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Omentectomy vs Omental Preservation in Resectable Cancer

NCT ID: NCT05747482

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

569 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2031-07-01

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.

Detailed Description

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Conditions

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Cancer of Stomach

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Omentectomy

Omentectomy during cancer gastric surgery

Group Type OTHER

Surgery procedure

Intervention Type OTHER

Omentectomy vs omental preservations during gastric surgery

Omental preservation

Preserval omentation during cancer gastric surgery

Group Type OTHER

Surgery procedure

Intervention Type OTHER

Omentectomy vs omental preservations during gastric surgery

Interventions

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Surgery procedure

Omentectomy vs omental preservations during gastric surgery

Intervention Type OTHER

Other Intervention Names

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Omentectomy Omental preservation

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Sandra Montmany-Vioque

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sandra Montmany, PhD

Role: CONTACT

Phone: 937231010

Email: [email protected]

Andrea Torrecilla, MD

Role: CONTACT

Phone: 937231010

Email: [email protected]

Other Identifiers

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SMontmany2022

Identifier Type: -

Identifier Source: org_study_id