CClinicalTrials.gg
Status unknownNCT04207489Updated Aug 24, 2020

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

An observational study in Colorectal Cancer and Indocyanine Green, sponsored by Jilin University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-08-24.

Sponsored by Jilin University · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Colorectal Cancer
  • Indocyanine Green
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 100 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Jilin University is the lead sponsor of 26 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who were to undergo indocyanine green fluorescence imaging for laparoscopicradical operation of colorectal cancer.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • endoscopic submucosal injection of indocyanine green

    Procedure: endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancer

Interventions

  • Procedureendoscopic 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.

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What researchers measure

Primary outcomes

  1. The imaging effect of indocyanine green

    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.

    Time frame: During the operation

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Study locations

1 of 1 sites recruiting
  • the First Hospital of Jilin University
    Chang chun, Ji Lin 130021, China
    • Dong Yang, Master · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04207489
Lead sponsor
Jilin University
Responsible party
Dong Yang (Assisted Investigator, Jilin University) — Principal investigator
First posted
Dec 23, 2019
Start date
Apr 15, 2020
Primary completion
Dec 25, 2020 (estimated)
Completion
Apr 28, 2021 (estimated)
Last update
Aug 24, 2020

Study contacts

Hong Xu, Professor
Contact
yd18243052038@163.com
18243052038
Dong Yang, Master
Contact
714488468@qq.com
Dong Yang, Master
principal investigator · The First Hospital of Jilin University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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