Rectal Cancer Stage IIINCT05830890
Sentinel Lymph Node Biopsy in Rectal Cancer
A study testing Sentinel lymph node biopsy, Indocyanine green solution and fluorescence laparoscope in people with Rectal Cancer Stage III and Rectal Cancer Stage IV, run by National Cancer Center, China at 1 site in China.
Trial summary
Rectal cancer is one of the most common malignant tumors, with 9% to 23% of patients experiencing pelvic sidewall lymph node metastasis. According to the current Chinese guidelines for diagnosing and treating colorectal cancer, pelvic sidewall lymph node dissection is recommended for patients who have experienced or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer Stage III, Rectal Cancer Stage IV
- What is being tested?
- Sentinel lymph node biopsy, Indocyanine green solution and fluorescence laparoscope
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- May 2023to Dec 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
- Newly diagnosed patients with confirmed rectal cancer by histopathology.
- Preoperative clinical staging by imaging examination is T3-4.
- Preoperative colonoscopy shows the distance from the tumor's lower edge to the anus is less than 10cm.
- No previous chemotherapy or radiotherapy.
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- Preoperative imaging examination (pelvic enhanced MRI) shows lateral lymph nodes with a maximum short diameter of ≥5mm and <10mm.
- Women of childbearing age must take effective contraceptive measures.
- Able to understand the study and sign the informed consent form.
Who cannot join
- Complete intestinal obstruction.
- Active hepatitis and peripheral neuropathy (such as peripheral neuritis, pseudomeningitis, motor neuritis, sensory disturbances, etc.).
- Pregnant or lactating women; women of childbearing potential who have not taken sufficient contraceptive measures.
- History of other tumors or previous chemotherapy or radiotherapy.
- Alcoholism or drug addiction.
- Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation.
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- Hypoproteinemia.
- Preprandial blood glucose control exceeds 11.2mmol/L in the week before surgery.
- BMI>28 kg/m^2.
- Poor compliance, and failure to comply with the study protocol.
- Subject withdrawal from the study
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center
Beijing, Beijing Municipality, 100000
Haitao Zhou, M.D., +8613381167333, zhouhaitao01745@163.com
Yueyang Zhang, M.D., +8613552910035, yyzhang0129@163.com
About this study
Official title: A Clinical Trial of Sentinel Lymph Node Biopsy in Rectal Cancer
Rectal cancer is one of the most common malignant tumors, with 9% to 23% of patients experiencing pelvic sidewall lymph node metastasis. According to the current Chinese guidelines for diagnosing and treating colorectal cancer, pelvic sidewall lymph node dissection is recommended for patients who have experienced or are suspected of having lateral lymph node metastasis. Lateral lymph node dissection can result in longer operation times, increased bleeding, and complications such as urinary and sexual dysfunction after surgery. Currently, the presence of metastasis is primarily determined by the size and enhancement characteristics of lateral lymph nodes observed through imaging studies. However, the pathological lymph node metastasis rate of specimens collected after lateral lymph node dissection based on current imaging criteria is only 20.5%. Therefore, a pressing clinical challenge is accurately determining the presence of lateral lymph node metastasis and avoiding unnecessary lateral lymph node dissection in patients who have not experienced lateral lymph node metastasis.
Sentinel lymph node biopsy has been widely used in clinical practice. It has replaced traditional lymph node dissection in some breast cancer and melanoma patients, reducing surgical risks and complications and improving patients' quality of life. This study aims to use indocyanine green as a tracer for fluorescence-guided laparoscopic navigation to locate the lateral sentinel lymph nodes of rectal cancer in the pelvic cavity. By studying the accuracy, specificity, and false-negative rate of predicting lateral lymph node status using the sentinel lymph node, we can further clarify the clinical significance of the lateral sentinel lymph node.
Read the detailed description
This study is a prospective single-arm clinical study. 87 patients with middle and low rectal cancer are planned to be included in the study. After general anesthesia during the operation, indocyanine green is injected around the tumor through the anus. After the sentinel lymph nodes are developed and located by fluorescent laparoscopy, they are removed and sent to rapid frozen pathological examination, and then the lateral lymph nodes are cleaned. Through pathological examination and statistical analysis of the fluorescent stained lateral sentinel lymph nodes and all the cleaned lateral lymph nodes, To evaluate the clinical significance of lateral sentinel lymph nodes located by this technique in predicting the status of lateral lymph nodes.
- Conditions
- Rectal Cancer Stage III, Rectal Cancer Stage IV
- Being tested
- Sentinel lymph node biopsy, Indocyanine green solution, fluorescence laparoscope, pathological examination, rapid frozen pathological examination
- Keywords
- Laparoscope, Rectal cancer, Indocyanine green, Sentinel lymph node, lymph node dissection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node biopsyProcedure or surgery
Also called Lateral lymph nodes dissection
After the total mesorectal excision, the indocyanine green was injected around the tumor via the anus. The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed and sent for rapid frozen pathological examination. Subsequently, a lateral lymph node dissection was performed.
