Gastric cancer
Conditions
Interventions
Test Group:Laparoscopic distal gastrectomy with D2 lymphadenectomy after neoadjuvant chemotherapy
Control Group:Open distal gastrectomy with D2 lymphadenectomy after neoadjuvant chemotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years. 2.Primary gastric lesion histologically confirmed as gastric adenocarcinoma by endoscopic biopsy, including papillary adenocarcinoma (pap), tubular adenocarcinoma (tub), mucinous adenocarcinoma (muc), signet-ring cell carcinoma (sig), or poorly differentiated adenocarcinoma (por). 3.Tumor located in the middle or lower third of the stomach, with preoperative evaluation indicating feasibility of distal gastrectomy. 4.Clinical stage before neoadjuvant chemotherapy: cT3–4a, N-/+, M0. 5.Diagnostic staging laparoscopy prior to neoadjuvant chemotherapy is not mandatory. 6.Completion of standard preoperative neoadjuvant chemotherapy, with regimens recommended by guidelines: three cycles of XELOX, three cycles of SOX, four cycles of FLOT4, or three cycles of DOS. 7.Interval between completion of neoadjuvant chemotherapy and surgery: 4–6 weeks. 8.Post-chemotherapy staging: T stage = 90 g/L; neutrophils >= 1.5 × 10^9/L; platelets >= 80 × 10^9/L. 2) Serum biochemistry: total bilirubin < 1.5 × upper limit of normal (ULN); ALT and AST < 2.5 × ULN; serum creatinine <= 1 × ULN. 13.Willingness to participate in this clinical trial and provision of informed consent.
Exclusion criteria
Exclusion criteria: 1.History of previous upper abdominal surgery, except for laparoscopic cholecystectomy. 2.History of endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) for gastric cancer. 3.History of acute pancreatitis. 4.Preoperative assessment indicating the need for total gastrectomy. 5.Radiological evidence of regional conglomerated lymph nodes (maximum diameter > 3 cm) prior to neoadjuvant chemotherapy. 6.Radiological evidence of regional conglomerated lymph nodes (maximum diameter > 3 cm) after neoadjuvant chemotherapy. 7.History of other malignancies within the past 5 years. 8.History of unstable angina, myocardial infarction, cerebral infarction, or intracerebral hemorrhage within the past 6 months. 9.History of continuous systemic corticosteroid therapy within the past 1 month. 10.Requirement for concomitant surgical procedures for other diseases (except cholecystectomy). 11.Emergency surgery required for gastric cancer–related complications (e.g., bleeding, perforation). 12.Presence of gastric outlet obstruction. 13.Pulmonary function test showing predicted FEV1/FVC < 50%. 14.Pregnant or breastfeeding women. 15.Presence of severe psychiatric disorders. 16.Withdrawal of consent after signing informed consent for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-Year Disease-Free Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-Year Overall Survival Rate;5-Year Overall Survival Rate; | — |
Countries
China
Contacts
Public ContactHu Jiankun
West China Hospital, Sichuan University
Outcome results
None listed