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A phase II trial of robotic distal gastrectomy for stage IA gastric cancer
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Kei Hosoda1,
Keishi Yamashita1,2,
Masahiko Watanabe1 |
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1Department of Surgery, School of Medicine, Kitasato University, 2Division of Advanced Surgical Oncology, Research and Development Center for New Medical Frontiers, School of Medicine, Kitasato University |
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| Background: Though the number of patients undergoing robotic distal gastrectomy (RDG) has been increasing, a prospective study to investigate the benefit of RDG has hardly been reported. We conducted a single-institutional phase II trial to evaluate the safety and feasibility of RDG with nodal dissection for patients with clinical stage IA gastric cancer. Methods: The subjects comprised patients with clinical stage IA gastric cancer with lower 2 thirds of the stomach. RDG with D1 plus dissection was aimed to be performed. The primary endpoint was the proportion of patients who developed intra-abdominal complications requiring treatment. The secondary endpoints included surgical morbidity and short-term clinical outcomes. Results: Between February 2015 and May 2018, 25 eligible patients were enrolled. No patient developed intra-abdominal complications requiring treatment (0%; 95% confidence interval, 0-0.14). Chylous ascites and Roux stasis with Clavien-Dindo grade I was observed in one and one patient, respectively. No patient developed in-hospital grade 3 or 4 adverse events. The short-term clinical outcomes were as follows: median operative time, 318 min; median console time, 274 min; median blood loss, 24 ml; median days of postoperative hospital stay, 7. Eight patients (32.0%) had a body temperature of 38 °C or higher during their hospital stay. Conclusions: This trial confirmed the safety of RDG performed by credentialed surgeons in terms of the incidence of intra-abdominal complications. A phase III trial to confirm the superiority of RDG to conventional laparoscopic distal gastrectomy is warranted. |
Index Term 1: Robotic gastrectomy
Index Term 2: Phase II trial |
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