According to the findings of the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group CLASS02 study, which compared laparoscopic total gastrectomy (LTG) versus conventional open total gastrectomy (OTG) in clinical stage I gastric cancer patients, morbidity and mortality outcomes were similar for both treatments.
The researchers stated that clinical evidence supporting the safety of LTG is lacking, so they sought to compare the treatments.
The CLASS02 study “was a prospective, multicenter, open-label, noninferiority, randomized clinical trial,” explained the study authors, comparing LTG versus OTG with lymphadenectomy. Between January 2017 and September 2018, the study enrolled 227 clinical stage I gastric cancer patients, who were followed through October 2018. Patients were randomized to either LTG or OTG The main outcome was 30-day postoperative morbidity and mortality. Other outcomes included recovery courses and hospital stays.
Final analysis included 105 LTG patients and 109 OTG patients; the mean (SD) ages were 59.8 (9.4) years and 59.4 (5.2) years, respectively. Both groups were majority male (LTG, n=75 [71.4%]; OTG, n=80 [73.4%]). In the LTG group, three patients (2.9%) sustained intraoperative complications, and in the OTG group, four patients (3.7%) did (rate difference, –0.8%; 95% confidence interval [CI], –6.5% to 4.9%). The overall postoperative complication rates did not largely differ between the LTG and OTG groups (18.1% vs. 17.4%, respectively; rate difference, 0.7%; 95% CI, –9.6% to 11.0%). One death was reported in the LTG group due to intra-abdominal bleeding secondary to splenic artery hemorrhage, but the mortality rate was not significantly different between the groups (rate difference, 1.0%; 95% CI, –2.5% to 5.2%), nor was the complication severity distribution.
Reporting in JAMA Oncology, the study authors concluded, “The results of the CLASS02 trial showed that the safety of LTG with lymphadenectomy by experienced surgeons for clinical stage I gastric cancer was comparable to that of OTG.”