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- Title
Early phase II study of robot-assisted distal gastrectomy with nodal dissection for clinical stage IA gastric cancer.
- Authors
Tokunaga, Masanori; Sugisawa, Norihiko; Kondo, Junya; Tanizawa, Yutaka; Bando, Etsuro; Kawamura, Taiichi; Terashima, Masanori
- Abstract
Background: Robot-assisted distal gastrectomy (RADG) is increasingly performed in Japan and Korea and is thought to have many advantages over laparoscopic gastrectomy. However, a prospective study investigating the safety of RADG has never been reported. The present study evaluated the safety of RADG with nodal dissection for clinical stage IA gastric cancer. Methods: This single-center, prospective phase II study included patients with clinical stage IA gastric cancer located within the lower two-thirds of the stomach. The primary endpoint was the incidence of postoperative intraabdominal infectious complications including anastomotic leakage, pancreas-related infection, and intraabdominal abscess. The secondary endpoints included all in-hospital adverse events, RADG completion rate, and survival outcome. Results: From May 2012 to November 2012, 18 eligible patients were enrolled for this study. The incidence of intraabdominal infectious complication was 0 % (90 % CI, 0-12.0 %). The overall incidence of in-hospital adverse events was 22.2 % (90 % CI, 8.0-43.9 %). No patient required conversion to laparoscopic or open gastrectomy; thus, the RADG completion rate was 100 %. Conclusions: This early phase II study suggested that RADG might be a safe and feasible procedure for stage IA gastric cancer, providing experienced surgeons perform the surgery. This conclusion should be clarified in subsequent late phase II studies with a larger sample size.
- Subjects
STOMACH cancer treatment; GASTRECTOMY; STOMACH surgery complications; LAPAROSCOPIC surgery; CLINICAL trials; SURGICAL robots
- Publication
Gastric Cancer, 2014, Vol 17, Issue 3, p542
- ISSN
1436-3291
- Publication type
Article
- DOI
10.1007/s10120-013-0293-3