Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05180864

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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