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Submucosal vs Subserosal ICG in Gastric Cancer Lymphadenectomy
NCT04219332Phase 3
Key facts
- Status
- Unknown
- Start
- Dec 2019
- Primary completion
- Nov 2020
- Countries
- 1
- Sponsor
- Fujian Medical University
- Modality
- Small Molecules
- Drugs
- indocyanine green
- Conditions
- gastric cancer (GC)
01
Overview
Phase 3, randomised, open-label trial of indocyanine green in gastric cancer (GC) (2 arms), sponsored by Fujian Medical University. Primary endpoint: Total Number of Retrieved Lymph Nodes at 1 month. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Subserosal ICG
Intraoperative subserosal injection of ICG
Submucosal ICG
Preoperative submucosal injection of ICG (1 day prior)
03
Who it enrols
Patients aged 18-75 with primary gastric adenocarcinoma (cT1-4a, N0/+, M0) undergoing laparoscopic resection, ECOG 0-1, ASA I-III. Excludes prior neoadjuvant therapy, prior upper abdominal surgery, and bulky lymph nodes >3cm.
04
Endpoints
Primary
Total Number of Retrieved Lymph Nodes
Secondary
Total number of fluorescent lymph nodes
Relationship between fluorescent lymph nodes and positive lymph nodes (true positive rate)
Relationship between fluorescent lymph nodes and negative lymph nodes (false positive rate)
Relationship between non-fluorescent and negative lymph nodes (true negative rate)
Relationship between non-fluorescent lymph nodes and positive lymph nodes (false negative rate)
Number of Metastasis Lymph Nodes
Metastasis rate of lymph node
Mortality rates
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