An interventional study of indocyanine green fluorescence imaging lymphatic tracing in Sigmoid Cancer, sponsored by Sun Yat-sen University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
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).
20 studies on the registry are indexed under Sigmoid Neoplasms; 5 are open to participants now.
This study's planned enrollment of 1,072 is above the median of 55 across 14 interventional studies indexed under Sigmoid Neoplasms.
Browse Sigmoid Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
radical sigmoidectomy
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.
Procedure: indocyanine green fluorescence imaging lymphatic tracing
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.
Disease-free survival rate
odisease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
Time frame: 3 years after the surgery
Total number of retrieved lymph nodes
Compare total number of retrieved lymph nodes in both group
Time frame: 14 days after the surgery
Number of Metastasis Lymph Nodes
Compare number of positive lymph nodes in both group.
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
The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 14 days after the surgery
Morbidity rate
This is for the early postoperative complication
Time frame: 30 days after the surgery
mortality rate
mortality, which defined as the event observed within 30 days after surgery
Time frame: 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
Time frame: 14 days after the surgery
3-year Overall survival rate
Overall survival was defined as the time from surgery to death from any cause
Time frame: 3 years after the surgery
5-year Overall survival rate
Overall survival was defined as the time from surgery to death from any cause
Time frame: 5 years after the surgery
5-year Disease-free survival rate
Time frame: 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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Dec 2027, 43 months after the start.
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