和(23.6±2.9)kg/mn 2,29、12、9例,48、2例,两组病人上述指标比较,差异均无统计学意义(n t=1.542,Z=-0.597、0.000,n P>0.05)。(2)TLDG术中和术后情况:倾向评分匹配后两组病人TLDG手术时间、术后引流管拔除时间分别为180 min(124~289 min)、6 d(4~13 d)和170 min(106~250 min)、6 d(4~9 d),两组病人上述指标比较,差异均有统计学意义(n Z=-2.396,-3.039,n P0.05)。发生吻合口出血病人经内镜下止血后缓解,其余并发症病人经保守治疗后均缓解。(3)ESD+TLDG组病人分层分析:①5例ESD后≤14 d行TLDG病人与20例ESD后>14 d行TLDG病人,TLDG手术时间,术中出血量(100 mL),淋巴结清扫数目,术后引流管拔除时间,术后住院时间,围术期并发症分别为200 min(170~289 min),0、3、2例,36枚(9~57枚),7 d(5~9 d),8 d (7~9 d),1例和180 min(124~253 min),8、6、6例,34枚(8~78枚),6 d(4~13 d),8 d(6~31 d),1例,TLDG手术时间、术中出血量、淋巴结清扫数目、术后引流管拔除时间、术后住院时间比较,差异均无统计学意义(n Z=-1.536,-1.993,-0.238,-0.932,-0.589,n P>0.05),围术期并发症比较,差异无统计学意义(n P>0.05)。②13例ESD后≤21 d行TLDG病人与12例ESD后>21 d行TLDG病人,TLDG手术时间,术中出血量(100 mL),淋巴结清扫数目,术后引流管拔除时间,术后住院时间,围术期并发症分别为200 min(145~289 min),2、6、5例,34 枚(8~57枚),6 d(4~11 d),8 d(6~11 d),1例和179 min(124~240 min),6、3、3例,34 枚(16~78枚),6 d(5~13 d),8 d (6~31 d),1例;TLDG手术时间比较,差异有统计学意义(Z=-2.241,n P0.05),围术期并发症比较,差异无统计学意义(n P>0.05)。③15例ESD后≤28 d行TLDG病人与10例ESD后>28 d行TLDG病人,TLDG手术时间,术中出血量(100 mL),淋巴结清扫数目,术后引流管拔除时间,术后住院时间,围术期并发症分别为190 min (145~289 min),2、7、6例,33枚(8~57枚),6 d(4~11 d),8 d(6~31 d),1例和179 min(124~240 min),6、2、2例,37枚(16~78枚),6 d(5~13 d),8 d (6~14 d),1例,TLDG手术时间、术中出血量、淋巴结清扫数目、术后引流管拔除时间、术后住院时间比较,差异均无统计学意义(n Z=-1.619,-2.000,-0.667,-0.370,-0.057,n P>0.05),围术期并发症比较,差异无统计学意义(n P>0.05)。n 结论:与直接行TLDG比较,早期胃癌行ESD+TLDG会延长TLDG手术时间和术后引流管拔除时间,但不影响近期疗效;早期胃癌ESD后≤21 d行TLDG与>21 d行TLDG手术时间比较,差异有统计学意义。“,”Objective:To investigate the short-term efficacy of totally laparoscopic distal gastrectomy (TLDG) after endoscopic submucosal dissection (ESD) versus direct TLDG for early gastric cancer.Methods:The propensity score matching and retrospective cohort study was conducted. The clinicopathological data of 623 patients with early gastric cancer who were admitted to the First Affiliated Hospital of Nanjing Medical University from March 2014 to December 2019 were collected. There were 405 males and 218 females, aged from 26 to 86 years, with a median age of 62 years. Of 623 patients, 25 cases undergoing TLDG after ESD were divided into ESD+TLDG group and 598 cases undergoing TLDG directly were divided into TLDG group. Observation indicators: (1) the propensity score matching conditions and comparison of general data between the two groups after propensity score matching; (2) intraoperative and postoperative situations of TLDG; (3) stratification analysis of the ESD+TLDG group. The propensity score matching was conducted by 1∶2 matching using the nearest neighbor method. Measurement data with normal distribution were represented as n Mean±SD, and comparison between groups was done using the n t test. Measurement data with skewed distribution were represented as n M (range) and comparison between groups was done using the Mann-Whitney n U test. Count data were represented as absolute numbers, and comparison between groups was analyzed using the chi-square test or Fisher exact probability. Comparison of ordinal data between groups was analyzed using the Mann-Whitney n U test.n Results:(1) The propensity score matching conditions and comparison of general data between the two groups after propensity score matching: 75 of 623 patients had successful matching, including 25 in the ESD+TLDG group and 50 in the TLDG group. Before propensity score matching, the body mass index (BMI), cases with tumor diameter ≤20 mm, 21 to 30 mm or>30 mm, cases with tumor classified as stage Ⅰ, stage Ⅱ or stage Ⅲ of clinical staging were (22.3±3.6)kg/mn 2, 16, 6, 3, 24, 1, 0 of the ESD+TLDG group, respectively, versus (24.3±2.7)kg/mn 2, 238, 125, 235, 312, 126, 160 of the TLDG group, showing significant differences in the above indicators between the two groups (n t=2.744, n Z=?2.834, ?4.209, n P30 mm, cases with tumor classified as stage Ⅰ or stage Ⅱ of clinical staging were (22.3±3.6)kg/mn 2, 16, 6, 3, 24, 1 of the ESD+TLDG group, versus (23.6±2.9)kg/mn 2, 29, 12, 9, 48, 2 of the TLDG group, showing no significant difference between the two groups (n t=1.542, n Z=?0.597, 0.000, n P>0.05). (2) Intraoperative and