Morbidity and quality of life of totally laparoscopic versus laparoscopy-assisted distal gastrectomy for early gastric cancer: a multi-center prospective randomized controlled trial (CKLASS01).

IF 6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Gastric Cancer Pub Date : 2024-11-05 DOI:10.1007/s10120-024-01561-y
Yu Zhang, Ziyu Li, Yantao Tian, Jiang Yu, Jieti Wang, Changmin Lee, Kuan Wang, Xianli He, Qing Qiao, Gang Ji, Zekuan Xu, Li Yang, Hao Xu, Xiaohui Du, Xiangqian Su, Jiadi Xing, Zhaojian Niu, Linghua Zhu, Su Yan, Yong Li, Junjiang Wang, Zhengrong Li, Yongliang Zhao, Jun You, Changqing Jing, Lin Fan, Yian Du, Gaoping Zhao, Wu Song, Yi Xuan, Mingde Zang, Jie Chen, Sungsoo Park, Hua Huang
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Abstract

Background: There is a paucity of confirmatory randomized controlled trials (RCTs) comparing the effectiveness of totally laparoscopic distal gastrectomy (TLDG) vs laparoscopy-assisted distal gastrectomy (LADG) for early gastric cancer (EGC).

Methods: A phase III, prospective, multi-center RCT was conducted, wherein patients (n = 442) with clinical stage I gastric cancer eligible for laparoscopic distal gastrectomy were randomized 1:1 to the TLDG or the LADG group. Postoperative morbidity and quality of life (QoL) were compared.

Results: In total, 422 patients were assessed (TLDG, 216; LADG, 206) in the modified intention-to-treat (mITT) analysis. The morbidity rate did not differ significantly between the two groups (TLDG, 6.0%; LADG, 5.8%; P = 0.93). The 90-day mortality rate was comparable between the groups (TLDG, 0.5%; LADG, 0.0%; P > 0.99). TLDG was significantly associated with a lower pain score compared with LADG in patients with a BMI of ≥ 25 kg/m2 (P = 0.002) at 24 h postoperatively. Moreover, TLDG significantly improved QoL in terms of C30 social functioning at 3 and 6 months (P = 0.03 and P = 0.04), C30 global health status at 3 months (P = 0.02), and STO22 body image at 3 months (P = 0.01), with differences dissipating at 12 months.

Conclusions: TLDG is not superior to LADG in terms of postoperative morbidity and mortality, but it provides better C30 social functioning at 3 and 6 months, C30 global health status and STO22 body image at 3 months, and reduces early postoperative pain for patients with a BMI of ≥ 25 kg/m2.

Trial registration: ClinicalTrials.gov: NCT03393182.

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早期胃癌全腹腔镜与腹腔镜辅助远端胃切除术的发病率和生活质量:一项多中心前瞻性随机对照试验(CKLASS01)。
背景:比较全腹腔镜远端胃切除术(TLDG)与腹腔镜辅助远端胃切除术(LADG)治疗早期胃癌(EGC)疗效的确证性随机对照试验(RCT)很少:进行了一项III期、前瞻性、多中心RCT研究,将符合腹腔镜远端胃切除术条件的临床I期胃癌患者(n = 442)按1:1随机分配到TLDG组或LADG组。比较了术后发病率和生活质量(QoL):在改良意向治疗(mITT)分析中,共评估了422名患者(TLDG,216人;LADG,206人)。两组患者的发病率无明显差异(TLDG,6.0%;LADG,5.8%;P = 0.93)。两组的 90 天死亡率相当(TLDG,0.5%;LADG,0.0%;P > 0.99)。与 LADG 相比,TLDG 能明显降低体重指数≥ 25 kg/m2 患者术后 24 小时的疼痛评分(P = 0.002)。此外,TLDG在3个月和6个月时明显改善了C30社会功能的QoL(P = 0.03和P = 0.04),3个月时改善了C30总体健康状况(P = 0.02),3个月时改善了STO22身体形象(P = 0.01),12个月时差异消失:结论:就术后发病率和死亡率而言,TLDG并不优于LADG,但它在3个月和6个月时的C30社会功能、3个月时的C30总体健康状况和STO22身体形象均优于LADG,并能减轻体重指数≥25 kg/m2患者的术后早期疼痛:试验注册:ClinicalTrials.gov:试验注册:ClinicalTrials.gov:NCT03393182。
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来源期刊
Gastric Cancer
Gastric Cancer 医学-胃肠肝病学
CiteScore
14.70
自引率
2.70%
发文量
80
审稿时长
6-12 weeks
期刊介绍: Gastric Cancer is an esteemed global forum that focuses on various aspects of gastric cancer research, treatment, and biology worldwide. The journal promotes a diverse range of content, including original articles, case reports, short communications, and technical notes. It also welcomes Letters to the Editor discussing published articles or sharing viewpoints on gastric cancer topics. Review articles are predominantly sought after by the Editor, ensuring comprehensive coverage of the field. With a dedicated and knowledgeable editorial team, the journal is committed to providing exceptional support and ensuring high levels of author satisfaction. In fact, over 90% of published authors have expressed their intent to publish again in our esteemed journal.
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