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)

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发表日期：

2024年11月5日

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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

摘要

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.