NCT06869356Completed
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
Source: ClinicalTrials.gov · Last updated 11 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1291 (actual)
- First submitted
- 21 Jan 2025
- Start date
- 1 May 2018
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Beijing Friendship Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06869356
What you commit to
- Study type: Observational
- Participants enrolled: 1291
- From 1 May 2018 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with gastric stump cancer. Patients with recurrent gastric cancer. Patients with multiple primary malignant tumors.
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.