A prospective randomized study comparing open versus laparoscopy-assisted D2 radical gastrectomy in advanced gastric cancer.

BACKGROUND: In recent years, many clinical studies have confirmed the value of laparoscopy-assisted gastrectomy (LAG) in gastric cancer surgery, especially in early stages. But the safety and oncologic adequacy of laparoscopy-assisted D2 radical gastrectomy for advanced gastric cancer are still in debate. We conducted a prospective randomized trial to compare open versus laparoscopy-assisted D2 radical gastrectomy in advanced gastric cancer.
METHODS: For this study, 123 patients who had been diagnosed endoscopically with gastric cancer were randomly assigned to either LAG (n = 61) or open gastrectomy (OG) (n = 62) which ran from March 2008 to December 2009. Clinical characteristics, operative findings, postoperative recovery, morbidity, pathological report and survival rate were compared. D2 lymph node dissection was performed in 49 patients in the LAG group and 47 patients in the OG group with advanced gastric cancer. We adopt sub-group analysis in this paper.
RESULTS: The clinical characteristics of patients in the LAG and OG groups who were in the advanced stage, included age, sex, BMI and concurrent illness, and their ECOG scores were well matched. Operative findings, postoperative recovery, morbidity, pathological findings including tumor location, depth of invasion, TNM stage, histological grade and surgical extension in the two groups were also similar. Compared to the OG group, the mean operating time was significantly longer for the LAG group (267.88 ± 54.284 min in the LAG group vs. 182.02 ± 41.016 min in the OG group, p = 6.383 × 10(-13)); the mean number of days when body temperature exceeded 37°C was significantly shorter in the LAG group (p = 6.34 × 10(-8)). There were no postoperative deaths in both the groups. The postoperative morbidity rate was 12.24% in the LAG group and 19.15% in the OG group with no significant difference (p = 0.357). However, pulmonary infection was observed more frequently in the OG group (p = 0.038). After a mean follow-up of 22.1354 months (from 4 to 36 months), 14 and 15 patients died of gastric cancer in the LAG and OG groups, respectively. Two and one patient died of nongastric cancer in the LAG and OG groups, respectively. The overall survival rates were 67.1% and 53.8% in the LAG and OG groups, respectively. The estimated mean survival time was 29.387 months in the LAG group and 28.978 months in the OG group. There was no statistically significant difference in the overall survival rate for patients in both groups - LAG and OG (log-rank test, p = 0.911, Tarone Ware test, p = 0.994, and Breslow test, p = 0. 961).
CONCLUSION: LAG with D2 lymph node dissection is a safe and feasible procedure with adequate lymphadenectomy, good curability and survival rate for the treatment of advanced gastric cancer.

RCT Entities:   Population Interventions Outcomes