NCT06697821

Brief Summary

To investigate the impact of the number of mesogastria containing metastatic lymph nodes on the prognosis of gastric cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

November 18, 2024

Last Update Submit

November 20, 2024

Conditions

Keywords

metastasisGastric CancerLymph nodeMesogastrium

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Postoperative 5-year survival

    Postoperative 5-year survival

Secondary Outcomes (1)

  • The Number of Mesogastria Containing Metastatic Lymph Nodes

    Postoperative 5-year

Interventions

D2+CMEPROCEDURE

Whether to perform the whole mesogastric excision

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jichao Qin, M.D./Ph.D

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 20, 2024

Study Start

May 1, 2020

Primary Completion

May 1, 2023

Study Completion

May 1, 2024

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations