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Title: [Surgical selection and metastatic warning of splenic lymph node dissection in advanced gastric cancer radical surgery: a prospective, single-center, randomized controlled trial].
Author: Guo X, Bian SB, Peng Z, Wang N, Wei B, Cui JX, Wang XX, Xie TY, Xi HQ, Chen L.
Journal: Zhonghua Wei Chang Wai Ke Za Zhi; 2020 Feb 25; 23(2):144-151. PubMed ID: 32074794.
Abstract:
Objective: To investigate the surgical options for splenic lymph node dissection in patients with advanced gastric cancer undergoing radical total gastrectomy, and to evaluate the sentinel effect of No. 4s lymph node on splenic lymph node metastasis. Methods: A prospective, single-center, randomized and controlled study was carried out (Trial registration, No.NCT02980861). Enrollment criteria: (1) >18 years old and <65 years old; (2) gastric adenocarcinoma locating in the proximal or corpus; (3) preoperative clinical staging as cT2-4aN0-3M0; (4) D2 radical total gastrectomy feasible judged before operation; (5) physical ability score 0 to 1; (6) I to III of ASA classification. Pregnant or lactating women, patients with severe mental illness or previous history of upper abdominal surgery, those suffered from other malignant tumors in the past 5 years, or heart and lung system diseases judged to affect surgery before operation, those receiving preoperative chemotherapy, radiotherapy or targeted therapies, and distant metastases being found during surgery were excluded. According to above criteria, 222 patients at The First Medical Center of Chinese PLA General Hospital from December 2016 to December 2017 were enrolled prospectively and were randomly divided into the laparoscopic splenic hilar lymph node dissection group (laparoscopic group, n=114) and the open splenic hilar lymph node dissection group (open group, n=108). The result of rapid frozen immunohistochemistry of harvested No.4s lymph nodes was used to evaluate the sensitivity and specificity of sentinel effect on splenic hilar lymph node metastasis. The surgical parameters, postoperative recovery parameters, and complication rates were compared between the two groups. Results: There were 80 males and 34 females in the lapascopic group with a mean age of (56.1±10.2) years, and 69 males and 39 females in the open group with a mean age of (58.4±10.9) years. There were no significant differences in baseline data between the two groups (all P>0.05). Total blood loss was less in the laparoscopic group [(96.3±82.4) ml vs. (116.6±101.9) ml, t=1.124, P<0.001], and the amount of bleeding from the splenic hilar lymph nodes dissected was also less than that in the open group [(25.3±17.8) ml vs. (59.5±36.4) ml, t=1.172, P<0.001]. However, the operation time, the time of splenic hilar lymph node, the number of lymph node dissected and number of splenic hilar lymph node dissected were not significantly different between the two groups (all P>0.05). As compared to the open group, the laparoscopic group had shorter time to the first flatus [(1.3±1.2) days vs. (1.6±1.5) days, t=1.665, P=0.021], shorter time to fluid diet [(4.6±1.4) days vs. (4.9 ± 1.6) days, t=1.436, P=0.007], shorter time to remove nasogastric tube [(3.9±2.6) days vs. (4.3±2.4) days, t=0.687, P<0.001] and shorter hospital stay [(10.3±6.6) days vs. (12.1±7.2) days, t=0.697, P<0.001]. Complication rate was 14.0% (16/114) and (12.0%) ((1)3/108) in the laparoscopic group and the open group, respectively, without significant difference (χ(2)=6.723, P=0.331). The sensitivity of the No. 4s lymph node for the prediction of splenic hilar lymph node metastasis reached 89.5%, and the specificity reached 99.6%. Conclusions: Laparoscopic technique is safe and feasible in the treatment of splenic hilar lymph node dissection in advanced gastric cancer. The No.4s lymph node examination has good sentinel effect on predicting the metastasis of splenic hilar lymph nodes. 目的： 探讨进展期胃癌患者行根治性全胃切除术时脾门淋巴结清扫的手术方式选择，并评价No.4s淋巴结对脾门淋巴结转移的预警效能。 方法： 本研究采用前瞻性、单中心、随机对照研究方法（Clinicaltrials.gov注册号NCT02980861）。纳入标准：（1）>18岁且<65岁；（2）肿瘤位于近端或胃体的胃腺癌；（3）术前临床分期为cT(2~4)aN(0~3)M(0)；（4）术前判断为可行D(2)根治手术；（5）体能评分0或1分；（6）美国麻醉医师协会分级为Ⅰ~Ⅲ级。排除怀孕或哺乳期女性、有严重精神疾病、既往上腹部手术史、近5年内曾患有其他恶性肿瘤疾病、术前判断为影响手术的心肺系统疾病及术前曾行化疗、放疗或其他靶向治疗者；剔除术中发现有远处转移者。根据上述标准，前瞻性纳入2016年12月至2017年12月期间，解放军总医院第一医学中心收治的222例近端和胃体胃癌患者，并根据随机数表随机分为腹腔镜脾门淋巴结清扫组（腹腔镜手术组，114例）和开腹脾门淋巴结清扫组（开腹手术组，108例），对比两组的手术指标、术后恢复指标和并发症发生情况，并评价No.4s淋巴结对脾门淋巴结转移的预警敏感性和特异性。 结果： 腹腔镜手术组中男性80例，女性34例，年龄为（56.1±10.2）岁；开腹手术组中男性69例，女性39例，年龄为（58.4±10.9）岁。两组基线资料差异无统计学意义（均P>0.05）。腹腔镜手术组的总失血量和清扫脾门淋巴结的出血量均少于开腹手术组[（96.3±82.4）ml比（116.6±101.9）ml，t=1.124，P<0.001；（25.3±17.8）ml比（59.5±36.4）ml，t=1.172，P<0.001]，而两组手术时间、脾门淋巴结清扫时间、淋巴结清扫数目和脾门淋巴结清扫数目相近（均P>0.05）。腹腔镜手术组患者的术后排气时间[（1.3±1.2）d比（1.6±1.5）d，t=1.665，P=0.021]、进流质饮食时间[（4.6±1.4）d比（4.9 ± 1.6）d，t=1.436，P=0.007]、胃管拔除时间[（3.9±2.6）d比（4.3±2.4）d，t=0.687，P<0.001]和住院时间[（10.3±6.6）d比（12.1±7.2）d，t=0.697，P<0.001]均短于开腹手术组患者。腹腔镜手术组和开腹手术组分别有16例（14.0%）和13例（12.0%）发生术后并发症，差异无统计学意义（χ(2)=6.723，P=0.331）。No.4s淋巴结对脾门淋巴结转移预测的敏感性达到89.5%，特异性达到99.6%。 结论： 腹腔镜技术在进展期胃癌全胃切除手术脾门淋巴结清扫中安全可行，No.4s淋巴结对于预测脾门淋巴结是否转移具有较好的示警效能。.

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