Expanded Indications of Endoscopic Submucosal Dissection for Early Gastric Cancer in China

Expanded Indications of Endoscopic Submucosal Dissection for Early Gastric Cancer in China: a Multicenter, Ambispective, Observational, Open-cohort Study

Background: The main treatment methods for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications for ESD remains unestablished. In China, evidence-based medicine for the expanding indications of ESD and accurate diagnostic staging for EGC patients are lacking. Thus, clinical studies involving Chinese patients with EGC are necessary to select appropriate treatment options and promote China's expanded indications for ESD and diagnostic staging scheme.

Methods: This is a multicenter, ambispective, observational, open-cohort study that is expected to enroll 554 patients with EGC. The study was launched in May 2018 and is scheduled to end in March 2022. All enrolled patients should meet the inclusion criteria. Case report forms and electronic data capture systems are used to obtain clinical data, which includes demographic information, results of perioperative blood- and auxiliary examinations, surgical information, results of postoperative pathology, and the outcomes of postoperative recovery and follow-up. Patients are followed up every 6 months after surgery for a minimum of 5 years. The primary endpoint is the rate of lymph node metastasis (LNM), whereas the secondary endpoints include the following: consistency, sensitivity, and specificity of the results of preoperative examinations and postoperative pathology cut off values for LNM; logistic regression model of expanded indications for ESD; and incidence of postoperative complications within the 30-day and 5-year relapse-free survival rates.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer Stage
• Intervention / Treatment: Procedure: D2 gastrectomy

Detailed Description

This study will explore and evaluate expanded indications for ESD that match the characteristics of the Chinese population in patients with EGC and will introduce a related staging procedure and examination scheme that is appropriate for China. Ethical approval was obtained from all participating centers. The findings are expected to be disseminated through publications or presentations and will facilitate clinical decision-making in EGC.

• Study Type: Observational
• Enrollment (Actual): 1291

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

This study aims to explore and evaluate expanded indications for ESD that match the characteristics of the Chinese population in patients with EGC, and to introduce a staging procedure and examination scheme for EGC that is appropriate for China.

Description

Inclusion Criteria:

Patients aged 18-75 years (regardless of sex). Patients with tumor diameter > 30 mm, ulceration (UL)(+), and differentiated mucosal carcinoma (T1a).

Patients with tumor diameter > 30 mm and differentiated, submucosal invasion depth < 500 μm (T1b SM1).

Patients with tumor diameter ≤ 30 mm and differentiated submucosal carcinoma (T1b).

Patients with tumor diameter ≤ 20 mm, UL(-), and undifferentiated (T1a). Patients with tumor diameter > 20 mm, UL(-), and undifferentiated (T1a). Patients with tumor diameter ≤ 30 mm, UL(+), and undifferentiated (T1a). Patients with tumor diameter > 30 mm, UL(+), and undifferentiated (T1a).

Exclusion Criteria:

Patients with gastric stump cancer. Patients with recurrent gastric cancer. Patients with multiple primary malignant tumors.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
D2 gastrectomy; Under the requirement of the guideline for laparoscopic gastrectomy for gastric cancer (2016 edition), laparoscopic radical gastrectomy is performed in patients.	Procedure: D2 gastrectomy; Under the requirement of the guideline for laparoscopic gastrectomy for gastric cancer (2016 edition), laparoscopic radical gastrectomy is performed in patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of lymph node metastasis	periprocedurally

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy, specificity, and sensitivity of gold standards	Postoperative histopathology of ultrasonic gastroscopy for tumor invasion depth, abdominal and pelvic enhanced computed tomography (CT) scan for LNM, pathological biopsy for tumor differentiation, and auxiliary examination for TNM staging.	through study completion, an average of 5 year
Logistic regression model	To explore the corresponding logistic regression model, postoperative histopathological examination for LNM, depth of infiltration, and degree of differentiation are evaluated in the univariate analysis. Variables with statistical significance in the univariate analysis are examined in the multivariate analysis.	Periprocedural
Complications	Postoperative complications classified as higher than Grade II	Periprocedural
Five-year relapse-free survival rate	The time interval from the date of operation to the detection of tumor recurrence within 5 years is recorded.	through study completion, an average of 5 year

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 11, 2025

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Lymph node metastasis; Chinese population; Expanded indications for ESD; Staging diagnosis scheme
• 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: ChiCTR1800016084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No