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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy
• Intervention / Treatment: Procedure: 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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qun Zhao, Ph.D; Phone Number: China+8613930162111; Email: zhaoqun@hebmu.edu.cn
• Study Contact Backup: Name: Gang pei Yang, Master's degree; Phone Number: China+8613731153070

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. History of previous abdominal surgery
3. History of other previous malignancies
4. Can patients with severe heart, lung, brain diseases tolerate surgical treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients in group A-No lymph node metastasis, who underwent simple Double-Endoscopic Combined with local full-thickness resection.	Procedure: 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; 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 .
Experimental: Group B; 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 .	Procedure: 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; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of recurrence	Within 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The operation time, complications and hospital stay were recorded	30 days

Collaborators and Investigators

• Sponsor: Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 9, 2025
• First Submitted That Met QC Criteria: April 12, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 12, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: FUTURE11

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