RecruitingNot ApplicableNCT05180864

Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer


Sponsor

Amsterdam UMC

Enrollment

654 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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

Interventions

PROCEDUREGastrectomy

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

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NCT05180864


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