Clinical Trial

Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

Study acronym: OMEGA-2
Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-12-18; most recent amendment 2025-08-28.
Status change: Not Yet Recruiting → Recruiting 2024-03-28
Trial Details
NCT Number NCT05180864
Lead Sponsor Amsterdam UMC
Conditions Stomach Neoplasm
Enrollment 654 participants
Start Date 2024-03-01
Primary Completion 2029-01-01 (estimated)
Study Completion 2031-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-04