Clinical trial NCT06869356: Expanded Indications of Endoscopic Submucosal Dissection for Early Gastric Cancer in China
Official title: Expanded Indications of Endoscopic Submucosal Dissection for Early Gastric Cancer in China: a Multicenter, Ambispective, Observational, Open-cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer Stage
Keywords: Expanded indications for ESD
Lymph node metastasis
Staging diagnosis scheme
Chinese population
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 1291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of lymph node metastasis
timeFrame: periprocedurally
Secondary outcomes:
measure: Accuracy, specificity, and sensitivity of gold standards
timeFrame: through study completion, an average of 5 year
measure: Logistic regression model
timeFrame: Periprocedural
measure: Complications
timeFrame: Periprocedural
measure: Five-year relapse-free survival rate
timeFrame: through study completion, an average of 5 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship hospital
state: Beijing
Study officials:
References: