Exploration of Lymph Node Metastasis and Tumor Deposit in the Posterior Gastric Mesentery for Distal Gastric Cancer

NCT ID: NCT06736847

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate lymph node metastasis and tumor deposit in the posterior gastric mesentery following distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Since 1997, the AJCC has been using the number of lymph node metastases (pN staging) as a crucial indicator to assess the prognosis of gastric cancer patients. This system has been continuously updated, widely accepted by the global oncology community, and confirmed for its feasibility, applicability, convenience, and reproducibility. The number of metastatic lymph nodes in radical resection specimens of gastric cancer patients is the total count of lymph nodes with metastasis and is a key focus of postoperative pathological examination. D2 lymphadenectomy has become the standard operative procedure for advanced resectable gastric cancer and certain early-stage gastric cancers (diagnosed preoperatively with lymph node metastases). For advanced gastric cancer, there is growing evidence that the ideal surgical approach should involve D2 lymphadenectomy plus CME. In distal gastrectomy, the number of lymph nodes removed in D2 lymphadenectomy plus CME is significantly higher than in D2 dissection. Additionally, patients in the D2+CME group exhibit better long-term outcomes compared to the D2 group (DCGC01 study). Performing D2+CME surgery for distal gastric cancer involves the resection of the five major mesentery, including the posterior gastric mesentery, which may aid in thorough lymph node clearance and reduce cancer spillage. The posterior gastric mesentery comprises the No.11p and part of the No.11d lymph nodes. However, only the No.11p lymph nodes are resected in traditional D2 lymphadenectomy, resulting in incomplete lymph node clearance and postoperative tumor recurrence. Hence, the primary objective of this study is to examine lymph node metastasis in the posterior gastric mesentery following D2+CME in patients undergoing distal gastrectomy, aiming to offer evidence-based medical insights for standardizing surgical approaches in gastric cancer management.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radical gastrectomy with membrane dissection

distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer

Intervention Type PROCEDURE

distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer

distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged older than 18 years and younger than 85 years
2. Primary gastric adenocarcinoma confirmed by preoperative pathology result
3. cT2-4N0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 7th Edition
4. Patients who received distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision
5. American Society of Anesthesiologists (ASA) class I, II, or III
6. Written informed consent

Exclusion Criteria

1. Negative preoperative biopsy
2. Too late tumour stage or metastasis (cT4b/M1)
3. BMI\>30 kg/m2
4. Total gastrectomy or proximal gastrectomy
5. previous neoadjuvant chemotherapy or radiotherapy
6. Previous upper abdominal surgery
7. Combined with other malignant diseases
8. Reject operation
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jichao Qin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jichao Qin

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tao Wang, Ph.d

Role: CONTACT

+86-197-068-25286

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tao Wang, Ph.d

Role: primary

+86-197-068-25286

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-0899

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.