Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05180864 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

Study acronym: OMEGA-2
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Publications: details revised at 1 of 1 entryv4
  2. Notable Lead sponsor: VU University of Amsterdam to Amsterdam UMC
    • Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 15 to 16
    • Start date changed from estimate of Jan 1, 2024 to Mar 1, 2024
    v3
  3. Notable Primary completion date: Oct 2027 to Jan 1, 2029v2 Show 5 more changesShow less
    • Start date: Nov 2022 to Jan 1, 2024
    • Study completion date: Dec 2027 to Jan 1, 2031
    • Study description shortened, about 56 words
    • Study sites revised (15)
    • Eligibility criteria shortened, about 2 words
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05180864
Lead Sponsor Amsterdam UMC
Conditions
(from sponsor)
Stomach Neoplasm
Related terms Stomach Neoplasms
Enrollment 654 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov