NCT04143555

Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Gastrectomy

Prospective Registry Study of Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Gastrectomy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective registry study of endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy

Detailed description

To observe the imaging result of endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy, and analyze the relevant factors, so as to guide the operation of preoperative indocyanine green submucosal injection better. This study is prospective and observational. In order to analyze the related factors that affect the imaging effect, we enrolled patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical gastrectomy.

Conditions

• Endoscopic Submucosal Injection of Indocyanine Green

Interventions

Type	Name	Description
PROCEDURE	endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy	Indocyanine green was injected under endoscope within 24 hours before operation. Four points(0.5ml/point,1.25mg/ml) were evenly injected in four quadrants at the edge of the tumor. The injection method was direct submucosal injection and 0.5ml saline + 0.5ml indocyanine green solution + 0.5ml saline (sandwich method). The imaging effect was evaluated by indocyanine green fluorescence imaging system during the operation. The effect was divided into grade0 and Grade1. Grade1: The imaging of the tumor and the corresponding lymphatic drainage area in the injection area both were ideal. Grade 0: not up to grade 1, classified into tumor body and drainage area without imaging, only tumor body imaging, and even though tumor body and regional lymph drainage area imaging, the contrast agent in the gastric wall was too diffuse or even overflowing, which seriously interfered with the observation of lymph drainage area imaging.

Timeline

• Start date: 2019-11-20
• Primary completion: 2021-04-10
• Completion: 2021-04-20
• First posted: 2019-10-29
• Last updated: 2021-03-02

Locations

1 site across 1 country: China