Colorectal Cancer Stage IIINCT06583564
The Prognosis Effect of Indocyanine Green (ICG) Fluorescence Guided Surgery on Disease-free Survival (DFS) of Stage III Colorectal Cancer
A study testing ICG lymphangiography procedure in people with Colorectal Cancer Stage III, 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 Stage III
- What is being tested?
- ICG lymphangiography procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
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, and
- 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
- severe mental disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single Center Randomized Controlled Study of the Prognosis After Indocyanine Green Fluorescence-guided Radical Surgery in Colorectal Cancer Patients of Stage III
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 stage III colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging
- Conditions
- Colorectal Cancer Stage III
- Being tested
- ICG lymphangiography procedure
- Keywords
- Colorectal cancer, Indocyanine green, 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 lymphangiography procedureProcedure or surgery
All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure
| Study group | Role | What they receive |
|---|---|---|
| ICG group | Experimental | 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 lymphangiography procedure |
| Non-ICG group | No intervention | All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS) rate
the rate of of no recurrence or metastasis after 3 years from radical surgery
Measured: From radical surgery to the end of follow-up ,up to 36 months
Secondary outcomes (3)
the number of harvested lymph nodes
the number of harvested lymph nodes of radical surgery
Measured: From radical surgery to the end of perioperative period at 1 month
Postoperative complications
Postoperative complications ICG-related complications, surgery-related complications, and systemic complications. Postoperative complications were graded according to the Clavien-Dindo system
Measured: From radical surgery to the end of perioperative period at 1 month
Overall survival rate
the rate of 3 years overall survival after radical surgery
Measured: From radical surgery to the end of follow-up ,up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start27 Sep 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Stage IIIStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
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
- NCT06583564
- Sponsor's protocol ID
- 2024-038-01
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Randomized Controlled Study of the Prognosis After Indocyanine Green Fluorescence-guided Radical Surgery in Colorectal Cancer Patients of Stage III
- ClinicalTrials.gov ID
- NCT06583564
- Acronym / sponsor ID
- 2024-038-01
- Conditions
- Colorectal Cancer Stage III
- Keywords
- Colorectal cancer, Indocyanine green, prognosis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Shanghai Tong Ren HospitalUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 4 Sep 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 stage III colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICG group | Experimental | Procedure: ICG lymphangiography procedureApproximately 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 |
| Non-ICG group | No intervention | –All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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, and
- 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
- 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 lymphangiography procedureAll patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure | Procedure or surgery | ICG group |
Primary outcome
Disease-free survival (DFS) rate
Time frame: From radical surgery to the end of follow-up ,up to 36 months
the rate of of no recurrence or metastasis after 3 years from radical surgery
3 secondary outcomes
the number of harvested lymph nodes
Time frame: From radical surgery to the end of perioperative period at 1 month
Postoperative complications
Time frame: From radical surgery to the end of perioperative period at 1 month
Overall survival rate
Time frame: From radical surgery to the end of follow-up ,up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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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.
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?
A study testing ICG lymphangiography procedure in people with Colorectal Cancer Stage III, 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 5 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: enrolling by invitation, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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) rate (time frame: From radical surgery to the end of follow-up ,up to 36 months). 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 22 Jun 2026.