Randomized Controlled Trial on Effect of Lymph Node Mapping by Indocyanine Green Via Submucosal or Subserosal Injection

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

266

Participants

Timeline

Start Date

December 31, 2019

Primary Completion Date

November 27, 2020

Study Completion Date

October 28, 2023

Conditions
Indocyanine GreenGastric CancerInjection Site
Interventions
DRUG

Subserosa injection of indocyanine green

After preoperative exploration, the indocyanine green powder (Dandong Yichuang Pharmaceutical Co) is dissolved in 0.5 mg/ml of sterile water and the prepared solution (1.5 ml for each point) is injected along the subserosal of the stomach at 6 specific points along the lesser and greater curvature of the stomach.

DRUG

submucosal injection of indocyanine green

One day before surgery, 1.25 mg/ml indocyanine green (Dandong Yichuang Pharmaceutical Co) was prepared in sterile water and 0.5 ml of the solution was injected into the submucosal layer at 4 quadrants around the primary tumor, amounting to 2.5 mg of indocyanine green.

Trial Locations (1)

Unknown

Department of Gastric Surgery, Fuzhou

All Listed Sponsors
lead

Fujian Medical University

OTHER