None listed
Conditions
Interventions
Procedure/Surgery : Randomization at enrollment will be conducted on a 1:1 basis for each investigator.
Baseline numbers (BN) will be assigned to participants in the order in which informed consent is
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 to 85 years with early gastric cancer (cT1N0). 2. Patients with cT1 and cN0 stage as confirmed by CT, endoscopy, and endoscopic ultrasound, with no evidence of distant metastasis. AJCC 8th edition, cT1N0M0. 3. Patients with an ECOG performance status of 0 or 1 and an ASA score of class I to III according to the American Society of Anesthesiologists. 4. Patients whose lesions are not located in the upper part of the stomach, making subtotal gastrectomy possible. 5. Patients for whom a minimally invasive (laparoscopic or reduced-port robotic) curative gastrectomy is deemed feasible based on preoperative evaluations. 6. Patients who have signed a written informed consent form after receiving adequate explanation of the study’s purpose and content, and who have been approved by the institutional review board (IRB). 7. Patients who are residents of Korea and able to undergo follow-up for 3 years post-surgery.
Exclusion criteria
Exclusion criteria: 1. Patients who are diagnosed with advanced gastric cancer, not early gastric cancer, based on preoperative gastroscopy or CT scan. 2. Patients with confirmed distant metastasis on preoperative examinations. 3. Patients with a history of previous gastrectomy. 4. Patients with active malignancies diagnosed within the last 5 years, who are undergoing treatment or follow-up. 5. Patients currently participating in another interventional clinical study. 6. Vulnerable subjects (those with impaired decision-making capacity, pregnant women, or women planning to become pregnant). 7. Patients who withdraw their consent to participate in the clinical study after randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of Clavien–Dindo grade III or higher postoperative complications occurring within 30 days after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative complications (both early complications within 30 days and late complications thereafter) ;Postoperative mortality (all-cause mortality within 90 days after surgery) ;Length of postoperative hospital stay;Postoperative quality of life (QOL) assessments at 30 days, 6 months, and 1 year, including dietary function and wound satisfaction ;Standard surgical outcomes (resection margins, number of harvested lymph nodes, rate of readmission, etc.) ;Three-year disease-free survival and overall survival rat | — |
Countries
Korea, Republic of
Contacts
Public ContactSung Hyun Park
Yonsei University Health System, Severance Hospital
Outcome results
None listed