EICHORCondition: Stomach Neoplasm · Sponsor: Amsterdam UMC
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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.
This description comes directly from the study's public registry record.
Suzanne S. Gisbertz, MD, PhD · 0031204444444 · s.s.gisbertz@amsterdamumc.nl
Hidde Overtoom, MD · 0031630428132 · h.c.g.overtoom@amsterdamumc.nl
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| University Medical Center of the Johannes Gutenberg University | Mainz, Germany | Not Yet Recruiting |
| Azienda Ospedaliera Universitaria | Siena, Italy | Not Yet Recruiting |
| Amsterdam UMC | Amsterdam, North Holland, Netherlands | Recruiting |
| Ziekenhuis Groep Twente | Almelo, Netherlands | Not Yet Recruiting |
| Antoni van Leeuwenhoek | Amsterdam, Netherlands | Not Yet Recruiting |
| Gelre ziekenhuis | Apeldoorn, Netherlands | Not Yet Recruiting |
| Rijnstate ziekenhuis | Arnhem, Netherlands | Not Yet Recruiting |
| Catharina Ziekenhuis | Eindhoven, Netherlands | Recruiting |
| Universitait Medisch Centrum Groningen | Groningen, Netherlands | Not Yet Recruiting |
| Zuyderland ziekenhuis | Heerlen, Netherlands | Not Yet Recruiting |
| Medisch Centrum Leeuwarden | Leeuwarden, Netherlands | Not Yet Recruiting |
| Leids Universitair Medisch Centrum | Leiden, Netherlands | Not Yet Recruiting |
+ 4 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT05180864