postoperative situations of TLDG: after propensity score matching, the operation time and time to postoperative drainage tube removal were 180 minutes(range, 124 to 289 minutes) and 6 days(range, 4 to 13 days) of the ESD+TLDG group,respectively,versus 170 minutes(range, 106 to 250 minutes) and 6 days (range, 4 to 9 days) of the TLDG group, showing significant differences between the two groups (n Z=-2.396, -3.039, n P0.05). Cases with anastomotic bleeding were recovered after hemostasis under endoscopy and cases with other perioperative complications were recovered after conservative treatment. (3) Stratification analysis of the ESD+TLDG group. ① For 5 cases undergoing TLDG ≤14 days after ESD and 20 cases undergoing TLDG >14 days after ESD, the operation time of TLDG, cases with the volume of intraoperative blood loss 100 mL during TLDG, the number of lymph node dissected, time to postoperative drainage tube removal, duration of postoperative hospital stay, cases with perioperative complications were 200 minutes(range, 170 to 289 minutes), 0, 3, 2, 36(range, 9 to 57), 7 days(range, 5 to 9 days), 8 days(range, 7 to 9 days), 1 and 180 minutes (range, 124 to 253 minutes), 8, 6, 6, 34(range, 8 to 78), 6 days(range, 4 to 13 days), 8 days(range, 6 to 31 days), 1, respectively, showing no significant difference in the operation time of TLDG, volume of intraoperative blood loss during TLDG, the number of lymph node dissected, time to postoperative tube removal and duration of postoperative hospital stay between the two groups (n Z=?1.536, ?1.993, ?0.238, ?0.932, ?0.589, n P>0.05), and no significant difference in cases with perioperative complications between the two groups (n P>0.05). ② For 13 cases undergoing TLDG ≤21 days after ESD and cases undergoing TLDG >21 days after ESD, the operation time of TLDG, cases with the volume of intraoperative blood loss as 100 mL during TLDG, the number of lymph node dissected, time to postoperative drainage tube removal, duration of postoperative hospital stay, cases with perioperative complications were 200 minutes(range, 145 to 289 minutes), 2, 6, 5, 34(range, 8 to 57), 6 days(range, 4 to 11 days), 8 days(range, 6 to 11 days), 1 and 179 minutes(range, 124 to 240 minutes), 6, 3, 3, 34(range, 16 to 78), 6 days(range, 5 to 13 days), 8 days(range, 6 to 31 days), 1, respectively, showing a significant difference in the operation time of TLDG between the two groups (n Z=?2.241, n P0.05) and no significant difference in cases with perioperative complications between the two groups (n P>0.05). ③ For 15 cases undergoing TLDG ≤28 days after ESD and 10 cases undergoing TLDG >28 days after ESD, the operation time of TLDG, cases with the volume of intraoperative blood loss 100 mL during TLDG, the number of lymph node dissected, time to postoperative drainage tube removal, duration of postoperative hospital stay, cases with perioperative complications were 190 minutes (range, 145 to 289 minutes), 2, 7, 6, 33(range, 8 to 57), 6 days(range, 4 to 11 days), 8 days(range, 6 to 31 days), 1 and 179 minutes(range, 124 to 240 minutes), 6, 2, 2, 37(range, 16 to 78), 6 days (range, 5 to 13 days), 8 days(range, 6 to 14 days), 1, respectively, showing no significant difference in the operation time of TLDG, volume of intraoperative blood loss during TLDG, the number of lymph node dissected, time to postoperative tube removal and duration of postoperative hospital stay between the two groups (n Z=?1.619, ?2.000, ?0.667, ?0.370, ?0.057, n P>0.05), and no significant difference in cases with perioperative complications between the two groups (n P>0.05).n Conclusions:Compared with cases undergoing TLDG directly, the operation time to TLDG and time to drainage tube removal after TLDG for cases undergoing ESD+TLDG are prolonged, but there is no difference in the short-term efficacy. For cases undergoing TLDG ≤21 days after ESD and cases undergoing TLDG >21 days after ESD, there is a significant difference in the operation time of TLDG.
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