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Safety and efficacy study of endoscopic submucosal dissection (ESD) combined with sentinel lymph node dissection in the treatment of patients with T1b gastric cancer

Safety and efficacy study of endoscopic submucosal dissection (ESD) combined with sentinel lymph node dissection in the treatment of patients with T1b gastric cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105543
Enrollment
Unknown
Registered
2025-07-07
Start date
2025-04-23
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

SLNB group:Patients with early-stage gastric cancer who are evaluated by gastroscopy and endoscopic ultrasound before surgery should undergo sentinel lymph node dissection at the same time as ESD in t
If positive, standard radical gastrectomy is added. Patients with pathological diagnosis of off-label after ESD surgery underwent sentinel lymph node dissection within 1 month after ESD
If sentinel lymph nodes are negative, no further lymph node dissection is required
If positive, standard radical gastrectomy is added.
control group:Radical gastrectomy is performed directly for off-label early-stage gastric cancer.

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age>=18 years; 2. Endoscopic or/and pathological diagnosis of early gastric cancer (T1b) beyond ESD indications; 3. Preoperative imaging examinations (such as endoscopic ultrasound, CT, etc.) showed no distant metastases, and the clinical stage was cN0; or by multidisciplinary collaboration (MDT) to discuss the tendency of enlarged lymph nodes around the stomach to be non-metastatic lymph nodes; 4. Patient's informed consent.

Exclusion criteria

Exclusion criteria: 1.History of previous gastric cancer, neoadjuvant therapy or adjuvant therapy; 2. The depth of the lesion exceeds the submucosa; 3. Lymph node metastases or distant metastases on imaging examination; 4.History of other malignant tumors and anti-tumor therapy; 5.Inability to tolerate surgery or presence of contraindications to surgery; 6. Patient does not consent to sentinel lymph node dissection.

Design outcomes

Primary

MeasureTime frame
3-year disease free survival;

Secondary

MeasureTime frame
5-year disease free survival;

Countries

China

Contacts

Public ContactRong long

Peking University First Hospital

dr_rlnjzx@126.com+86 83572437

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026