Ichiro Uyama1, Koichi Suda2, Masaya Nakauchi2, Takahiro Kinoshita3, Hirokazu Noshiro4, Shuji Takiguchi5,6, Kazuhisa Ehara7, Kazutaka Obama8,9, Shiro Kuwabara10, Hiroshi Okabe11, Masanori Terashima12. 1. Department of Surgery, Fujita Health University, 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192, Japan. iuyama@mac.com. 2. Department of Surgery, Fujita Health University, 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192, Japan. 3. Gastric Surgery Division, National Cancer Center Hospital East, Kashiwa, Japan. 4. Department of Surgery, Saga University Faculty of Medicine, Saga, Japan. 5. Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan. 6. Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan. 7. Department of Gastroenterological Surgery, Saitama Cancer Center, Saitama, Japan. 8. Department of Surgery, Kyoto City Hospital, Kyoto, Japan. 9. Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 10. Digestive Surgery, Niigata City General Hospital, Niigata, Japan. 11. Department of Surgery, Otsu City Hospital, Otsu, Japan. 12. Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.
Abstract
BACKGROUND: 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. METHODS: 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%). RESULTS: 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). CONCLUSIONS: RG for cStage I/II GC is safe and feasible. It may be effective in reducing morbidity with LG.
BACKGROUND: 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. METHODS: 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%). RESULTS: 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). CONCLUSIONS: RG for cStage I/II GC is safe and feasible. It may be effective in reducing morbidity with LG.
Authors: Hong Man Yoon; Young-Woo Kim; Jun Ho Lee; Keun Won Ryu; Bang Wool Eom; Ji Yeon Park; Il Ju Choi; Chan Gyoo Kim; Jong Yeul Lee; Soo Jeong Cho; Ji Yoon Rho Journal: Surg Endosc Date: 2011-11-16 Impact factor: 4.584