Sigmoid CancerNCT06396806
A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer
A study testing indocyanine green fluorescence imaging lymphatic tracing in people with Sigmoid Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
he purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic radical sigmoidectomy for sigmoid adenocarcinoma (cT2-T4a N0 M0，T1-T4a N+ M0). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sigmoid Cancer
- What is being tested?
- indocyanine green fluorescence imaging lymphatic tracing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,072 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2024to 31 Dec 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old
- Confirmed sigmoid adenocarcinoma cancer pathologically
- Location of tumor: the sigmoid colon (descending colon from vertical to horizontal point) is the starting point of sigmoid colon, and the end point of sigmoid colon is at 15cm of anal margin.
- CT showed sigmoid colon cancer: T3-4a N+ M0
- Patients with non-local recurrence or distant metastasis;
- no multiple colorectal cancer;
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- no neoadjuvant therapy;
- physical conditions such as heart, lung, liver and kidney function can tolerate surgery.
- Willing and able to provide written informed consent for participation in this study
Who cannot join
- Complicated with other malignant tumors or previous history of malignant tumors;
- patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
- patients with tumor invasion or involvement of adjacent organs requiring combined organ resection;
- patients with poor anal function and incontinence before operation;
- patients with inflammatory bowel disease or familial adenomatous polyposis
- ASA grade ≥ IV and / or ECOG physical status score > 2;
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- patients with severe hepatorenal function, cardiopulmonary function, blood coagulation dysfunction or severe underlying diseases unable to tolerate surgery;
- history of severe mental illness;
- pregnant or lactating women;
- patients with uncontrolled infection before operation;
- patients with other clinical and laboratory conditions considered by some researchers should not participate in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun yat-sen University, Sixth Affiliated Hospital
Guangzhou, Guangdong, 510655
About this study
he purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic radical sigmoidectomy for sigmoid adenocarcinoma (cT2-T4a N0 M0，T1-T4a N+ M0).
- Conditions
- Sigmoid Cancer
- Being tested
- indocyanine green fluorescence imaging lymphatic tracing
- Medical subject headings
- Sigmoid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine green fluorescence imaging lymphatic tracingProcedure or surgery
At the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results.
| Study group | Role | What they receive |
|---|---|---|
| radical sigmoidectomy | No intervention | radical sigmoidectomy |
| radical sigmoidectomy combined with indocyanine green fluorescence imaging | Experimental | At the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results. Receives: Procedure: indocyanine green fluorescence imaging lymphatic tracing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival rate
odisease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
Measured: 3 years after the surgery
Secondary outcomes (18)
Total number of retrieved lymph nodes
Compare total number of retrieved lymph nodes in both group
Measured: 14 days after the surgery
Number of Metastasis Lymph Nodes
Compare number of positive lymph nodes in both group.
Measured: 14 days after the surgery
The number of lymph nodes at each station
Measured: 14 days after the surgery
The rate of fluorescence
The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
Measured: 14 days after the surgery
Positive rate
The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
Measured: 14 days after the surgery
False positive rate
The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
Measured: 14 days after the surgery
Negative rate
The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
Measured: 14 days after the surgery
False negative rate
The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
Measured: 14 days after the surgery
Morbidity rate
This is for the early postoperative complication
Measured: 30 days after the surgery
mortality rate
mortality, which defined as the event observed within 30 days after surgery
Measured: 30 days after the surgery
Pathological outcomes checklist
Quality of the mesorectum specimen, number of harvested lymph nodes, status of circumferential resection margin, and distal resection margin
Measured: 14 days after the surgery
3-year Overall survival rate
Overall survival was defined as the time from surgery to death from any cause
Measured: 3 years after the surgery
5-year Overall survival rate
Overall survival was defined as the time from surgery to death from any cause
Measured: 5 years after the surgery
5-year Disease-free survival rate
Measured: 5 years after the surgery
Local recurrence rate
Local recurrence was defined as radiologic or histopathologic evidence of any recurrent disease deposit located in the pelvis in the prior area of dissection following a primary rectal cancer resection, with or without distal metastasis.
Measured: 3 years after the surgery
Postoperative function (voiding function, sexual function) and quality of life
Measured: 3 years after the surgery
The correlation between the number of lymph nodes and 3-year overall survival rate and 3-year disease-free survival rate
Measured: 3 years after the surgery
Minimal Residual Disease, MRD
Measured: 3 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start6 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sigmoid CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 1,072 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396806
- Sponsor's protocol ID
- GIHSYSU-35
- Status last verified
- Jan 2025
- First submitted
- 30 Apr 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer
- ClinicalTrials.gov ID
- NCT06396806
- Acronym / sponsor ID
- GIHSYSU-35
- Conditions
- Sigmoid Cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,072 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 May 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.
he purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic radical sigmoidectomy for sigmoid adenocarcinoma (cT2-T4a N0 M0，T1-T4a N+ M0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radical sigmoidectomy | No intervention | –radical sigmoidectomy |
| radical sigmoidectomy combined with indocyanine green fluorescence imaging | Experimental | Procedure: indocyanine green fluorescence imaging lymphatic tracingAt the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 75 years old
- Confirmed sigmoid adenocarcinoma cancer pathologically
- Location of tumor: the sigmoid colon (descending colon from vertical to horizontal point) is the starting point of sigmoid colon, and the end point of sigmoid colon is at 15cm of anal margin.
- CT showed sigmoid colon cancer: T3-4a N+ M0
- Patients with non-local recurrence or distant metastasis;
Key exclusion criteria (11 listed)
- Complicated with other malignant tumors or previous history of malignant tumors;
- patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
- patients with tumor invasion or involvement of adjacent organs requiring combined organ resection;
- patients with poor anal function and incontinence before operation;
- patients with inflammatory bowel disease or familial adenomatous polyposis
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 |
|---|---|---|
| indocyanine green fluorescence imaging lymphatic tracingAt the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results. | Procedure or surgery | radical sigmoidectomy combined with indocyanine green fluorescence imaging |
Primary outcome
Disease-free survival rate
Time frame: 3 years after the surgery
odisease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
18 secondary outcomes
Total number of retrieved lymph nodes
Time frame: 14 days after the surgery
Number of Metastasis Lymph Nodes
Time frame: 14 days after the surgery
The number of lymph nodes at each station
Time frame: 14 days after the surgery
The rate of fluorescence
Time frame: 14 days after the surgery
Positive rate
Time frame: 14 days after the surgery
False positive rate
Time frame: 14 days after the surgery
Negative rate
Time frame: 14 days after the surgery
False negative rate
Time frame: 14 days after the surgery
Morbidity rate
Time frame: 30 days after the surgery
mortality rate
Time frame: 30 days after the surgery
Pathological outcomes checklist
Time frame: 14 days after the surgery
3-year Overall survival rate
Time frame: 3 years after the surgery
5-year Overall survival rate
Time frame: 5 years after the surgery
5-year Disease-free survival rate
Time frame: 5 years after the surgery
Local recurrence rate
Time frame: 3 years after the surgery
Postoperative function (voiding function, sexual function) and quality of life
Time frame: 3 years after the surgery
The correlation between the number of lymph nodes and 3-year overall survival rate and 3-year disease-free survival rate
Time frame: 3 years after the surgery
Minimal Residual Disease, MRD
Time frame: 3 years after the surgery
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 17 Jan 2025.
- 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.
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 indocyanine green fluorescence imaging lymphatic tracing in people with Sigmoid Cancer, run by Sun Yat-sen 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 9 inclusion and 11 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 17 Jan 2025. 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 rate (time frame: 3 years after the surgery). 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 17 Jan 2025.