Gastric Cancer, Lymph Node Metastases
Conditions
Brief summary
Patients with locally advanced gastric adenocarcinoma (cT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic D2 lymph node dissection for gastric cancer after neoadjuvant chemotherapy by comparing injection ICG group and non-injection ICG group
Interventions
DRUGIndocyanine Green
Indocyanine Green Tracer Using in Laparoscopic Gastrectomy with Lymph Node Dissection for Locally Advanced Gastric Cancer After Neoadjuvant
Sponsors
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Group A (Study Group): Laparoscopic gastrectomy group with the use of near-infrared imaging (ICG group) Group B (Control Group): Laparoscopic gastrectomy group without the use of near-infrared imaging (Non-ICG group)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age from 18 to 75 years 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition 4. No distant metastasis, no invasion of pancreas, spleen or other adjacent organs in the preoperative examinations 5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale 6. ASA (American Society of Anesthesiology) score I to III 7. Written informed consent
Exclusion criteria
1. Women during pregnancy or breast-feeding 2. Severe mental disorder 3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) 4. History of previous gastric surgery (including ESD/EMR for gastric cancer) 5. Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging. 6. Other malignant disease within the past 5 years 7. History of previous neoadjuvant chemotherapy or radiotherapy 8. History of unstable angina or myocardial infarction within past six months 9. History of cerebrovascular accident within past six months 10. History of continuous systematic administration of corticosteroids within one month 11. Requirement for simultaneous surgery for other disease 12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 13. FEV1 (forced expiratory volume in one second)\<50% of predicted values 14. Diffuse invasive gastric cancer 15. Preoperatively, tumors involving the squamocolumnar junction or duodenum were confirmed 16. A history of iodine allergy 17. Refuse laparoscopic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival rate | 3 years | Disease-free survival is calculated from the day of surgery to the day of recurrence (When the specific date of recurrence of the tumor is unknown, the ending point is the date of death due to tumor causes). In the event that neither death nor recurrence of the tumor are observed, the end point is the final date that a patient is confirmed as relapse-free. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of retrieved lymph nodes | 30 days | Total number of retrieved lymph nodes |
Countries
China
Outcome results
None listed