Safety and feasibility of reduced-port robotic distal gastrectomy for gastric cancer: a phase I/II clinical trial
- 446 Downloads
Theoretically, reducing the number of ports required in minimally invasive surgery for gastric cancer would further minimize trauma associated therewith. Advances in single-site surgery have afforded surgeons the ability to perform reduced-port distal gastrectomy via a robotic approach using the Single-Site™ system, eliminating restrictions on the movement of surgical instruments.
This phase I/II study was designed as a single-arm prospective trial of reduced-port robotic distal gastrectomy (RRDG) by a single surgeon (NCT02347956). From January to October 2015, 40 individuals scheduled to undergo robotic surgery for early gastric cancer were asked to participate in the trial. Nineteen were enrolled and underwent RRDG. The primary endpoints were 30-day morbidity and mortality.
No intraoperative event requiring conversion to laparoscopic or open surgery occurred, and no major complication was observed following RRDG (0.0% [80% CI (0.0–11.4%)]). Medians of operation time, blood loss, the number of retrieved lymph nodes, days until gas passing, and hospital stay were 190 min, 20 mL, 48, 3, and 5 days, respectively.
Deemed safe and feasible through the present trial, RRDG could be a valid alternative to conventional robot distal gastrectomy for managing early gastric cancer. Our reduced-port robotic surgery using the Single-Site system and a third robotic arm could potentially be applicable as a highly advanced, minimally invasive surgery for other solid organ diseases.
KeywordsEarly Gastric Cancer Visual Analogue Scale Score Retrieve Lymph Node Intuitive Surgical Needle Driver
Reduced-port robotic distal gastrectomy
This study was supported by Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Science, ICT & Future Planning (NRF-2013R1A1A1007706). The authors would like to thank Anthony Thomas Milliken, ELS (Editing Synthase, Seoul, Korea) for his help with the editing of this manuscript and thank Soyoung Kim, Kyoung Hee Lee, and other nursing staff members for their professional help and enthusiasm.
Compliance with ethical standards
Mrs. Youn Nam Kim, Mr. Dong-Su Jang, Drs. Seungho Lee, Jin Kyong Kim, Yoo Min Kim, Taeil Son, Woo Jin Hyung, and Hyoung-Il Kim have no conflicts of interest or financial ties to disclose.
- 3.Kim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Song KY, Ryu SY (2014) Long-term results of laparoscopic gastrectomy for gastric cancer: a large-scale case-control and case-matched Korean multicenter study. J Clin Oncol 32(7):627–633. doi: 10.1200/jco.2013.48.8551 CrossRefPubMedGoogle Scholar
- 13.Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M (2009) The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg 250(2):187–196. doi: 10.1097/SLA.0b013e3181b13ca2 CrossRefPubMedGoogle Scholar
- 16.Tokunaga M, Kondo J, Tanizawa Y, Bando E, Kawamura T, Terashima M (2012) Postoperative intra-abdominal complications assessed by the Clavien-Dindo classification following open and laparoscopy-assisted distal gastrectomy for early gastric cancer. J Gastrointest Surg 16(10):1854–1859. doi: 10.1007/s11605-012-1981-8 CrossRefPubMedGoogle Scholar
- 17.Kim SM, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S, Lee JH (2015) Comparison of reduced port totally laparoscopic distal gastrectomy (duet TLDG) and conventional laparoscopic-assisted distal gastrectomy. Ann Surg Oncol 22(8):2567–2572. doi: 10.1245/s10434-014-4333-y CrossRefPubMedGoogle Scholar