None listed
Conditions
Interventions
Procedure/Surgery : 1) Preoperative Details
All participants will undergo minimally invasive distal gastrectomy and lymphadenectomy. The only difference between the control and experimental groups is
the rest of the procedures are identical.
Patients may or may not have a nasogastric tube inserted.
Prophylactic antibiotics (1st or 2nd generation cephalosporins) will be administered within 30 minut
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 20 to 85 years who were diagnosed with gastric adenocarcinoma through endoscopic biopsy. 2) Patients with an ECOG performance status of 0 or 1 and an ASA classification of I-III. 3) Patients with Borrmann type I, II, or III lesions observed during endoscopy. 4) Patients with lesions located in the middle or lower part of the stomach, eligible for distal gastrectomy. 5) Patients diagnosed with locally advanced gastric cancer (cT3-T4a), where serosal invasion is suspected through preoperative or intraoperative tests, and who have no lymph node metastasis or limited lymph node involvement to the adjacent gastric region (N0/+), as per AJCC 8th edition staging (cT3N0M0 to cT4aN3M0). 6) Patients for whom preoperative assessments indicate that minimally invasive (laparoscopic or robotic) curative gastrectomy is feasible. 7) Patients who have voluntarily consented to participate in the clinical study after receiving a full explanation of the study's purpose and details, and have signed an informed consent form approved by the institutional review board. 8) Patients who are residents of the country and available for follow-up for 3 years after surgery.
Exclusion criteria
Exclusion criteria: 1) Patients with confirmed distant metastasis through preoperative tests. 2) Patients with metastasis to the peritoneum, liver, or other abdominal organs observed during surgery. 3) Patients with a history of previous gastric surgery or surgery related to the omentum. 4) Patients who have received preoperative chemotherapy, radiation therapy, or endoscopic submucosal dissection for the current diagnosed gastric cancer. 5) Patients who have undergone surgery, chemotherapy, or radiation therapy for primary cancers of other organs within the past 5 years. 6) Patients with active synchronous multiple cancers. 7) Vulnerable participants (those lacking decision-making capacity, pregnant women, or women planning to become pregnant). 8) Patients currently participating in another interventional clinical trial. 9) Patients who withdraw consent to participate in the clinical study after randomization. 10) Patients who have not undergone surgery within 30 days after consenting to participate in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival;3-year peritoneal metastasis rate;Operation time, blood loss;Postoperative complications (early complications within 30 days, late complications thereafter);Mortality rate within 90 days post-surgery | — |
Countries
Korea, Republic of
Contacts
Public ContactINGYU KWON
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed