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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
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

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Medical Center of the Johannes Gutenberg University
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MainzGermanyNot yet recruiting
Oxford University Hospitals
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OxfordUnited KingdomNot yet recruiting
Azienda Ospedaliera Universitaria
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SienaItalyNot yet recruiting
Ziekenhuis Groep Twente
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AlmeloNetherlandsNot yet recruiting
Amsterdam UMC
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AmsterdamNetherlandsRecruiting
Antoni van Leeuwenhoek
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AmsterdamNetherlandsNot yet recruiting
Gelre ziekenhuis
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ApeldoornNetherlandsNot yet recruiting
Rijnstate Ziekenhuis
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ArnhemNetherlandsNot yet recruiting
Catharina Ziekenhuis
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EindhovenNetherlandsRecruiting
Universitait Medisch Centrum Groningen
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GroningenNetherlandsNot yet recruiting
Zuyderland ziekenhuis
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HeerlenNetherlandsNot yet recruiting
Medisch Centrum Leeuwarden
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LeeuwardenNetherlandsNot yet recruiting
Leids Universitair Medisch Centrum
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LeidenNetherlandsNot yet recruiting
Erasmus Medisch Centrum
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RotterdamNetherlandsNot yet recruiting
Elisabeth-Tweesteden Ziekenhuis
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TilburgNetherlandsNot yet recruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.