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Omentectomy vs Omental Preservation in Resectable Cancer

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05747482
Collaborator
(none)
569
Enrollment
2
Arms
90
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Surgery procedure
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
569 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Non-inferiority Randomized Clinical Trial Comparing Omenectomy and Omental Preservation in Resectable Gastric Cancer
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2031

Arms and Interventions

Arm Intervention/Treatment
Other: Omentectomy

Omentectomy during cancer gastric surgery

Other: Surgery procedure
Omentectomy vs omental preservations during gastric surgery
Other Names:
  • Omentectomy
  • Omental preservation

    		•
    Other: Omental preservation

    Preserval omentation during cancer gastric surgery

    Other: Surgery procedure
    Omentectomy vs omental preservations during gastric surgery
    Other Names:
  • Omentectomy
  • Omental preservation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. disease free interval [5 years]

      time between surgery and recurrence. Units of measure: months

    Secondary Outcome Measures

    1. global survival [5 years]

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

    2. survival at 5 years [5 years]

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

    3. complications - CCI [30 days after surgery]

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

    4. postoperatory mortality [30 days after surgery]

      mortality after surgery. Units of measure: percentage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Corporacion Parc Tauli

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sandra Montmany-Vioque, MD, PhD, Corporacion Parc Tauli
    ClinicalTrials.gov Identifier:
    NCT05747482
    Other Study ID Numbers:
    • SMontmany2022
    First Posted:
    Feb 28, 2023
    Last Update Posted:
    Feb 28, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Feb 28, 2023