Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05747482

Omentectomy vs Omental Preservation in Resectable Cancer

European clinical guidelines do not establish a clear recommendation neither for nor against omentectomy of this segment, the American clinical guidelines recommend omentectomy in view of its potential long-term oncological benefit, and Japanese clinical guidelines only recommend 2nd segment omentectomy in locally advanced gastric cancers (stage T3-T4) recommending omental preservation in early gastric cancers (stage T1-T2).

Faced with this lack of consensus, we propose a randomized, prospective and multicentric study in patients with resectable gastric cancer in stage T3-4 N+/- M0. Patients will be randomized into two groups, one where omentectomy of the 2nd omental portion will be performed and another where omental preservation will be performed.

The aim of our study is to analyze the disease-free interval and survival between both groups, also comparing postoperative complications and mortality.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older than 18 years old
  • Resectable gastric cancer
  • Gastric cancer T3-4 N+/- M0

Exclusion criteria

  • M1
  • Non surgical patients for medical status
  • Non resectable gastric cancer during surgery
  • Endoscopic resectable gastric cancer

Treatment and study plan

Surgery procedure

Other

Omentectomy vs omental preservations during gastric surgery

Other names: Omentectomy, Omental preservation

Primary outcomes

  1. disease free interval

    Time frame: 5 years

    time between surgery and recurrence. Units of measure: months

Secondary outcomes

  1. global survival

    Time frame: 5 years

    survival between surgery and last follow-up date. Units of measure: percentage

  2. survival at 5 years

    Time frame: 5 years

    survival between surgery and 5 years. Units of measure: percentage

  3. complications - CCI

    Time frame: 30 days after surgery

    type of complications and CCI number. Units of measure: enter number between 1 and 100

  4. postoperatory mortality

    Time frame: 30 days after surgery

    mortality after surgery. Units of measure: percentage

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Torrecilla, MD

CONTACT

[email protected]

937231010 ext. 21490

Sandra Montmany, PhD

CONTACT

[email protected]

937231010 ext. 21490

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

Non-inferiority Randomized Clinical Trial Comparing Omenectomy and Omental Preservation in Resectable Gastric Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2031
First posted
Feb 28, 2023
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.