Safety and Effectiveness of ESD combined with laparoscopic sentinel lymph node dissection in the treatment of early gastric cancer with ESD expansion indications

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100048348

Enrollment

Unknown

Registered

2021-07-06

Start date

2021-06-30

Completion date

Unknown

Last updated

2025-09-29

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

Conditions

early gastric cancer

Interventions

Experimental group:ESD+laparoscopic sentinel lymph node dissection

Control group:Surgery

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.According to the comprehensive evaluation of the General Surgery Oncology, pathology and other multidisciplinary experts, gastrectomy can not be accepted; 2.Aged 18 to 80 years; 3.CT1N0M0 early gastric cancer conforming to ESD expanded indications: (1)cT1a, UL (-), undifferentiated type, > 20mm; (2)CT1a, UL (+), undifferentiated type; (3)CT1a, UL (+), differentiated, > 30mm; (4)cT1b; 4.Postoperative pathology of ESD is CT1N0M0 early gastric cancer with expanded indications of ESD; 5.Signed informed consent; 6.Patients can receive regular follow-up.

Exclusion criteria

Exclusion criteria: 1.Preoperative examination showed that the disease was stage II / III / IV; 2.Preoperative examination showed enlargement of perigastric or retroperitoneal lymph nodes; 3.Severe diseases of other organs; 4.Patients with a history of gastric surgery; 5.Patients with ASA grade anesthesia contraindication; 6.Patients with bleeding tendency; 7.Pregnant or lactating women; 8.Allergic to tracer; 9.No follow-up treatment due to other reasons.

Design outcomes

Primary

Measure	Time frame
Disease specific survival rate;	—

Secondary

Measure	Time frame
mortality;Overall survival rate;Recurrence rate;Lymph node metastasis rate;Incidence of metachronous gastric cancer;	—

Countries

China

Contacts

Public ContactChai Ningli

Chinese PLA General Hospital

chainingli@vip.163.com+86 15011362982

Outcome results

None listed

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