About this trial
Curative therapy for gastric cancer usually consists of perioperative chemotherapy and a radical (R0) gastrectomy. A radical resection includes a modified D2 lymphadenectomy, and, generally, a complete omentectomy, to ensure the removal of omental metastatic lymph nodes and tumor deposits.
The omentum has some essential functions within the peritoneal cavity. The omentum functions as regulator of regional immune responses to prevent infections and, additionally, it prevents adhesions that can lead to small bowel obstruction. Omentectomy is associated with increased incidence of early and late postoperative complications such as abdominal abscess, ileus, and wound infections in various types of surgery.
There is little evidence regarding survival benefit of routine complete omentectomy during gastrectomy. The investigators hypothesize that omitting a complete omentectomy (and instead preserve the greater omentum distal of the gastroepiploic arcade) during gastrectomy for cancer does not negatively impact survival.
OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Adult patients (\>18 years) with primary resectable gastric cancer, clinical stage T2-4a N0-3 M0 or cT1N+ scheduled for open or minimally invasive (sub)total gastrectomy are included. The primary study objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of three-year overall survival.
Eligibility criteria
Qualifiers
Primary resectable gastric adenocarcinoma, clinical stage T1-4aN0-3M0
ASA 1-3 (able to undergo surgery)
Scheduled for open or minimally invasive (sub)total gastrectomy with modified D2-lymphadenectomy, with or without perioperative chemotherapy
Age above 18
Disqualifiers
Gastric cancer clinically staged as T1N0
Locally advanced gastric cancer requiring multi-visceral resection
Pregnancy
Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless no evidence of disease and diagnosed more than three years before diagnosis of gastric cancer, or with a life expectancy of more than five years from date of inclusion
Trial design
Treatments tested in this trial
- Gastrectomy
Treatment groups
Sponsors and collaborators
Amsterdam UMC
Lead sponsor
Amsterdam UMC, location VUmc
Sponsor institution