Indocyanine green solutionDrug
Also called Indocyanine green fluorescence imaging
Indocyanine green was injected around the tumor via the anus to visualize the sentinel lymph nodes under the fluorescence laparoscope.
fluorescence laparoscopeDevice
The fluorescence laparoscope was used to visualize and locate the sentinel lymph node.
pathological examinationDiagnostic test
The surgical specimens and sentinel lymph nodes were routinely examined for pathology.
rapid frozen pathological examinationDiagnostic test
The lateral green fluorescence imaging sentinel lymph nodes found during surgery was sent to make cryosections. And then a pathologist makes a rapid diagnosis under a microscope。
total mesorectal excisionProcedure or surgery
Also called TME
- Sharply dissect the vascular interface between the pelvic fascia parietal layer and the visceral layer around the mesentery under direct vision to ensure that the rectal mesentery of the resected specimen is intact and tearless.
- For medium and low rectal cancer: the distal intestinal tube of the tumor should be resected ≥ 2 cm.
- TME or mesenteric distal resection margin ≥ 5 cm away from the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Lymph Node Biopsy | Experimental | The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed. Receives: Procedure: Sentinel lymph node biopsy; Drug: Indocyanine green solution; Device: fluorescence laparoscope; Diagnostic Test: pathological examination; Diagnostic Test: rapid frozen pathological examination; Procedure: total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
False negative rate
The false negative rate of predicting lateral lymph node metastasis status using rapid frozen pathology results of lateral sentinel lymph nodes in mid-to-low rectal cancer.
Namely, the false negative rate= total false negative cases/(total false negative cases+total true positive cases).
Measured: up to 14 days
Accuracy
The accuracy of predicting lateral lymph node metastasis status using rapid frozen pathology results of lateral sentinel lymph nodes in mid-to-low rectal cancer.
Namely, the accuracy = (total true negative cases+total true positive cases)/total number of cases.
Measured: up to 14 days
Secondary outcomes (3)
Detection rate
The detection rate of lateral sentinel lymph nodes in middle and low rectal cancer.
Namely, the detection rate = (total true positive cases+total false positive cases)/total number of cases.
Measured: up to 14 days
Specificity
The specificity of predicting lateral lymph node metastasis status using rapid frozen pathology results of lateral sentinel lymph nodes in mid-to-low rectal cancer.
Namely, the specificity = total true negative cases/(total true negative cases+total false positive cases).
Measured: up to 14 days
Sensitivity
The Sensitivity of predicting lateral lymph node metastasis status using rapid frozen pathology results of lateral sentinel lymph nodes in mid-to-low rectal cancer.
Namely, the sensitivity= total true positive cases/(total true positive cases+total false negative cases)。
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitao Zhou, National Cancer Center, China
- Investigators
- Haitao Zhou, M.D., Study chair, National Cancer Center, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830890
- Sponsor's protocol ID
- SLNB
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' data are only allowed to be used for the analysis of this study and are not authorized to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Sentinel Lymph Node Biopsy in Rectal Cancer
- ClinicalTrials.gov ID
- NCT05830890
- Acronym / sponsor ID
- SLNB
- Conditions
- Rectal Cancer Stage III, Rectal Cancer Stage IV
- Keywords
- Laparoscope, Rectal cancer, Indocyanine green, Sentinel lymph node, lymph node dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- National Cancer Center, ChinaUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Apr 2023 (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.
Rectal cancer is one of the most common malignant tumors, with 9% to 23% of patients experiencing pelvic sidewall lymph node metastasis. According to the current Chinese guidelines for diagnosing and treating colorectal cancer, pelvic sidewall lymph node dissection is recommended for patients who have experienced or are suspected of having lateral lymph node metastasis. Lateral lymph node dissection can result in longer operation times, increased bleeding, and complications such as urinary and sexual dysfunction after surgery. Currently, the presence of metastasis is primarily determined by the size and enhancement characteristics of lateral lymph nodes observed through imaging studies. However, the pathological lymph node metastasis rate of specimens collected after lateral lymph node dissection based on current imaging criteria is only 20.5%. Therefore, a pressing clinical challenge is accurately determining the presence of lateral lymph node metastasis and avoiding unnecessary lateral lymph node dissection in patients who have not experienced lateral lymph node metastasis.
Sentinel lymph node biopsy has been widely used in clinical practice. It has replaced traditional lymph node dissection in some breast cancer and melanoma patients, reducing surgical risks and complications and improving patients' quality of life. This study aims to use indocyanine green as a tracer for fluorescence-guided laparoscopic navigation to locate the lateral sentinel lymph nodes of rectal cancer in the pelvic cavity. By studying the accuracy, specificity, and false-negative rate of predicting lateral lymph node status using the sentinel lymph node, we can further clarify the clinical significance of the lateral sentinel lymph node.
