研究动态
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早期胃癌保胃手术的生活质量和营养结果:SENORITA 随机临床试验的二次分析。

Quality of Life and Nutritional Outcomes of Stomach-Preserving Surgery for Early Gastric Cancer: A Secondary Analysis of the SENORITA Randomized Clinical Trial.

发表日期:2024 May 29
作者: Bang Wool Eom, Hong Man Yoon, Young-Woo Kim, Jae Seok Min, Ji Yeong An, Hoon Hur, Young Joon Lee, Gyu Seok Cho, Young Kyu Park, Mi Ran Jung, Ji Ho Park, Woo Jin Hyung, Sang Ho Jeong, Myeong-Cherl Kook, Mira Han, Byung-Ho Nam, Keun Won Ryu,
来源: JAMA Surgery

摘要:

面向前哨淋巴结的定制方法 (SENORITA) 随机临床试验评估了腹腔镜前哨淋巴结导航手术 (LSNNS) 和腹腔镜标准胃切除术 (LSG) 之间的生活质量 (QoL) 和营养结果。然而,目前尚无关于LSNNS组中接受保胃手术的患者的生活质量和营养结果的报道。 比较接受保胃手术和接受标准胃切除术的患者的长期生活质量和营养结果以确定与接受保胃手术的患者生活质量不佳相关的因素。本研究是 SENORITA 试验的二次分析,该试验是一项比较 LSNNS 与 LSG 的随机临床试验。 2013年3月至2016年12月期间,来自韩国7家三级或综合医院的患者被纳入研究,并进行了长达5年的随访。对2022年8月至9月期间的数据进行了分析。在试验参与者中,LSG组中接受了实际腹腔镜标准胃切除术的患者和LSNNS组中接受了保胃手术的患者均被纳入。未完成基线或任何随访调查问卷的患者被排除。保留胃手术与标准胃切除术。欧洲癌症研究和治疗组织 QoL 问卷核心 30 (EORTC QLQ-C30) 和胃模块 (STO22) 总体评分、体重指数、血红蛋白、蛋白质和白蛋白水平。本研究分别纳入了 194 例和 257 例接受胃保留手术和标准胃切除术的患者(平均 [SD] 年龄,55.6 [10.6] 岁; 249 [55.2%] 男性)。术后3个月,保胃组在身体功能(87.2 vs 83.9)、呼吸困难(5.9 vs 11.2)、食欲不振(13.1 vs 19.4)、吞咽困难(8.0 vs 12.7)、饮食限制(10.9)方面的生活质量得分更高与 18.2)、焦虑(29.0 vs 35.2)、味觉变化(7.4 vs 13.0)和身体形象(19.5 vs 27.2)。术后1年,保胃组的体重指数(23.9 vs 22.1,计算方法为体重公斤数除以身高米平方)、血红蛋白(14.3 vs 13.3 g/dL)、白蛋白(4.3 vs 4.25 g/dL)显着升高。 /dL)和蛋白质水平(7.3 vs 7.1 g/dL)与标准组相比。多变量分析表明,肿瘤位置(大曲率,下三分之一)与整体健康状况(β,10.5;95% CI,3.2 至 17.8)、反流(β,-8.4;95% CI,-14.7 至 -2.1)呈显着相关。 )和术后 3 个月保留胃组的饮食限制(β,-5.7;95% CI,-10.3 至 -1.0)。节段性切除与术后 3 年腹泻(β,40.6;95% CI,3.1 至 78.1)和饮食限制(β,15.1;95% CI,1.1 至 29.1)的风险相关。前哨淋巴结评估后进行保胃手术与标准胃切除术相比,与更好的长期生活质量和营养结果相关。这些发现可能有助于促进早期胃癌患者治疗的决策。ClinicalTrials.gov 标识符:NCT01804998。
The Sentinel Node Oriented Tailored Approach (SENORITA) randomized clinical trial evaluated quality of life (QoL) and nutritional outcomes between the laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG). However, there has been no report on the QoL and nutritional outcomes of patients who underwent stomach-preserving surgery among the LSNNS group.To compare long-term QoL and nutritional outcomes between patients who underwent stomach-preserving surgery and those who underwent standard gastrectomy and to identify factors associated with poor QoL outcomes in patients who underwent stomach-preserving surgery.This study is a secondary analysis of the SENORITA trial, a randomized clinical trial comparing LSNNS with LSG. Patients from 7 tertiary or general hospitals across the Republic of Korea were enrolled from March 2013 to December 2016, with follow-up through 5 years. Data were analyzed between August and September 2022. Among trial participants, patients who underwent actual laparoscopic standard gastrectomy in the LSG group and those who underwent stomach-preserving surgery in the LSNNS group were included. Patients who did not complete the baseline or any follow-up questionnaire were excluded.Stomach-preserving surgery vs standard gastrectomy.Overall European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30) and stomach module (STO22) scores, body mass index, hemoglobin, protein, and albumin levels.A total of 194 and 257 patients who underwent stomach-preserving surgery and standard gastrectomy, respectively, were included in this study (mean [SD] age, 55.6 [10.6] years; 249 [55.2%] male). The stomach-preserving group had better QoL scores at 3 months postoperatively in terms of physical function (87.2 vs 83.9), dyspnea (5.9 vs 11.2), appetite loss (13.1 vs 19.4), dysphagia (8.0 vs 12.7), eating restriction (10.9 vs 18.2), anxiety (29.0 vs 35.2), taste change (7.4 vs 13.0), and body image (19.5 vs 27.2). At 1 year postoperatively, the stomach-preserving group had significantly higher body mass index (23.9 vs 22.1, calculated as weight in kilograms divided by height in meters squared) and hemoglobin (14.3 vs 13.3 g/dL), albumin (4.3 vs 4.25 g/dL), and protein (7.3 vs 7.1 g/dL) levels compared to the standard group. Multivariable analyses showed that tumor location (greater curvature, lower third) was favorably associated with global health status (β, 10.5; 95% CI, 3.2 to 17.8), reflux (β, -8.4; 95% CI, -14.7 to -2.1), and eating restriction (β, -5.7; 95% CI, -10.3 to -1.0) at 3 months postoperatively in the stomach-preserving group. Segmental resection was associated with risk of diarrhea (β, 40.6; 95% CI, 3.1 to 78.1) and eating restriction (β, 15.1; 95% CI, 1.1 to 29.1) at 3 years postoperatively.Stomach-preserving surgery after sentinel node evaluation was associated with better long-term QoL and nutritional outcomes than standard gastrectomy. These findings may help facilitate decision-making regarding treatment for patients with early-stage gastric cancer.ClinicalTrials.gov Identifier: NCT01804998.