- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06728878
Analysis of Lymph Node Metastasis and Tumor Deposit in the Short Gastric Mesentery Following Total Gastrectomy for Gastric Cancer (zytg001)
August 25, 2025 updated by: Jichao Qin
Lymph Node Metastasis and Tumor Deposit in the Short Gastric Mesentery Following Total Gastrectomy With D2 Lymphadenectomy Plus Complete Mesogastric Excision for Gastric Cancer: A Prospective Observational Study
This study aims to explore lymph node metastasis in the short gastric mesentery following total gastrectomy with D2 lymphadenectomy plus complete mesogastric excision, providing evidence-based medicine for standardizing lymph node dissection in gastric cancer.
Study Overview
Status
Recruiting
Conditions
Detailed Description
According to the 6th edition of the Japanese Gastric Cancer Treatment Guidelines; total gastrectomy with D2 lymphadenectomy includes groups No.1 to No.7, No.8a, No.9, No.11p, No.11d, and No.12a.
The No.4sa group lymph nodes are defined as the lymph nodes along the short gastric vessel, No.10 group lymph nodes are defined as the lymph nodes at the splenic hilum including the lymph nodes at the roots of the short gastric arteries.
In routine total gastrectomy with D2 combined with CME surgery, the standard practice involves resection of the short gastric mesentery (No.4sa group and No. 10 group).
There are typically 3-4 short gastric arteries in the human body, further investigation is required to determine the lymph node metastasis rates in each short gastric mesentery.
Patients undergoing total gastrectomy with D2 combined with CME will have their short gastric mesenteries anatomically separated for examination, and this aims to analyze the positive rate of lymph nodes in the short gastric mesentery and investigate the correlation between tumor location, staging, and lymph node metastasis in the short gastric mesentery.
Study Type
Observational
Enrollment (Estimated)
150
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
- Name: Tao Wang, Ph.D
- Phone Number: +86-197-068-25286
- Email: 15002740874@163.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine
-
Contact:
- Tao Wang, Ph.D
- Phone Number: +86-197-068-25286
- Email: 15002740874@163.com
-
-
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 who received total gastrectomy with D2 lymphadenectomy plus complete mesogastric excision.
At the same time, the patients met the above inclusion and exclusion criteria.
Description
Inclusion Criteria:
- Aged older than 18 years and younger than 85 years
- Primary gastric adenocarcinoma confirmed by preoperative pathology result
- cT2-4aN0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- Patients who received total gastrectomy with D2 lymphadenectomy plus complete mesogastric excision
- American Society of Anesthesiologists (ASA) class I, II, or III
- Written informed consent
Exclusion Criteria:
- Negative preoperative biopsy
- Too late tumour stage or metastasis (cT4b/M1)
- BMI>30 kg/m2
- previous neoadjuvant chemotherapy or radiotherapy
- Previous upper abdominal surgery
- Combined with other malignant diseases
- Reject operation
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 |
|---|
|
Patients who received total gastrectomy with D2 lymphadenectomy plus complete mesogastric excision
No additional intervention is imposed on patients except normal clinical diagnosis and treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of lymph node metastasis and tumor deposit in the short gastric mesentery
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
September 1, 2024
First Submitted That Met QC Criteria
December 8, 2024
First Posted (Actual)
December 11, 2024
Study Record Updates
Last Update Posted (Estimated)
September 2, 2025
Last Update Submitted That Met QC Criteria
August 25, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0899-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.