D2＋CME in Gastric Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Gastric Cancer

Intervention / Treatment

Procedure: D2＋CME

Detailed Description

Previous studies have established the existence of the mesogastrium, dividing it into six sections. The mesogastrium is identified during surgery and utilized in surgical practice. The aim of the present study was to further investigate its role in gastric cancer prognosis.Between January 2014 and January 2018, patients from the Tongji Hospital were included in this post-hoc analysis, including data from a randomized clinical study (DCGC01; http://www.clinicaltrials.gov, NCT01978444). Mesogastria containing metastatic lymph nodes (LNs) were referred to as metastatic mesogastria. Pathology reports were examined to assess metastases in the mesogastrium. Survival was assessed using Kaplan-Meier curves and multivariable Cox models.

Study Type

Observational

Enrollment (Actual)

480

Contacts and Locations

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

Study Locations

China
- Hubei
  - Wuhan, Hubei, China, 430000
    - Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

Non-Probability Sample

Study Population

Patients with gastric cancer who underwent total or proximal gastrectomy in Tongji Hospital were included in this study

Description

Inclusion Criteria:

older than 18, younger than 85
primary gastric adenocarcinoma confirmed by preoperative pathology
routine blood tests, liver and kidney functions and who health status score are within the range of tolerable surgery
it is expected to perform radical gastrectomy through d2+cme

Exclusion Criteria:

pregnant or lactating women
severe mental disorder or language communication disorder
preoperative imaging examination or intraoperative exploration found that the patient had the following conditions: tumor involving surrounding organs requiring combined organ resection, distant organ metastasis or R0 resection could not be achieved
those who are not suitable for laparoscopic surgery (such as extensive adhesion caused by anterior abdominal surgery and pneumoperitoneum for various reasons).
concurrent malignancies at other sites
emergency surgery patients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival Time Frame: Postoperative 5-year survival	Postoperative 5-year survival	Postoperative 5-year survival

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Mesogastria Containing Metastatic Lymph Nodes Time Frame: Postoperative 5-year	The Number of Mesogastria Containing Metastatic Lymph Nodes	Postoperative 5-year

Collaborators and Investigators

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

Sponsor

Jichao Qin

Investigators

Principal Investigator: Jichao Qin, M.D./Ph.D, Huazhong University of Science and Technology

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)

May 1, 2020

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria