Omentectomy vs Omental Preservation in Resectable Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer of Stomach

Intervention / Treatment
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* Other: Surgery procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Omentectomy<br>Omentectomy during cancer gastric surgery | Other: Surgery procedure<br>* Omentectomy vs omental preservations during gastric surgery<br>* Other names: Omental preservation;|
| Other: Omental preservation<br>Preserval omentation during cancer gastric surgery | Other: Surgery procedure<br>* Omentectomy vs omental preservations during gastric surgery<br>* Other names: Omental preservation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free interval | time between surgery and recurrence. Units of measure: months | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global survival | survival between surgery and last follow-up date. Units of measure: percentage | 5 years | 
| survival at 5 years | survival between surgery and 5 years. Units of measure: percentage | 5 years | 
| complications - CCI | type of complications and CCI number. Units of measure: enter number between 1 and 100 | 30 days after surgery | 
| postoperatory mortality | mortality after surgery. Units of measure: percentage | 30 days after surgery |