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Long-term oncological outcomes of 3D versus 2D laparoscopic gastrectomy for gastric cancer: a randomized clinical trial

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Abstract

Background

Laparoscopy-assisted gastrectomy (LG) is rapidly gaining popularity owing to its minimal invasiveness. Previous studies have found that compared with two-dimensional (2D)-LG, three-dimensional (3D)-LG showed better short-term outcomes. However, the long-term oncological outcomes in patients with locally resectable gastric cancer (GC) remain controversial.

Methods

In this noninferiority, open-label, randomized clinical trial, a total of 438 eligible GC participants were randomly assigned in a 1:1 ratio to either 3D-LG or 2D-LG from January 2015 to April 2016. The primary endpoint was operating time, while the secondary endpoints included 5-year overall survival (OS), disease-free survival (DFS), and recurrence pattern.

Results

Data from 401 participants were included in the per-protocol analysis, with 204 patients in the 3D group and 197 patients in the 2D group. The 5-year OS and DFS rates were comparable between the 3D and 2D groups (5-year OS: 70.6% vs. 71.1%, Log-rank P = 0.743; 5-year DFS: 68.1% vs. 69.0%, log-rank P = 0.712). No significant differences were observed between the 3D and 2D groups in the 5-year recurrence rate (28.9% vs. 28.9%, P = 0.958) or recurrence time (mean time, 22.6 vs. 20.5 months, P = 0.412). Further stratified analysis based on the type of gastrectomy, postoperative pathological staging, and preoperative BMI showed that the 5-year OS, DFS, and recurrence rates of the 3D group in each subgroup were similar to those of the 2D group (all P > 0.05).

Conclusions

For patients with locally resectable GC, 3D-LG performed by experienced surgeons in high-volume professional institutions can achieve long-term oncological outcomes comparable to those of 2D-LG.

Registration number

NCT02327481 (http://clinicaltrials.gov).

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Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We thank those who have devoted a lot to this study, including nurses, pathologists, further-study surgeons, statisticians, reviewers and editors. Thanks for Dr. Zhi-Hong Huang, Public Technology Service Center, Fujian Medical University. We would like to thank Editage (www.editage.cn) for English language editing. They were not financially compensated for their contributions.

Funding

This study was supported by Province Medical “Creating high-level hospitals, high-level medical centers and key specialty projects” [MWYZ (2021) No. 76], Talent Initiation Fund Project of Fujian Medical University Union Hospital (2022XH041), Yunnan Provincial Science and Technology Department (202105AF150040).

Author information

Author notes

  1. Qing Zhong, Jun-Yu Chen, Zhi-Xin Shang-Guan and Zhi-Yu Liu have contributed equally to this work and should be considered co-first authors.

Authors and Affiliations

  1. Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian Province, China

    Qing Zhong, Jun-Yu Chen, Zhi-Xin Shang-Guan, Zhi-Yu Liu, Guang-Tan Lin, Dong Wu, Yi-Ming Jiang, Jia-Bin Wang, Jian-Xian Lin, Qi-Yue Chen, Ju-Li Lin, Jian-Wei Xie, Ping Li, Jun Lu, Chang-Ming Huang & Chao-Hui Zheng

  2. Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China

    Qing Zhong, Jun-Yu Chen, Zhi-Xin Shang-Guan, Zhi-Yu Liu, Guang-Tan Lin, Dong Wu, Yi-Ming Jiang, Jia-Bin Wang, Jian-Xian Lin, Qi-Yue Chen, Ju-Li Lin, Jian-Wei Xie, Ping Li, Jun Lu, Chang-Ming Huang & Chao-Hui Zheng

  3. Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China

    Qing Zhong, Jun-Yu Chen, Zhi-Xin Shang-Guan, Zhi-Yu Liu, Guang-Tan Lin, Dong Wu, Yi-Ming Jiang, Jia-Bin Wang, Jian-Xian Lin, Qi-Yue Chen, Ju-Li Lin, Jian-Wei Xie, Ping Li, Jun Lu, Chang-Ming Huang & Chao-Hui Zheng

  4. Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China

    Qing Zhong, Jun-Yu Chen, Zhi-Xin Shang-Guan, Zhi-Yu Liu, Guang-Tan Lin, Dong Wu, Yi-Ming Jiang, Jia-Bin Wang, Jian-Xian Lin, Qi-Yue Chen, Ju-Li Lin, Jian-Wei Xie, Ping Li, Jun Lu, Chang-Ming Huang & Chao-Hui Zheng

