Omentectomy vs Omental Preservation in Resectable Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgery procedure.
- Who it may be relevant to
- Registry conditions: Cancer of Stomach. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Non-inferiority Randomized Clinical Trial Comparing Omenectomy and Omental Preservation in Resectable Gastric Cancer
Overview
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.
Interventions
- Other Surgery procedure
Omentectomy vs omental preservations during gastric surgery
Primary outcome measures
- disease free interval [Time frame: 5 years]
Secondary outcome measures (4)
- global survival [Time frame: 5 years]
- survival at 5 years [Time frame: 5 years]
- complications - CCI [Time frame: 30 days after surgery]
- postoperatory mortality [Time frame: 30 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05747482 · SMontmany2022