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Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Gastrectomy

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04143555
Enrollment
130
Registered
2019-10-29
Start date
2019-11-20
Completion date
2021-04-20
Last updated
2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Submucosal Injection of Indocyanine Green

Keywords

endoscopic submucosal injection, indocyanine green

Brief 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.

Interventions

PROCEDUREendoscopic 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.

Sponsors

Jilin University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical gastrectomy.

Exclusion criteria

* have simultaneously other cancer * have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases * have upper gastrointestinal surgery * Indocyanine green or iodine allergy * the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy

Design outcomes

Primary

MeasureTime frameDescription
The imaging effect of indocyanine greenDuring the operationThe 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.

Countries

China

Contacts

Primary ContactHong Xu, Professor
yd18243052038@163.com18243052038
Backup ContactDong Yang, Master
714488468@qq.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026