The study was done to compare the safety of LTG for clinical stage I gastric cancer with that of conventional OTG.
The CLASS Group CLASS02 study was a prospective, multicenter, open-label, noninferiority, randomized clinical trial that compared the safety of LTG vs OTG with lymphadenectomy for patients with clinical stage I gastric cancer.
The primary outcome was the morbidity and mortality within 30 days following surgeries between LTG and OTG with a non-inferiority margin of 10%. The secondary outcomes were recovery courses and postoperative hospital stays.
214 patients were analyzed for morbidity and mortality. Intraoperative complications occurred in 3 patients in the LTG group and 4 patients in the OTG group. There was no significant difference in the overall postoperative complication rate of 18.1% in the LTG group and 17.4% in the OTG group. One patient in the LTG group died from intra-abdominal bleeding secondary to splenic artery hemorrhage. However, there was no significant difference in mortality between the LTG group and the OTG group, and the distribution of complication severity was similar between the 2 groups.
The study concluded that the safety of LTG with lymphadenectomy by experienced surgeons for clinical stage I gastric cancer was comparable to that of OTG.