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  1. Qing Zhong
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Contributions

Concept and design: ZQ, CJY, SGZX, HCM, and ZCH. Acquisition, analysis, or interpretation of data: CJY, SGZX, LGT, and LZY. Drafting of the manuscript: ZQ, CJY, SGZX, LJ, HCM, and ZCH. Statistical analysis: ZQ, CJY, SGZX, and LJ. Administrative, technical, or material support: LZY, LGT, WD, JYM, WJB, LJX, CQY, LJL, XJW, and LP. Supervision: ZQ, CJY, and SGZX.

Corresponding author

Correspondence to Chao-Hui Zheng.

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This study was conducted with the approval of the Biomedical ethical review committee of Fujian Medical University of China (IRB:2014019).

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All authors have no conflict of interest and no potential benefits. The institutional review boards of all the participating institutions approved the study. The authors have no other disclosures to report.

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Supplementary file 1

. Supplemental Digital Content 1. FUGES-001 Study Protocol ver.1.1. (DOCX 15272 kb)

Supplementary file 2

. Supplemental Digital Content 2. eTables and eFigures. eTable 1. Eligibility Criteria for Enrolling Patients. eTable 2. Univariable and Multivariable Cox Regression Analyses of Risk Factors for PRS. eTable 3. Frequencies of Causes of First Recurrence Within 5 Years After Surgery between 3D and 2D Groups in patients with total gastrectomy. eTable 4. Frequencies of Causes of First Recurrence Within 5 Years After Surgery between 3D and 2D Groups in patients with distal gastrectomy. eTable 5. Frequencies of Causes of First Recurrence Within 5 Years After Surgery. between 3D and 2D Groups in patients of pI staging. eTable 6. Frequencies of Causes of First Recurrence Within 5 Years After Surgery between 3D and 2D Groups in patients of pII staging. eTable 7. Frequencies of Causes of First Recurrence Within 5 Years After Surgery between 3D and 2D Groups in patients of pIII staging. eTable 8. Frequencies of Causes of First Recurrence Within 5 Years After Surgery between 3D and 2D Groups in patients of BMI ≤ 25. eTable 9. Frequencies of Causes of First Recurrence Within 5 Years After Surgery between 3D and 2D Groups in patients of BMI > 25. eFig. 1: Cumulative Incidence of Any Recurrence for 3D versus 2D Group within 5 Years after Surgery. eFig. 2: Recurrent site columnar distribution map. eFig. 3: Postoperative recurrence time nuclear density map. eFig. 4: Post-recurrence survival for 3D-Laparoscopic Gastrectomy versus 2D-Laparoscopic Gastrectomy at 5 Years After Surgery. eFig. 5. Kaplan–Meier Curves Comparing Overall Survival (A) and Disease-free Survival (B) Between the 3D Group and 2D Group in patients with total gastrectomy. eFig. 6. Kaplan–Meier Curves Comparing Overall Survival (A) and Disease-free Survival (B) Between the 3D Group and 2D Group in patients with distal gastrectomy. eFig. 7. Kaplan–Meier Curves Comparing Overall Survival (A) and Disease-free Survival (B) Between the 3D Group and 2D Group in patients of pI staging. eFig. 8. Kaplan–Meier Curves Comparing Overall Survival (A) and Disease-free Survival (B) Between the 3D Group and 2D Group in patients of pII staging. eFig. 9. Kaplan–Meier Curves Comparing Overall Survival (A) and Disease-free Survival (B) Between the 3D Group and 2D Group in patients of pIII staging. eFig. 10. Kaplan–Meier Curves Comparing Overall Survival (A) and Disease-free Survival (B) Between the 3D Group and 2D Group in patients of BMI ≤ 25. eFig. 11. Kaplan–Meier Curves Comparing Overall Survival (A) and Disease-free Survival (B) Between the 3D Group and 2D Group in patients of BMI > 25. (DOCX 1271 kb)

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Zhong, Q., Chen, JY., Shang-Guan, ZX. et al. Long-term oncological outcomes of 3D versus 2D laparoscopic gastrectomy for gastric cancer: a randomized clinical trial. Gastric Cancer 27, 598–610 (2024). https://doi.org/10.1007/s10120-024-01470-0

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