Clinical advantages of robotic gastrectomy for clinical stage I/II gastric cancer: a multi-institutional prospective single-arm study
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Robotic gastrectomy (RG) for gastric cancer (GC) has been increasingly performed for a decade; however, evidence for its use as a standard treatment has not yet been established. The present study aimed to determine the safety, feasibility, and effectiveness of RG for GC.
This multi-institutional, single-arm prospective study, which included 330 patients from 15 institutions, was designed to compare morbidity rate of RG with that of a historical control (conventional laparoscopic gastrectomy, LG). This trial was approved for Advanced Medical Technology (“Senshiniryo”) B. The included patients were operable patients with cStage I/II GC. The primary endpoint was morbidity (Clavien–Dindo Grade ≥ IIIa). The specific hypothesis was that RG could reduce the morbidity rate to less than half of that with LG (6.4%). A sample size of 330 was considered sufficient (one-sided alpha 0.05, power 80%).
Among the 330 study patients, the protocol treatment was suspended in 4 patients. Thus, 326 patients fully enrolled and completed the study. The median patient age and BMI were 66 years and 22.4 kg/m2, respectively. Distal gastrectomy was performed in 253 (77.6%) patients. The median operative time and estimated blood loss were 313 min and 20 mL, respectively. No 30-day mortality was seen, and morbidity showed a significant reduction to 2.45% with RG (p = 0.0018).
RG for cStage I/II GC is safe and feasible. It may be effective in reducing morbidity with LG.
KeywordsStomach neoplasms Gastrectomy Robotic surgical procedure Minimally invasive surgical procedures Postoperative complications
Da Vinci surgical system
Postoperative pancreatic fistula
EuroQol 5 dimension
Contrast-enhanced computed tomography
Ministry of Health, Labour, and Welfare
Case report form
We thank all surgeons participating in this study especially to Yoshihiro Hiramatsu (Hamamatsu University, Hamamatsu, Japan), Takeshi Omori (Osaka International Cancer Institute, Osaka, Japan), Yuji Watanabe (Ehime University, Toon, Japan), Hironori Odaira (International University of Health and Welfare, Narita, Japan), Tomohisa Egawa (Saiseikai Yokohamashi Tobu Hospital, Yokohama, Japan), and Yoshiharu Sakai (Kyoto University, Kyoto, Japan). We also thank T. Kato, T. Koseki, and Y. Hiramatsu working in data collection center (Center for Research Promotion and Support, Fujita Health University). The authors are indebted to Maruzen Co., Ltd. (Tokyo, Japan) for their native English speaker’s review of this manuscript. All statistical analyses related to the study design and the endpoints were conducted by Sogo Rinsho Medefi Co., Ltd.
All the authors have fully met the ICMJE authorship criteria as follows: (1) study design—IU and KS; data collection—MN, MT, TK, HN, ST, KE, KO, SK, and HO; statistical analysis and interpretation of results—MN, KS, and IU. (2) Drafting of the manuscript—KS and MN; critical revision of the manuscript for important intellectual content—KS, IU, MN, MT, TK, HN, ST, KE, KO, SK, and HO. All authors read and approved the final manuscript. All authors are accountable for all the aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Compliance with ethical standards
Conflict of interest
In this study, Intuitive Surgical, Inc. reimbursed 500,000 JPY to each patient. Koichi Suda received a grant of Intuitive Surgical Operations, Inc. 2015 Clinical Robotic Research Grant for this study. The other authors have no conflicts of interest or financial ties to disclose.
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