Clinical trial · Interventional
Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasm | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Complete omentectomy
- description
- Gastrectomy with complete omentectomy
- interventionNames
- Procedure: Gastrectomy
- type
- EXPERIMENTAL
- label
- Omentum presevation
- description
- Gastrectomy with preservation of the omentum distal to the gastroepiploic vessels
- interventionNames
- Procedure: Gastrectomy
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 3 years after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDKeywani K, Eshuis WJ, Borgstein ABJ, van Det MJ, van Duijvendijk P, van Etten B, Grimminger PP, Heisterkamp J, Lagarde SM, Luyer MDP, Markar SR, Meijer SL, Pierie JPEN, Roviello F, Ruurda JP, van Sandick JW, Sosef M, Witteman BPL, de Steur WO, Lissenberg-Witte BI, van Berge Henegouwen MI, Gisbertz SS. Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial. Trials. 2024 Sep 4;25(1):588. doi: 10.1186/s13063-024-08396-z. PMID 39232781