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NCT Number: NCT06736847

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

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Tao Wang, Ph.d

CONTACT

[email protected]

+86-197-068-25286

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. Rate of lymph node metastasis and tumor deposit in the posterior gastric mesentery

    Time frame: through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Wang, Ph.d

CONTACT

[email protected]

+86-197-068-25286

Sponsors and collaborators

Lead sponsor

Jichao Qin

Other

Registry information

Official study 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

Acronym: zydgc001

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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