Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Gastrectomy

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

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

Study Overview

• Status: Unknown
• Conditions: Endoscopic Submucosal Injection of Indocyanine Green
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

• Study Contact: Name: Hong Xu, Professor; Phone Number: 18243052038; Email: yd18243052038@163.com

Study Locations

• China
  • Jilin
    • Chang chun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Hong Xu, Professor; Email: yd18243052038@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical gastrectomy for gastric cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

endoscopic submucosal injection of indocyanine green

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The imaging effect of indocyanine green	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.	During the operation

Collaborators and Investigators

• Sponsor: Jilin University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2019
• Primary Completion (ANTICIPATED): April 10, 2021
• Study Completion (ANTICIPATED): April 20, 2021

Study Registration Dates

• First Submitted: October 27, 2019
• First Submitted That Met QC Criteria: October 27, 2019
• First Posted (ACTUAL): October 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 28, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: indocyanine green; endoscopic submucosal injection
• Other Study ID Numbers: 130002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No