Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Medical Center of the Johannes Gutenberg University
NOT_YET_RECRUITING
Mainz
Italy
Azienda Ospedaliera Universitaria
NOT_YET_RECRUITING
Siena
Netherlands
Ziekenhuis Groep Twente
NOT_YET_RECRUITING
Almelo
Amsterdam UMC
RECRUITING
Amsterdam
Antoni van Leeuwenhoek
NOT_YET_RECRUITING
Amsterdam
Gelre ziekenhuis
NOT_YET_RECRUITING
Apeldoorn
Rijnstate ziekenhuis
NOT_YET_RECRUITING
Arnhem
Catharina Ziekenhuis
RECRUITING
Eindhoven
Universitait Medisch Centrum Groningen
NOT_YET_RECRUITING
Groningen
Zuyderland ziekenhuis
NOT_YET_RECRUITING
Heerlen
Medisch Centrum Leeuwarden
NOT_YET_RECRUITING
Leeuwarden
Leids Universitair Medisch Centrum
NOT_YET_RECRUITING
Leiden
Erasmus Medisch Centrum
NOT_YET_RECRUITING
Rotterdam
Elisabeth Tweesteden ziekenhuis
NOT_YET_RECRUITING
Tilburg
Universitair Medisch Centrum Utrecht
NOT_YET_RECRUITING
Utrecht
United Kingdom
Oxford University Hospitals
NOT_YET_RECRUITING
Oxford
Contact Information
Primary
Suzanne S. Gisbertz, MD, PhD
s.s.gisbertz@amsterdamumc.nl
0031204444444
Backup
Hidde Overtoom, MD
h.c.g.overtoom@amsterdamumc.nl
0031630428132
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2031-01-01
Participants
Target number of participants: 654
Treatments
Active_comparator: Complete omentectomy
Gastrectomy with complete omentectomy
Experimental: Omentum presevation
Gastrectomy with preservation of the omentum distal to the gastroepiploic vessels
Related Therapeutic Areas
Sponsors
Leads: Amsterdam UMC

This content was sourced from clinicaltrials.gov