The STOMACH trial: Surgical Technique, Open versus Minimally invasive gastrectomy After Chemotherapy

Jennifer Straatman, MD, M.A. Cuesta, MD, PhD, S.S. Gisbertz, MD, PhD, D.l. van der Peet, Md, PhD. VU Medical Centre, Amsterdam.

Objective
Aim of this prospective randomised, multi-center trial is to compare open gastrectomy with minimally invasive gastrectomy for gastric cancer in patients that received neoadjuvant therapy.
Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. All while maintaining similar results with regard to tumour resection margin and oncological long-term survival. In gastric cancer the role of laparoscopic surgery remains unclear.
Current recommended treatment for gastric cancer consists of radical resection of the stomach with a free margin of 5-6 cm from the tumour, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, It is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield.

Methods
Double-blind randomisation of patients between open gastrectomy, or minimally invasive gastrectomy. Primary endpoint is quality of oncological resection with regard to radicality and lymph nodes dissection. Secondary endpoints include postoperative complications, mortality and Quality of Life as measured by Patient Related Outcome Measures (PROM), the SF-36 and GIQLI score.

Preliminary Results
Several studies have focussed on laparoscopic versus open gastrectomy. However, these studies are predominantly conducted in Asian countries, where incidence of gastric cancer is higher. The screening program in Japan, which started in 1983, has enabled early detection and treatment of gastric carcinomas in these countries. As such, tumour stages are lower at the time of diagnosis compared to Western countries. Therefore it is difficult to translate the results of Asian studies to the Western population.
Only a few Western studies were conducted that compare laparoscopic and open approaches for gastric cancer. An important previous finding is that laparoscopic gastrectomy showed similar results to open gastrectomy with regard to quality of oncological resection, as measured by the number of retrieved lymph nodes, and five-year survival. Whereas patient recovery was faster and admission duration shorter.

Conclusions/Expectations
Preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the West they are often underpowered. Furthermore these studies were conducted before implementation of neoadjuvant therapy. A prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy.

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