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Omentectomy vs Omental Preservation in Resectable Cancer

Primary Purpose

Cancer of Stomach

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Surgery procedure

About this trial

This is an interventional treatment trial for Cancer of Stomach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Omentectomy

Omental preservation

Arm Description

Omentectomy during cancer gastric surgery

Preserval omentation during cancer gastric surgery

Outcomes

Primary Outcome Measures

disease free interval

time between surgery and recurrence. Units of measure: months

Secondary Outcome Measures

global survival

survival between surgery and last follow-up date. Units of measure: percentage

survival at 5 years

survival between surgery and 5 years. Units of measure: percentage

complications - CCI

type of complications and CCI number. Units of measure: enter number between 1 and 100

postoperatory mortality

mortality after surgery. Units of measure: percentage

Full Information

NCT ID

NCT05747482

First Posted

February 7, 2023

Last Updated

February 16, 2023

Sponsor

Corporacion Parc Tauli

1. Study Identification

Unique Protocol Identification Number

NCT05747482

Brief Title

Omentectomy vs Omental Preservation in Resectable Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2024 (Anticipated)

Primary Completion Date

July 1, 2026 (Anticipated)

Study Completion Date

July 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Corporacion Parc Tauli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of Stomach

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

569 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Omentectomy

Arm Type

Other

Arm Description

Omentectomy during cancer gastric surgery

Arm Title

Omental preservation

Arm Type

Other

Arm Description

Preserval omentation during cancer gastric surgery

Intervention Type

Other

Intervention Name(s)

Surgery procedure

Other Intervention Name(s)

Omentectomy, Omental preservation

Intervention Description

Omentectomy vs omental preservations during gastric surgery

Primary Outcome Measure Information:

Title

disease free interval

Description

time between surgery and recurrence. Units of measure: months

Time Frame

5 years

Secondary Outcome Measure Information:

Title

global survival

Description

survival between surgery and last follow-up date. Units of measure: percentage

Time Frame

5 years

Title

survival at 5 years

Description

survival between surgery and 5 years. Units of measure: percentage

Time Frame

5 years

Title

complications - CCI

Description

type of complications and CCI number. Units of measure: enter number between 1 and 100

Time Frame

30 days after surgery

Title

postoperatory mortality

Description

mortality after surgery. Units of measure: percentage

Time Frame

30 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sandra Montmany, PhD

Phone

937231010

Ext

21490

smontmany@tauli.cat

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea Torrecilla, MD

Phone

937231010

Ext

21490

atorrecillaportoles@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

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Omentectomy vs Omental Preservation in Resectable Cancer

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