Gastric cancer
Conditions
Interventions
Control group:ICG is injected intravenously during the operation
Experimental Group:ICG is injected into the submucosa endoscopically before surgery
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years; 2.Pathologically proven gastric adenocarcinoma; 3.Clinical stage T1-4a, N0/+, M0 according to the 8th edition of American Joint Committee on Cancer (AJCC) TNM classification; 4.Scheduled for distal gastrectomy with D1+/D2 lymphadenectomy, and possible for R0 surgery by this procedure; 5.Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG); 6.American Society of Anesthesiology score (ASA) class I, II, or III; 7.Written informed consent;
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; 2.Suffering from severe mental disorders; 3.History of upper abdominal surgery; 4.History of gastric surgery; 5.Preoperative imaging examination indicates regional fused and enlarged lymph nodes; 6.History of other malignant diseases within 5 years; 7.Has undergone neoadjuvant therapy; 8.History of unstable angina or myocardial infarction within 6 months; 9.History of cerebral infarction or cerebral hemorrhage within 6 months; 10.History of continuous systemic corticosteroid treatment within 1 month; 11.Need for concurrent surgical treatment of other diseases; 12.Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery; 13.Pulmonary function test FEV1 < 50% of predicted value; 14.Diffuse infiltrative gastric cancer; 15.Preoperatively confirmed tumor invasion of the dentate line or duodenum; 16.History of iodine allergy; 17.Refusal of laparoscopic surgery;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Common bile duct visualization rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Early postoperative complications;Postoperative recovery course;The rate and types of common bile duct variation;Number of dissected lymph nodes;The proportion of common bile duct injury;2-year overall survival;Number of positive lymph nodes;2-year recurrence pattern;Postoperative Nutritional Status and Quality of Life; | — |
Countries
China
Contacts
Public ContactWenbin Yu
Qilu Hospital of Shandong University
Outcome results
None listed