Endoscopic Submucosal Injection of Indocyanine GreenNCT04143555
Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Gastrectomy
An observational study of Endoscopic Submucosal Injection of 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 gastrectomy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endoscopic Submucosal Injection of Indocyanine Green
- What is being tested?
- endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2019to 20 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 laparoscopic radical gastrectomy for gastric cancer
Who may be able to join
- patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical gastrectomy.
Who cannot join
- 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
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
Hong Xu, Professor, yd18243052038@163.com
Dong Yang, Master, 714488468@qq.com
About this study
Official title: 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
Read the 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.
- Being tested
- endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy
- Keywords
- endoscopic submucosal injection, indocyanine green
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 gastrectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| endoscopic submucosal injection of indocyanine green | Not described Receives: Procedure: endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy |
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. 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.
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 posted29 Oct 2019
- Study start20 Nov 2019
- Primary completion10 Apr 2021 (estimated)
- Study completion20 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Submucosal Injection of Indocyanine GreenStudies 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
- 130 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143555
- Sponsor's protocol ID
- 130002
- Status last verified
- Feb 2021
- First submitted
- 27 Oct 2019
- Last updated
- 2 Mar 2021
- 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 2 Mar 2021. 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 Gastrectomy
- ClinicalTrials.gov ID
- NCT04143555
- Acronym / sponsor ID
- 130002
- Keywords
- endoscopic submucosal injection, indocyanine green
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 10 Apr 2021 (estimated)
- Study completion
- 20 Apr 2021 (estimated)
- First posted
- 29 Oct 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 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 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 gastrectomy |
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 laparoscopic radical gastrectomy for gastric cancer
Key inclusion criteria (1 listed)
- patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical gastrectomy.
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 gastrectomyIndocyanine 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. | 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. 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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
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 Endoscopic Submucosal Injection of 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 2 Mar 2021. 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 2 Mar 2021.