Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Radical Resection for Colorectal Cancer

Overview

Prospective registry study of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer

Full Title of Study: “Prospective Registry Study of Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Radical Resection for Colorectal Cancer”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 25, 2020

Detailed Description

To observe the imaging result of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer, and analyze the relevant factors, so as to guide the submucosal injection of preoperative indocyanine green 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 resection for colorectal cancer.

Interventions

  • Procedure: endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancer
    • Indocyanine green was injected under endoscope within 24 hours before operation. Four points were evenlyinjected in four quadrants at the edge of the tumor. The patients with obstruction were injected at two points on the anal side of the tumor. The diluted concentration of indocyanine green was 0.625mg/ml or 1.25mg/ml. The injection method was direct submucosal injection and sandwich method. According to the imaging effect, it can be divided into local imaging and lymphatic drainage imaging. Tumor body: 0, no imaging; 1, full imaging; 2, diffuse imaging, overflow, interference with other areas of observation. Lymph drainage area imaging 0, no imaging; 1, full imaging; 2, diffuse imaging, overflow, interference with other areas of observation.

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. According to the imaging effect, it can be divided into local imaging and lymphatic drainage imaging. Tumor body: 0, no imaging; 1, full imaging; 2, diffuse imaging, overflow, interference with other areas of observation. Lymph drainage area imaging 0, no imaging; 1, full imaging; 2, diffuse imaging, overflow, interference with other areas of observation.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical operation of colorectal cancer.

Exclusion Criteria

  • have simultaneously other cancer
  • have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
  • have gastrointestinal surgery
  • Indocyanine green or iodine allergy
  • the period is too late or the tumor is too large to carry on a laparoscopic surgery.

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, Assisted Investigator – Jilin University
  • Overall Official(s)
    • Dong Yang, Master, Principal Investigator, First Hospital of Jilin University
  • Overall Contact(s)
    • Hong Xu, Professor, 18243052038, yd18243052038@163.com

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