NCT05180864Recruiting
Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer
Source: ClinicalTrials.gov · Last updated 4 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 654 (estimated)
- First submitted
- 3 Jun 2021
- Start date
- 1 Mar 2024
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Amsterdam UMC
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05180864
What you commit to
- Study type: Interventional
- Planned participants: 654
- From 1 Mar 2024 to the primary completion date, 1 Jan 2029
- 16 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Gastric cancer clinically staged as T1N0
- Locally advanced gastric cancer requiring multi-visceral resection
- 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
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center of the Johannes Gutenberg University Coordinator of this site? Confirm its status | Mainz | Germany | Not yet recruiting |
| Oxford University Hospitals Coordinator of this site? Confirm its status | Oxford | United Kingdom | Not yet recruiting |
| Azienda Ospedaliera Universitaria Coordinator of this site? Confirm its status | Siena | Italy | Not yet recruiting |
| Ziekenhuis Groep Twente Coordinator of this site? Confirm its status | Almelo | Netherlands | Not yet recruiting |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Antoni van Leeuwenhoek Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Gelre ziekenhuis Coordinator of this site? Confirm its status | Apeldoorn | Netherlands | Not yet recruiting |
| Rijnstate Ziekenhuis Coordinator of this site? Confirm its status | Arnhem | Netherlands | Not yet recruiting |
| Catharina Ziekenhuis Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Universitait Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Not yet recruiting |
| Zuyderland ziekenhuis Coordinator of this site? Confirm its status | Heerlen | Netherlands | Not yet recruiting |
| Medisch Centrum Leeuwarden Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Not yet recruiting |
| Leids Universitair Medisch Centrum Coordinator of this site? Confirm its status | Leiden | Netherlands | Not yet recruiting |
| Erasmus Medisch Centrum Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Elisabeth-Tweesteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Not yet recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.