Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Radical Resection for Colorectal Cancer
Prospective Registry Study of Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Radical Resection for Colorectal Cancer
1 other identifier
observational
100
1 country
1
Brief Summary
Prospective registry study of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedStudy Start
First participant enrolled
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2021
CompletedAugust 24, 2020
August 1, 2020
8 months
December 17, 2019
August 20, 2020
Conditions
Outcome Measures
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.
During the operation
Study Arms (1)
endoscopic submucosal injection of indocyanine green
Interventions
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.
Eligibility Criteria
Patients who were to undergo indocyanine green fluorescence imaging for laparoscopicradical operation of colorectal cancer.
You may qualify if:
- Patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical operation of colorectal cancer.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jilin Universitylead
Study Sites (1)
the First Hospital of Jilin University
Changchun, Jilin, 130021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dong Yang, Master
The First Hospital of Jilin University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisted Investigator
Study Record Dates
First Submitted
December 17, 2019
First Posted
December 23, 2019
Study Start
April 15, 2020
Primary Completion
December 25, 2020
Study Completion
April 28, 2021
Last Updated
August 24, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share