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Recruiting NCT06736847

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

Observational Gastric Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer.
Who it may be relevant to
Registry conditions: Gastric Carcinoma. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Exploration of Lymph Node Metastasis and Tumor Deposit in the Posterior Gastric Mesentery Following D2 Lymphadenectomy Plus Complete Mesogastric Excision in Patients Who Received Distal Gastrectomy: A Prospective Observational Study

Overview

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

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.

Interventions

  • Procedure 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

Primary outcome measures

  • Rate of lymph node metastasis and tumor deposit in the posterior gastric mesentery [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Aged older than 18 years and younger than 85 years
  • Primary gastric adenocarcinoma confirmed by preoperative pathology result
  • cT2-4N0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 7th Edition
  • Patients who received distal 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
  • Total gastrectomy or proximal gastrectomy
  • previous neoadjuvant chemotherapy or radiotherapy
  • Previous upper abdominal surgery
  • Combined with other malignant diseases
  • Reject operation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University — Hangzhou

Identifiers

NCT: NCT06736847 · 2024-0899

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