Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial.
K Keywani, W J Eshuis, A B J Borgstein...
https://pubmed.ncbi.nlm.nih.gov/39232781Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05180864
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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates whether preserving the omentum during gastrectomy for gastric cancer is as effective as completely removing it. The study focuses on adult patients with resectable gastric cancer at specific clinical stages, aiming to understand the impact of omentum preservation on three-year overall survival. The trial is a randomized controlled, open, parallel, non-inferiority, multicenter study, exploring an important question about surgery techniques and patient outcomes. Participants will undergo either a gastrectomy with complete removal of the omentum or a gastrectomy that preserves the omentum beyond the gastroepiploic vessels. Both open and minimally invasive subtotal or total gastrectomies are included. Patients are randomly assigned to one of these two surgical approaches, with treatments monitored and compared across multiple centers. During the study, participants will be assessed for overall survival at three years, with additional outcomes measured including operative time, blood loss, complications, lymph node metastases, cancer molecular classification, quality of life, hospital stay, reoperations, and cost-effectiveness. Questionnaires will be completed at various intervals up to 24 months. Clinical and pathological data will be collected post-surgery, and long-term follow-up will assess disease-free survival and survival rates up to five years.
CONDITIONS
Brief Title
Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer
Who Can Participate
Age: 18Years +
All Genders
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 provided
- 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 (except non-melanoma skin cancer, pancreatic neuroendocrine tumor <2cm, and gastrointestinal stromal tumor <2cm), unless no evidence of disease for over three years or life expectancy over five years
- Serious concomitant systemic disorders compromising safety or study completion
- Previous gastric or omental surgery (except gastric perforation indication for thoracotomy/thoracoscopy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to hospital discharge
Participants undergo open or minimally invasive (sub)total gastrectomy with either complete omentectomy or preservation of the omentum distal to the gastroepiploic vessels. Immediate post-operative care includes hospital stay and monitoring for complications.
1 surgical visit and daily hospital care until discharge
Post-operative Follow-up
Duration - Up to 5 years after surgery
Participants are monitored for postoperative complications, readmissions, reinterventions, and reoperations within specified timeframes. Quality of life assessments and pathology evaluations are conducted during this period.
Visits at baseline, 3, 6, 9, 12, and 24 months; additional visits depending on clinical needs
Long-term Monitoring
Duration - Up to 5 years after surgery
Participants are followed to assess overall survival, disease-free survival, protocol compliance, and cost-effectiveness over multiple years after surgery.
Periodic assessments up to 5 years
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
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Research Team
S
Suzanne S. Gisbertz, MD, PhD
H
Hidde Overtoom, MD
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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