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RECRUITINGINTERVENTIONAL

Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form - Esophageal invasion \< 2 cm defined from the upper margin of the gastric rugae as determined by endoscopy Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Gastrectomy

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