Colorectal CancerNCT04207489
Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Radical Resection for Colorectal Cancer
An observational study of Colorectal Cancer and Indocyanine Green, run by Jilin University at 1 site in China.
Trial summary
Prospective registry study of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Indocyanine Green
- What is being tested?
- endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancer
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2020to 28 Apr 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were to undergo indocyanine green fluorescence imaging for laparoscopicradical operation of colorectal cancer.
Who may be able to join
- Patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical operation of colorectal cancer.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Dong Yang, Master contact
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Changchun, Jilin, 130021
Dong Yang, Master
About this study
Official title: Prospective Registry Study of 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
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.
- Conditions
- Colorectal Cancer, Indocyanine Green
- Being tested
- endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancerProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| endoscopic submucosal injection of indocyanine green | Not described Receives: Procedure: endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start15 Apr 2020
- Primary completion25 Dec 2020 (estimated)
- Study completion28 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Yang, Jilin University
- Investigators
- Dong Yang, Master, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207489
- Sponsor's protocol ID
- 130003
- Status last verified
- Aug 2020
- First submitted
- 17 Dec 2019
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry Study of Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Radical Resection for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04207489
- Acronym / sponsor ID
- 130003
- Conditions
- Colorectal Cancer, Indocyanine Green
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 25 Dec 2020 (estimated)
- Study completion
- 28 Apr 2021 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective registry study of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endoscopic submucosal injection of indocyanine green | – | Procedure: endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were to undergo indocyanine green fluorescence imaging for laparoscopicradical operation of colorectal cancer.
Key inclusion criteria (1 listed)
- Patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical operation of colorectal cancer.
Key exclusion criteria (5 listed)
- have simultaneously other cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancerIndocyanine 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. | Procedure or surgery | endoscopic submucosal injection of indocyanine green |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Yang, Master contact
Dong Yang, Master principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Indocyanine Green, run by Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Xu, Professor (18243052038, yd18243052038@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The imaging effect of indocyanine green (time frame: During the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.