NCT05180864 Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer
| NCT ID | NCT05180864 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amsterdam UMC |
| Condition | Stomach Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 654 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 654 participants in total. It began in 2024-03-01 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion criteria * 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 Exclusion Criteria: * Gastric cancer clinically staged as T1N0 * Locally advanced gastric cancer requiring multi-visceral resection * Pregnancy * Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) \<2cm, and gastrointestinal stromal tumor (GIST) \<2cm), unless no evidence of disease and diagnosed more than three years before diagnosis of gastric cancer, or with a life expectancy of more than five years from date of inclusion * 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 * Previous gastric or omental surgery, with the exclusion of a gastric perforation Indication for thoracotomy/thoracoscopy
Contact & Investigator
Suzanne S. Gisberts, MD, PhD
STUDY CHAIR
Amsterdam UMC
Frequently Asked Questions
Who can join the NCT05180864 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stomach Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05180864 currently recruiting?
Yes, NCT05180864 is actively recruiting participants. Contact the research team at s.s.gisbertz@amsterdamumc.nl for enrollment information.
Where is the NCT05180864 trial being conducted?
This trial is being conducted at Mainz, Germany, Siena, Italy, Amsterdam, Netherlands, Almelo, Netherlands and 11 additional locations.
Who is sponsoring the NCT05180864 clinical trial?
NCT05180864 is sponsored by Amsterdam UMC. The principal investigator is Suzanne S. Gisberts, MD, PhD at Amsterdam UMC. The trial plans to enroll 654 participants.