NCT05180864

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
654

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
4 countries

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Mar 2024Jan 2031

First Submitted

Initial submission to the registry

June 3, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
2.2 years until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

4.8 years

First QC Date

June 3, 2021

Last Update Submit

August 28, 2025

Conditions

Stomach Neoplasm

Keywords

GastrectomyOmentectomySurvival

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival is defined as the period of time from operation to death from any cause. Patients alive and free of all these events will be censored at the last follow-up

    3 years after surgery

Secondary Outcomes (16)

  • 5-year overall survival

    5 years after surgery

  • Intraoperative blood loss

    Intraoperative

  • Postoperative complications

    Within 30-days after surgery

  • Distribution of lymph node metastases

    Pathology report 1/2 weeks after surgery

  • R0-resection rate

    Pathology report 1/2 weeks after surgery

  • +11 more secondary outcomes

Study Arms (2)

Complete omentectomy

ACTIVE COMPARATOR

Gastrectomy with complete omentectomy

Procedure: Gastrectomy

Omentum presevation

EXPERIMENTAL

Gastrectomy with preservation of the omentum distal to the gastroepiploic vessels

Procedure: Gastrectomy

Interventions

GastrectomyPROCEDURE

Open or minimally invasive (sub)total gastrectomy

Complete omentectomyOmentum presevation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Gastric cancer clinically staged as T1N0
  • Locally advanced gastric cancer requiring multi-visceral resection
  • Pregnancy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University Medical Center of the Johannes Gutenberg University

Mainz, Germany

NOT YET RECRUITING

Azienda Ospedaliera Universitaria

Siena, Italy

NOT YET RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Ziekenhuis Groep Twente

Almelo, Netherlands

NOT YET RECRUITING

Antoni van Leeuwenhoek

Amsterdam, Netherlands

NOT YET RECRUITING

Gelre ziekenhuis

Apeldoorn, Netherlands

NOT YET RECRUITING

Rijnstate ziekenhuis

Arnhem, Netherlands

NOT YET RECRUITING

Catharina Ziekenhuis

Eindhoven, Netherlands

RECRUITING

Universitait Medisch Centrum Groningen

Groningen, Netherlands

NOT YET RECRUITING

Zuyderland ziekenhuis

Heerlen, Netherlands

NOT YET RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

NOT YET RECRUITING

Leids Universitair Medisch Centrum

Leiden, Netherlands

NOT YET RECRUITING

Erasmus Medisch Centrum

Rotterdam, Netherlands

NOT YET RECRUITING

Elisabeth Tweesteden ziekenhuis

Tilburg, Netherlands

NOT YET RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

NOT YET RECRUITING

Oxford University Hospitals

Oxford, United Kingdom

NOT YET RECRUITING

Related Publications (1)

  • Keywani K, Eshuis WJ, Borgstein ABJ, van Det MJ, van Duijvendijk P, van Etten B, Grimminger PP, Heisterkamp J, Lagarde SM, Luyer MDP, Markar SR, Meijer SL, Pierie JPEN, Roviello F, Ruurda JP, van Sandick JW, Sosef M, Witteman BPL, de Steur WO, Lissenberg-Witte BI, van Berge Henegouwen MI, Gisbertz SS. Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial. Trials. 2024 Sep 4;25(1):588. doi: 10.1186/s13063-024-08396-z.

    PMID: 39232781BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Suzanne S. Gisberts, MD, PhD

    Amsterdam UMC

    STUDY CHAIR

  • Wietse J. Eshuis, MD, PhD

    Amsterdam UMC

    PRINCIPAL INVESTIGATOR

  • Mark I. van Berge Henegouwen, MD, PhD

    Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne S. Gisbertz, MD, PhD

CONTACT

0031204444444s.s.gisbertz@amsterdamumc.nl

Hidde Overtoom, MD

CONTACT

0031630428132h.c.g.overtoom@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2021

First Posted

January 6, 2022

Study Start

March 1, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2031

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)DE(1)NL(13)GB(1)