Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

Launched by AMSTERDAM UMC · Dec 18, 2021

Keywords

ClinConnect Summary

The OMEGA trial is studying whether it's safe to skip the removal of a part of the omentum, a layer of fat in the abdomen that plays important roles in protecting against infections and preventing complications after surgery, during gastric cancer surgery. Usually, doctors remove the entire omentum to ensure they eliminate cancerous cells, but this study aims to find out if leaving part of it in place can still lead to similar survival rates for patients. Participants in this trial are adults over 18 years old who have a specific stage of gastric cancer and are scheduled for surgery.

To be eligible, patients must have a type of stomach cancer that can be surgically treated and must not have had previous major stomach surgery. They also need to be healthy enough to undergo surgery and able to communicate in Dutch, English, or Italian. If you join this study, you'll be randomly assigned to one of two groups: one will have the complete omentum removed, while the other will keep part of it. Doctors will closely monitor your health and recovery, looking at overall survival rates over three years. This trial is important because it could help reduce complications after surgery while still providing effective cancer treatment.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 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
• • Able to complete questionnaires in Dutch, English or Italian
• • Written informed consent
• • Esophageal invasion \< 2 cm defined from the upper margin of the gastric rugae as determined by endoscopy
• Exclusion Criteria:
• • 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
• • Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator
• • Previous gastric or omental surgery, with the exclusion of a gastric perforation Indication for thoracotomy/thoracoscopy