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NCT05747482 Clinical Trial

Omentectomy vs Omental Preservation in Resectable Cancer

Cancer of Stomach Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05747482
Other study ID # SMontmany2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date July 1, 2031

Study information
Verified date February 2023
Source Corporacion Parc Tauli
Contact Sandra Montmany, PhD
Phone 937231010
Email smontmany@tauli.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 569
Est. completion date July 1, 2031
Est. primary completion date July 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Corporacion Parc Tauli

Outcome
Type Measure Description Time frame Safety issue
Primary disease free interval time between surgery and recurrence. Units of measure: months 5 years
Secondary global survival survival between surgery and last follow-up date. Units of measure: percentage 5 years
Secondary survival at 5 years survival between surgery and 5 years. Units of measure: percentage 5 years
Secondary complications - CCI type of complications and CCI number. Units of measure: enter number between 1 and 100 30 days after surgery
Secondary postoperatory mortality mortality after surgery. Units of measure: percentage 30 days after surgery
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