Overview
To evaluate the safety of robot-assisted radical gastrectomy with D2 lymph node dissection in postoperative complications in patients with neoadjuvant chemotherapy for gastric cancer (cT3-4a, N+, M0).
Eligibility
Inclusion Criteria:
Age from over 18 to under 75 years; Primary gastric adenocarcinoma (including pap, tub,
muc, sig, and por) confirmed pathologically by endoscopic biopsy; cT3-4a, N-/+, M0
according to the AJCC 8th Cancer Staging Manual; Without peritoneal metastasis (examined by
laparoscopic examination); Radical resection (R0) through distal subtotal gastrectomy with
D2 lymphadenectomy is anticipated; Performance status 0 or 1 (Eastern Cooperative Oncology
Group) ; ASA (American Society of Anesthesiology) score ≤ 3;
Normal hemodynamic indices:
Blood cell count: HB ≥ 90g/L, ANC ≥ 1.5×109/L, PLT ≥ 80×109/L; Liver and renal function:
BIL<1.5 times of the upper limit of normal reference values, ALT and AST<2.5 times of the
upper limit of normal reference values, and Crea≤1 time of upper limits of normal reference
values.
Therapeutic response rating after neoadjuvant chemotherapy is CR, PR, SD, or Therapeutic
response rating after neoadjuvant chemotherapy is PD, tumor is expected to have radical
resection; Subjects are still willing to continue participating in this clinical trial.
Exclusion Criteria:
History of upper abdominal surgery (include endoscopic mucosal resection or endoscopic
submucosal dissection, except for laparoscopic cholecystectomy); History of acute
pancreatitis; Enlarged or bulky regional lymph node (diameter>3cm) by imaging exam;
Patients have received neoadjuvant therapy prior to screen work; History of other malignant
disease within the past five years; History of cerebrovascular accident within the past six
months; History of continuous systematic administration of corticosteroids within the past
month; Scheduled simultaneous surgery for other disease; Emergency surgery due to
complication (bleeding, obstruction or perforation) caused by gastric cancer; Pyloric
obstruction; FEV1<50% of predicted value; Women who are pregnant or lactating at the time
of screening; Severe mental disorder; Participating in other clinical studies; Refused to
sign the informed consent;
Therapeutic response rating after neoadjuvant chemotherapy is PD, involvement of adjacent
structures(T4b), distal metastasis(M1), or enlarged or bulky regional lymph node
(diameter>3cm) by preoperative imaging Patients cannot complete 3 cycles of chemotherapy
due to intolerance; After 3 cycles of neoadjuvant chemotherapy, patients cannot tolerate
surgery due to severe adverse reactions, or ASA score ≥ 4 ; Patients undertake emergency
operation due to tumor bleeding, perforation or obstruction during chemotherapy; After
signing the informed consent, the patient withdraws from this clinical trial.