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Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

NCT05180864 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 654

Last updated 2025-09-04

No results posted yet for this study

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.

Conditions

  • Stomach Neoplasm

Interventions

PROCEDURE

Gastrectomy

Open or minimally invasive (sub)total gastrectomy

Sponsors & Collaborators

  • Amsterdam UMC

    lead OTHER

Principal Investigators

  • Suzanne S. Gisberts, MD, PhD · Amsterdam UMC

  • Wietse J. Eshuis, MD, PhD · Amsterdam UMC

  • Mark I. van Berge Henegouwen, MD, PhD · Amsterdam UMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2029-01-01
Completion
2031-01-01

Countries

  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180864 on ClinicalTrials.gov