Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Gastrectomy

Overview

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

Full Title of Study: “Prospective Registry Study of Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Gastrectomy”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 10, 2020

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

  • 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.

Arms, Groups and Cohorts

  • endoscopic submucosal injection of indocyanine green

Clinical Trial Outcome Measures

Primary Measures

  • The imaging effect of indocyanine green
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jilin University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dong Yang, Doctor – Jilin University
  • Overall Contact(s)
    • Hong Xu, Professor, 18243052038, yd18243052038@163.com

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