Journal Article

Clinical advantages of robotic gastrectomy for clinical stage I/II gastric cancer: a multi-institutional prospective single-arm study

Kinoshita, Takahiro, Okabe, Hiroshi, Suda, Koichi, Kuwabara, Shiro, Nakauchi, Masaya, Noshiro, Hirokazu, Ehara, Kazuhisa, Uyama, Ichiro, Terashima, Masanori, Takiguchi, Shuji, Obama, Kazutaka

2019

Overview

BackgroundRobotic 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.MethodsThis 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%).ResultsAmong 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).ConclusionsRG for cStage I/II GC is safe and feasible. It may be effective in reducing morbidity with LG.

• Publisher: Springer Nature B.V
• Subject: Gastrectomy / Gastric cancer / Laparoscopy / Morbidity / Oncology / Patients