Morbidity and mortality after laparoscopic gastrectomy for advanced gastric cancer: Results of a phase II clinical trial

Background: Very few reports are available on laparoscopic gastrectomy (LG) for advanced gastric cancer (AGC) patients. We therefore conducted a prospective phase II clinical trial to address the feasibility of LG in AGC. Morbidity and mortality were evaluated. Methods: The eligibility criteria were as follows: 20-80 years of age, cT2N0-cT4aN2, American Society of Anesthesiologists score of 3 or less, and no other malignancy. A total of 204 patients were enrolled onto this study. Of these, 16 were excluded because far-advanced stages of disease were identified after laparoscopic exploration, and 31 were excluded because early gastric cancer was diagnosed postoperatively. All patients underwent a D2 lymphadenectomy. Morbidity was stratified according to the Clavien-Dindo classification. Results: Conversion to open surgery occurred in 11 patients (7.0 %). The mean hospital stay was 6.3 days for distal gastrectomy and 8.5 days for total gastrectomy. The mean number of collected lymph nodes was 52.7 for distal gastrectomy and 63.8 for total gastrectomy. The rates of local and systemic complications of grade II or more were 8.3 and 3.2 %. One patient died of operative complications. In multivariate analysis, old age (>70 years) was an independent risk factor for complications, and old age and Billroth I anastomosis were predictable risk factors for local complications. Conclusions: LG with D2 lymphadenectomy was safe and technically feasible for the treatment of AGC, with acceptable rate of morbidity and mortality. ClinicalTrial.gov Registration: NCT01441336.