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

NCT06869356 | Completed DMC

• 1 other identifier: ChiCTR1800016084
• Study Type: observational
• Target: 1,291
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer Stage

Keywords

Expanded indications for ESD; Lymph node metastasis; Staging diagnosis scheme; Chinese population

Outcome Measures

Primary Outcomes (1)

• Rate of lymph node metastasis

  periprocedurally

Secondary Outcomes (4)

• Accuracy, specificity, and sensitivity of gold standards

  through study completion, an average of 5 year

• Logistic regression model

  Periprocedural

• Complications

  Periprocedural

• Five-year relapse-free survival rate

  through study completion, an average of 5 year

Study Arms (1)

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

Interventions

D2 gastrectomy PROCEDURE

Under the requirement of the guideline for laparoscopic gastrectomy for gastric cancer (2016 edition), laparoscopic radical gastrectomy is performed in patients.

D2 gastrectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: March 11, 2025
• Study Start: May 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: January 11, 2025
• Last Updated: March 11, 2025

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)