Detailed description
This study is a prospective single-arm clinical study. 87 patients with middle and low rectal cancer are planned to be included in the study. After general anesthesia during the operation, indocyanine green is injected around the tumor through the anus. After the sentinel lymph nodes are developed and located by fluorescent laparoscopy, they are removed and sent to rapid frozen pathological examination, and then the lateral lymph nodes are cleaned. Through pathological examination and statistical analysis of the fluorescent stained lateral sentinel lymph nodes and all the cleaned lateral lymph nodes, To evaluate the clinical significance of lateral sentinel lymph nodes located by this technique in predicting the status of lateral lymph nodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinel Lymph Node Biopsy | Experimental | Procedure: Sentinel lymph node biopsy, Drug: Indocyanine green solution, Device: fluorescence laparoscope, Diagnostic Test: pathological examination, Diagnostic Test: rapid frozen pathological examination, Procedure: total mesorectal excisionThe fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 to 75 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
- Newly diagnosed patients with confirmed rectal cancer by histopathology.
- Preoperative clinical staging by imaging examination is T3-4.
- Preoperative colonoscopy shows the distance from the tumor's lower edge to the anus is less than 10cm.
Key exclusion criteria (11 listed)
- Complete intestinal obstruction.
- Active hepatitis and peripheral neuropathy (such as peripheral neuritis, pseudomeningitis, motor neuritis, sensory disturbances, etc.).
- Pregnant or lactating women; women of childbearing potential who have not taken sufficient contraceptive measures.
- History of other tumors or previous chemotherapy or radiotherapy.
- Alcoholism or drug addiction.
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 |
|---|---|---|
| Sentinel lymph node biopsyAlso: Lateral lymph nodes dissectionAfter the total mesorectal excision, the indocyanine green was injected around the tumor via the anus. The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed and sent for rapid frozen pathological examination. Subsequently, a lateral lymph node dissection was performed. | Procedure or surgery | Sentinel Lymph Node Biopsy |
| Indocyanine green solutionAlso: Indocyanine green fluorescence imagingIndocyanine green was injected around the tumor via the anus to visualize the sentinel lymph nodes under the fluorescence laparoscope. | Drug | Sentinel Lymph Node Biopsy |
| fluorescence laparoscopeThe fluorescence laparoscope was used to visualize and locate the sentinel lymph node. | Device | Sentinel Lymph Node Biopsy |
| pathological examinationThe surgical specimens and sentinel lymph nodes were routinely examined for pathology. | Diagnostic test | Sentinel Lymph Node Biopsy |
| rapid frozen pathological examinationThe lateral green fluorescence imaging sentinel lymph nodes found during surgery was sent to make cryosections. And then a pathologist makes a rapid diagnosis under a microscope。 | Diagnostic test | Sentinel Lymph Node Biopsy |
| total mesorectal excisionAlso: TME1. Sharply dissect the vascular interface between the pelvic fascia parietal layer and the visceral layer around the mesentery under direct vision to ensure that the rectal mesentery of the resected specimen is intact and tearless. 2. For medium and low rectal cancer: the distal intestinal tube of the tumor should be resected ≥ 2 cm. 3. TME or mesenteric distal resection margin ≥ 5 cm away from the tumor. | Procedure or surgery | Sentinel Lymph Node Biopsy |
Primary outcome
False negative rate
Time frame: up to 14 days
The false negative rate of predicting lateral lymph node metastasis status using rapid frozen pathology results of lateral sentinel lymph nodes in mid-to-low rectal cancer. Namely, the false negative rate= total false negative cases/(total false negative cases+total true positive cases).
Accuracy
Time frame: up to 14 days
The accuracy of predicting lateral lymph node metastasis status using rapid frozen pathology results of lateral sentinel lymph nodes in mid-to-low rectal cancer. Namely, the accuracy = (total true negative cases+total true positive cases)/total number of cases.
3 secondary outcomes
Detection rate
Time frame: up to 14 days
Specificity
Time frame: up to 14 days
Sensitivity
Time frame: up to 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No. Participants' data are only allowed to be used for the analysis of this study and are not authorized to be shared with other researchers.
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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.
Haitao Zhou, M.D. study chair
National Cancer Center, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel lymph node biopsy, Indocyanine green solution and fluorescence laparoscope in people with Rectal Cancer Stage III and Rectal Cancer Stage IV, run by National Cancer Center, China 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: status not confirmed, as of the sponsor's last update on 28 Apr 2023. 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 Yueyang Zhang, M.D. (+8613552910035, yyzhang0129@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False negative rate (time frame: up to 14 days). The study lists 2 primary outcomes in all. 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 28 Apr 2023.