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Omentectomy vs Omental Preservation in Resectable Cancer

C

Corporacion Parc Tauli

Status

Not yet enrolling

Conditions

Cancer of Stomach

Treatments

Other: Surgery procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT05747482
SMontmany2022

Details and patient eligibility

About

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.

Enrollment

569 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

569 participants in 2 patient groups

Omentectomy
Other group
Description:
Omentectomy during cancer gastric surgery
Treatment:
Other: Surgery procedure
Omental preservation
Other group
Description:
Preserval omentation during cancer gastric surgery
Treatment:
Other: Surgery procedure

Trial contacts and locations

0

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Central trial contact

Sandra Montmany, PhD; Andrea Torrecilla, MD

Data sourced from clinicaltrials.gov

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