Colorectal CancerNCT06508541
The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery
An observational study of Colorectal Cancer, run by Shanghai Tong Ren Hospital at 1 site in China.
Trial summary
Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- ICG Guided surgery and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 235 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 1 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients with newly diagnosed CRC who underwent CRC surgery between December 2016 and August 2021 in Shanghai Tongren hospital
Who may be able to join
- age \> 18 years,
- confirmed diagnosis of primary CRC,
- preoperative tumor stage of cT1 to cT4, N-/+, M0 as determined by contrast-enhanced computed tomography (CT),
- no distant metastasis, -American Society of Anesthesiologists(ASA)Physical Status Classification score of 1, 2, or 3-
Who cannot join
- history of previous colorectal surgery, emergent surgery, or palliative resection;
- pregnancy or breastfeeding;
- allergy or history of an adverse reaction to ICG; and
- severe mental disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery: a Retrospective Cohort Study
Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. The present study assessed the prognosis of colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging
- Conditions
- Colorectal Cancer
- Being tested
- ICG Guided surgery, conventional surgery
- Keywords
- Indocyanine green, Colorectal cancer, prognosis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG Guided surgeryProcedure or surgery
In ICG guided surgery group,Approximately 0.3 ml of ICG dissolved in 2.5 mg/ml of sterile water was injected submucosally by the endoscopic doctors through colonoscopy at two points around the tumor.All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure
conventional surgeryProcedure or surgery
All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose
| Study group | Role | What they receive |
|---|---|---|
| conventional surgery | All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose. Receives: Procedure: conventional surgery | |
| Indocyanine green fluorescence-guided surgery | Approximately 0.3 ml of ICG dissolved in 2.5 mg/ml of sterile water was injected submucosally by the endoscopic doctors through colonoscopy at two points around the tumor.All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure Receives: Procedure: ICG Guided surgery; Procedure: conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival(DFS)
the duration from radical surgery to the confirmation of recurrence or metastasis by regular or telephone follow-up
Measured: 1 month
Secondary outcomes (1)
the number of harvested lymph nodes
the number of harvested lymph nodes including positive and negative ones
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start15 Jul 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
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
- Retrospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Tong Ren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508541
- Sponsor's protocol ID
- 2024-06-001
- Status last verified
- Dec 2024
- First submitted
- 13 Jul 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06508541
- Acronym / sponsor ID
- 2024-06-001
- Conditions
- Colorectal Cancer
- Keywords
- Indocyanine green, Colorectal cancer, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Shanghai Tong Ren HospitalUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 18 Jul 2024 (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.
Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. The present study assessed the prognosis of colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional surgery | – | Procedure: conventional surgeryAll patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose. |
| Indocyanine green fluorescence-guided surgery | – | Procedure: ICG Guided surgery, Procedure: conventional surgeryApproximately 0.3 ml of ICG dissolved in 2.5 mg/ml of sterile water was injected submucosally by the endoscopic doctors through colonoscopy at two points around the tumor.All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with newly diagnosed CRC who underwent CRC surgery between December 2016 and August 2021 in Shanghai Tongren hospital
Key inclusion criteria (4 listed)
- age \> 18 years,
- confirmed diagnosis of primary CRC,
- preoperative tumor stage of cT1 to cT4, N-/+, M0 as determined by contrast-enhanced computed tomography (CT),
- no distant metastasis, -American Society of Anesthesiologists(ASA)Physical Status Classification score of 1, 2, or 3-
Key exclusion criteria (4 listed)
- history of previous colorectal surgery, emergent surgery, or palliative resection;
- pregnancy or breastfeeding;
- allergy or history of an adverse reaction to ICG; and
- severe mental disorder.
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 |
|---|---|---|
| ICG Guided surgeryIn ICG guided surgery group,Approximately 0.3 ml of ICG dissolved in 2.5 mg/ml of sterile water was injected submucosally by the endoscopic doctors through colonoscopy at two points around the tumor.All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure | Procedure or surgery | Indocyanine green fluorescence-guided surgery |
| conventional surgeryAll patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose | Procedure or surgery | Indocyanine green fluorescence-guided surgery, conventional surgery |
Primary outcome
disease-free survival(DFS)
Time frame: 1 month
the duration from radical surgery to the confirmation of recurrence or metastasis by regular or telephone follow-up
1 secondary outcome
the number of harvested lymph nodes
Time frame: 1month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Shanghai Tong Ren Hospital 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 16 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival(DFS) (time frame: 1 month). 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 16 Dec 2024.