Late phase II study of robot-assisted gastrectomy with nodal dissection for clinical stage I gastric cancer.
The feasibility of robot-assisted gastrectomy (RG) in terms of safety is unclear due to a lack of prospective studies. We showed feasible surgical outcomes in our previous study. In this phase II study, we assessed feasibility of the procedure by recruiting a larger number of patients.



This single-center, prospective phase II study included patients with clinical stage I gastric cancer undergoing RG. The primary end point was the incidence of postoperative intra-abdominal infectious complications, including anastomotic leakage, pancreas-related infection, and intra-abdominal abscess. The secondary end points were overall survival, relapse-free survival, RG completion rate, and incidence of all surgical morbidities.



A total of 120 patients were recruited between December 2012 and April 2015. The incidence of intra-abdominal infectious complications was 3.3 % (95 % CI 0.9-8.3 %), and all complications were successfully treated conservatively without re-operation. The incidence of overall adverse events was 14.2 % (95 % CI 8.5-21.7 %). Three patients required conversion to open gastrectomy according to the protocol due to advancement of disease.



Our data show that RG is safe in terms of the incidence and severity of postoperative complications.
Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan. m.tokunaga@scchr.jp.
Masanori
M
Tokunaga
Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Rie
R
Makuuchi
Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Yuiciro
Y
Miki
Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Yutaka
Y
Tanizawa
Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Etsuro
E
Bando
Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Taiichi
T
Kawamura
Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Masanori
M
Terashima
D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061887:Conversion to Open Surgery / Q000706:statistics & numerical data; D005260:Female; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D008197:Lymph Node Excision; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D065287:Robotic Surgical Procedures; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D055815:Young Adult
Clinical trial; Gastrectomy; Gastric cancer; Robot; da Vinci