TY - JOUR
T1 - Clinical advantages of robotic gastrectomy for clinical stage I/II gastric cancer
T2 - a multi-institutional prospective single-arm study
AU - Uyama, Ichiro
AU - Suda, Koichi
AU - Nakauchi, Masaya
AU - Kinoshita, Takahiro
AU - Noshiro, Hirokazu
AU - Takiguchi, Shuji
AU - Ehara, Kazuhisa
AU - Obama, Kazutaka
AU - Kuwabara, Shiro
AU - Okabe, Hiroshi
AU - Terashima, Masanori
N1 - Publisher Copyright:
© 2018, The International Gastric Cancer Association and The Japanese Gastric Cancer Association.
PY - 2019/3/15
Y1 - 2019/3/15
N2 - 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/m 2 , 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.
AB - 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/m 2 , 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.
KW - Gastrectomy
KW - Minimally invasive surgical procedures
KW - Postoperative complications
KW - Robotic surgical procedure
KW - Stomach neoplasms
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U2 - 10.1007/s10120-018-00906-8
DO - 10.1007/s10120-018-00906-8
M3 - Article
C2 - 30506394
AN - SCOPUS:85058035793
SN - 1436-3291
VL - 22
SP - 377
EP - 385
JO - Gastric Cancer
JF - Gastric Cancer
IS - 2
ER -