Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer
Recruiting now · Not applicable
Conditions studied: Stomach Neoplasm
In brief
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.
Key facts
- Study ID
- NCT05180864
- Run by
- Amsterdam UMC
- People needed
- 654
- Starts
- 2024-03-01
- Expected to finish
- 2031-01-01
- Last updated by the study team
- 2025-09-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (enrolling)
- Catharina Ziekenhuis — Eindhoven, Netherlands (enrolling)
- Ziekenhuis Groep Twente — Almelo, Netherlands
- Antoni van Leeuwenhoek — Amsterdam, Netherlands
- Gelre ziekenhuis — Apeldoorn, Netherlands
- Rijnstate ziekenhuis — Arnhem, Netherlands
- Universitait Medisch Centrum Groningen — Groningen, Netherlands
- Zuyderland ziekenhuis — Heerlen, Netherlands
- Medisch Centrum Leeuwarden — Leeuwarden, Netherlands
- Leids Universitair Medisch Centrum — Leiden, Netherlands
- Erasmus Medisch Centrum — Rotterdam, Netherlands
- Elisabeth Tweesteden ziekenhuis — Tilburg, Netherlands
- Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
- University Medical Center of the Johannes Gutenberg University — Mainz, Germany
- Oxford University Hospitals — Oxford, United Kingdom
- Azienda Ospedaliera Universitaria — Siena, Italy
Full record on ClinicalTrials.gov
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