Comparing omentum preservation to complete omentectomy during gastrectomy for gastric cancer
Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer
NA · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT05180864
This study tests if keeping part of the omentum during stomach surgery for gastric cancer helps patients live as long as removing it completely, while also looking at recovery and quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 654 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Drugs / interventions | chemotherapy |
| Locations | 16 sites (Mainz and 15 other locations) |
| Trial ID | NCT05180864 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with primary resectable gastric adenocarcinoma who can undergo surgery and complete questionnaires in Dutch, English, or Italian.
Not a fit: Patients with locally advanced gastric cancer requiring multi-visceral resection or those with serious concomitant systemic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer postoperative complications and improved quality of life for gastric cancer patients.
How similar studies have performed: There is limited evidence regarding the survival benefit of routine complete omentectomy, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Mainz and 15 other locations
- 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)
- Erasmus Medisch Centrum — Rotterdam, Netherlands (NOT_YET_RECRUITING)
- Elisabeth Tweesteden ziekenhuis — Tilburg, Netherlands (NOT_YET_RECRUITING)
- Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (NOT_YET_RECRUITING)
- Oxford University Hospitals — Oxford, United Kingdom (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stomach Neoplasm, Gastrectomy, Omentectomy, Survival