Prediction Model of Occult Omental Metastasis in Patients With Gastric Cancer

May 5, 2024 updated by: Daorong Wang, Northern Jiangsu People's Hospital

A Nomogram for Predicting Occult Omental Metastasis in Patients With Gastric Cancer

A complete omentectomy is typically recommended during radical total gastrectomy for gastric cancer, though its impact on survival remains unclear. This study aimed to assess the frequency and risk factors of metastases in the greater omentum in gastric cancer patients undergoing gastrectomy. It will involve a single prospective cohort of consecutive patients who underwent total gastrectomy with complete en bloc omentectomy and modified D2 lymphadenectomy. Post-surgery, the omentum will dissect from the gastrectomy specimen beyond the gastroepiploic vessels and examine separately for pathological assessment. The primary outcome will focus on the detection of omental metastases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

It included consecutive patients with a primary gastric adenocarcinoma (cT1-4N0-3M0) in whom a potentially curative total gastrectomy could be performed.

Description

Inclusion Criteria:

  1. pathological confirmation of gastric cancer
  2. eligibility for surgical intervention
  3. undergoing first rectal cancer surgery
  4. acquisition of written informed consent from patients and their families
  5. no history of hypertrophic scar or allergic predispositions

Exclusion Criteria:

  1. absence of postoperative pathology of the omentum
  2. diagnosis of multiple primary malignancies
  3. intraoperative discovery of widespread implant metastases within the abdominal cavity
  4. severe comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with omental metastases
Other: Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors
Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors
patients without omental metastases
Other: Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors
Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients with omental metastases
Time Frame: up to 2 weeks after gastric cancer surgery
After the operation, the postoperative pathological examination of the patient indicated the presence of omental metastases
up to 2 weeks after gastric cancer surgery
patients without omental metastases
Time Frame: up to 2 weeks after gastric cancer surgery
After surgery, pathological examination confirmed no omental metastases
up to 2 weeks after gastric cancer surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Jiangsu People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

May 5, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 5, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NorthernJiangsu003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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