Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

• Status: Recruiting
• Trial end date: 2028-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Medical University

Criteria

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