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NCT Number: NCT06934824

Clinical Study of Double-Endoscopic Combined With Minimally Invasive Treatment for Early Gastric Cancer at Clinical Stage T1b

For patients diagnosed with early gastric cancer involving submucosal invasion, super-ESD indications, or lymph node metastasis, a combination of preoperative endoscopic ultrasound and abdominal contrast-enhanced CT was utilized to ascertain the depth of tumor invasion and to identify any suspicious metastatic lymph nodes in the vicinity of the stomach. Subsequently, a local full-thickness resection, coupled with or followed by individualized precise lymph node dissection, was conducted to fulfill the following objectives: ① To investigate the safety, feasibility, and efficacy of local resection for patients meeting super-ESD criteria; ② To offer a clinical foundation for the individualized and precise lymph node dissection treatment of early gastric cancer.

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Key information

Conditions

Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-70 years old;
  • Endoscopic pathological diagnosis: adenocarcinoma;
  • Enhanced abdominal CT combined with endoscopic ultrasound clinical staging: T1bN0-1M0.
  • Has not received other treatment;
  • No other serious comorbidities;
  • Agree to participate in the study and sign the informed consent form.

Exclusion criteria

  • Pregnant or breastfeeding women
  • History of previous abdominal surgery
  • History of other previous malignancies
  • Can patients with severe heart, lung, brain diseases tolerate surgical treatment

Treatment and study plan

Sixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und

Procedure

Patients in group A-No lymph node metastasis, who underwent simple Double-Endoscopic Combined with local full-thickness resection.

Patients in group B-imaging examination showed lymph node metastasis. patients were randomly divided into Group N + a and Group N + b.

Group N + a: Local full-thickness gastric wall and lymph nodes dissection on D1 or D1 + were performed with Double-Endoscopic Group N + b: Traditional standard surgical gastrectomy and D1 or D1 + lymph nodes dissection was performed .

Primary outcomes

  1. Rate of recurrence

    Time frame: Within 2 years

Secondary outcomes

  1. The operation time, complications and hospital stay were recorded

    Time frame: 30 days

Study contacts

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

Gang pei Yang, Master's degree

CONTACT

China+8613731153070

Qun Zhao, Ph.D

CONTACT

[email protected]

China+8613930162111

Sponsors and collaborators

Lead sponsor

Hebei Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 18, 2025
Registry last updated
Apr 18, 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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