Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Gastrectomy

• Conditions: Endoscopic Submucosal Injection of Indocyanine Green
• Interventions: Procedure: endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy

• Registration Number: NCT04143555
• Lead Sponsor: Jilin University

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.

Study Timeline

• Study First Submitted: 2019-10-27
• Study First Submitted QC: 2019-10-27
• Study First Posted: 2019-10-29
• Study Start: 2019-11-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-28
• Last Update Posted: 2021-03-02
• Primary Completion: 2021-04-10
• Study Completion: 2021-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
endoscopic submucosal injection of indocyanine green	endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy	-

Primary Outcome Measures

Name	Time	Method
The imaging effect of indocyanine green	During the operation	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.

Trial Locations

Locations (1)

the First Hospital of Jilin University; 🇨🇳 Chang chun, Jilin, China