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RECRUITING
NCT05180864
NA

Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

Sponsor: Amsterdam UMC

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

654

Start Date

2024-03-01

Completion Date

2031-01-01

Last Updated

2025-09-04

Healthy Volunteers

No

Interventions

PROCEDURE

Gastrectomy

Open or minimally invasive (sub)total gastrectomy

Locations (16)

University Medical Center of the Johannes Gutenberg University

Mainz, Germany

Azienda Ospedaliera Universitaria

Siena, Italy

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Ziekenhuis Groep Twente

Almelo, Netherlands

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Gelre ziekenhuis

Apeldoorn, Netherlands

Rijnstate ziekenhuis

Arnhem, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Universitait Medisch Centrum Groningen

Groningen, Netherlands

Zuyderland ziekenhuis

Heerlen, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Elisabeth Tweesteden ziekenhuis

Tilburg, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Oxford University Hospitals

Oxford, United Kingdom