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Trial Title:
Omentectomy vs Omental Preservation in Resectable Cancer
NCT ID:
NCT05747482
Condition:
Cancer of Stomach
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Surgery procedure
Description:
Omentectomy vs omental preservations during gastric surgery
Arm group label:
Omental preservation
Arm group label:
Omentectomy
Other name:
Omentectomy
Other name:
Omental preservation
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 1, 2024
Completion date:
July 1, 2031
Lead sponsor:
Agency:
Corporacion Parc Tauli
Agency class:
Other
Source:
Corporacion Parc Tauli
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05747482
