Actively Recruiting
Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer
Led by Amsterdam UMC · Updated on 2025-09-04
654
Participants Needed
16
Research Sites
356 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary resectable gastric adenocarcinoma, clinical stage T1-4aN0-3M0
- ASA physical status 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 years
- Able to complete questionnaires in Dutch, English, or Italian
- Written informed consent
- Esophageal invasion less than 2 cm from the upper margin of the gastric rugae as determined by endoscopy
You will not qualify if you...
- 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 less than 2 cm, and gastrointestinal stromal tumor less than 2 cm), unless no evidence of disease and diagnosed more than three years before gastric cancer diagnosis or with life expectancy over five years
- Serious systemic disorders compromising safety or study completion, at investigator's discretion
- Previous gastric or omental surgery (except gastric perforation)
- Indication for thoracotomy or thoracoscopy
AI-Screening
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Trial Site Locations
Total: 16 locations
1
University Medical Center of the Johannes Gutenberg University
Mainz, Germany
Not Yet Recruiting
2
Azienda Ospedaliera Universitaria
Siena, Italy
Not Yet Recruiting
3
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
4
Ziekenhuis Groep Twente
Almelo, Netherlands
Not Yet Recruiting
5
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Not Yet Recruiting
6
Gelre ziekenhuis
Apeldoorn, Netherlands
Not Yet Recruiting
7
Rijnstate ziekenhuis
Arnhem, Netherlands
Not Yet Recruiting
8
Catharina Ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
9
Universitait Medisch Centrum Groningen
Groningen, Netherlands
Not Yet Recruiting
10
Zuyderland ziekenhuis
Heerlen, Netherlands
Not Yet Recruiting
11
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Not Yet Recruiting
12
Leids Universitair Medisch Centrum
Leiden, Netherlands
Not Yet Recruiting
13
Erasmus Medisch Centrum
Rotterdam, Netherlands
Not Yet Recruiting
14
Elisabeth Tweesteden ziekenhuis
Tilburg, Netherlands
Not Yet Recruiting
15
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Not Yet Recruiting
16
Oxford University Hospitals
Oxford, United Kingdom
Not Yet Recruiting
Research Team
S
Suzanne S. Gisbertz, MD, PhD
CONTACT
H
Hidde Overtoom, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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