Morbidity and mortality of elderly patients with advanced gastric cancer after laparoscopy-assisted or open distal gastrectomy: a randomized-controlled trial.

Laparoscopy-assisted distal gastrectomy (LDG) combined with D2 lymphadenectomy may be safely performed in patients with advanced gastric cancer (AGC) by experienced surgeons at specialized high-volume institutions as shown in the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS)-01. However, studies focusing on the use of LDG in patients with gastric cancer older than 65 years are rare. This study was designed to investigate the morbidity and mortality of elderly patients with gastric cancer who underwent laparoscopic-assisted or open distal gastrectomy (ODG). In this prospective, randomized, open, parallel controlled trial, patients older than 65 years with tumor located at the middle or lower part of the stomach will be enrolled in this study. Patients will be randomly divided into a laparoscopic group and an open surgery group. The early post-operative complications, intra-operative complications and post-operative recovery will be compared between the two groups. This trial will provide valuable clinical evidence for the objective assessment of the feasibility, short-term safety, and potential benefits of LDG compared with ODG for gastric cancer in the elderly patients. This trial has been registered on ClinicalTrials.gov. (Identifier: NCT02246153.) in September 22, 2014.