Omentectomy vs Omental Preservation in Resectable Cancer

Not Applicable

Not yet recruiting

• Conditions: Cancer of Stomach
• Interventions: Other: Surgery procedure

• Registration Number: NCT05747482
• Lead Sponsor: Corporacion Parc Tauli

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-02-28
• Study Start: 2024-01-01
• Primary Completion: 2026-07-01
• Study Completion: 2031-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 569

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omentectomy	Surgery procedure	Omentectomy during cancer gastric surgery
Omental preservation	Surgery procedure	Preserval omentation during cancer gastric surgery

Primary Outcome Measures

Name	Time	Method
disease free interval	5 years	time between surgery and recurrence. Units of measure: months

Secondary Outcome Measures

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