Gastric Cancer
Conditions
Keywords
Indocyanine Green Tracer, Laparoscopic Gastrectomy, Remnant Gastric Cancer
Brief summary
Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.
Detailed description
Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.
Interventions
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer
Sponsors
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age from 18 to 75 years 2. Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition) (4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby 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) class 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 and gastrectomy) 4. History of previous gastric surgery (including ESD/EMR for gastric cancer) 5. Rejection of laparoscopic resection 6. History of allergy to iodine agents 7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging 8. History of other malignant disease within past five years 9. History of previous neoadjuvant chemotherapy or radiotherapy 10. History of unstable angina or myocardial infarction within the past six months 11. History of unstable angina or myocardial infarction within past six months 12. History of continuous systematic administration of corticosteroids within one month 13. Requirement of simultaneous surgery for another disease 14. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer 15. FEV1\<50% of the predicted values 16. Linitis plastica, Widespread
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Retrieved Lymph Nodes | 30 days | Total Number of Retrieved Lymph Nodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group | 30 days | Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group |
| Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate) | 30 days | Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate) |
| Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate) | 30 days | Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate) |
| Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate) | 30 days | Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate) |
| Number of Metastasis Lymph Nodes | 30 days | Number of Metastasis Lymph Nodes |
| Metastasis rate of lymph node | 30 days | Metastasis rate of lymph node |
| Lymph node noncompliance rate | 30 days | Lymph node noncompliance rate |
| Postoperative mortality rate | 30 days | Postoperative mortality rate |
| 3-year overall survival rate | 3 years | 3-year overall survival rate |
| 3-year disease-free survival rate | 3 years | 3-year disease-free survival rate |
| 3-year recurrence pattern | 3 years | 3-year recurrence pattern |
| Postoperative recovery course | 30 days | Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay |
| Intraoperative situation | 30 days | Operation time, intraoperative blood loss, and intraoperative morbidity rate |
| Postoperative morbidity rate | 30 days | Postoperative morbidity rate |
Countries
China
Contacts
Primary ContactHualong Zheng
Outcome results
None listed