Comparing omentum preservation to complete omentectomy during gastrectomy for gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates whether preserving the omentum during gastrectomy for gastric cancer is as effective as complete omentectomy in terms of three-year overall survival. The study involves patients with primary resectable gastric adenocarcinoma who are scheduled for gastrectomy. It compares various outcomes between the two approaches, including operating time, complications, and quality of life. The trial aims to determine if omitting complete omentectomy can reduce postoperative complications without compromising survival rates.

Why it matters

Who can join: the full rules

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

Where it's running

• Amsterdam UMC
  Amsterdam, North Holland, Netherlands Recruiting
• Catharina Ziekenhuis
  Eindhoven, Netherlands Recruiting
• University Medical Center of the Johannes Gutenberg University
  Mainz, Germany Not yet recruiting
• Azienda Ospedaliera Universitaria
  Siena, Italy Not yet recruiting
• Ziekenhuis Groep Twente
  Almelo, Netherlands Not yet recruiting
• Antoni van Leeuwenhoek
  Amsterdam, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Wietse J. Eshuis, MD, PhD — Amsterdam UMC
• Study coordinator: Suzanne S. Gisbertz, MD, PhD
• Email: s.s.gisbertz@amsterdamumc.nl
• Phone: 0031204444444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.