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Clinical Trials in China / NCT05618821
Recruiting Phase 2

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

NCT05618821 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Medical University
Phase
Phase 2
Started
2022-06-03
Last updated
2022-11-16

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

Indocyanine Green Tracer

Indocyanine Green Tracer: Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting

More Fujian Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05618821 on ClinicalTrials.gov ↗ ← All trials in China