None listed
Conditions
Interventions
Procedure/Surgery : Gastrectomy or endoscopic submucosal dissection
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are diagnosed with undifferentiated type EGC (signet ring cell carcinoma, poorly differentiated tubular adenocarcinoma, or poorly cohesive carcinoma) that meets the expanded indication of ESD 1) Tumor confined to the mucosa without ulcer, and size =2 cm on endoscopic evaluations 2) No evidence of lymph node metastasis and distant metastasis on abdominal CT scan 2. Adult patients aged 19-75 years 3. Patients who had willingness to sign an informed consent form
Exclusion criteria
Exclusion criteria: 1. Patient age: 75 years 2. Diagnosis and active treatment for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years 3. Previous gastrectomy or esophagectomy history 4. Multiple gastric cancers 5. Current treatment for serious medical condition which could hinder study participation including severe heart dysfunction, liver cirrhosis, renal failure, chronic obstructive pulmonary disease or asthma, or uncontrolled infection 6. Inability to provide an informed consent 7. Inadequate conditions for study enrollment according to the evaluation of study physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival in the ITT population | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival in the PP population ;Overall survival;Curative resection rate of ESD;Quality of life changes during follow-up periods;Treatment related complications (adverse events);Cost-effectiveness of treatments | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-Il Kim
National Cancer Center
Outcome results
None listed