Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
87 participants
INTERVENTIONAL
2023-05-31
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Sentinel Lymph Node Biopsy
The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.
Sentinel lymph node biopsy
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 solution
Indocyanine green was injected around the tumor via the anus to visualize the sentinel lymph nodes under the fluorescence laparoscope.
fluorescence laparoscope
The fluorescence laparoscope was used to visualize and locate the sentinel lymph node.
pathological examination
The surgical specimens and sentinel lymph nodes were routinely examined for pathology.
rapid frozen pathological examination
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 excision
1. 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.
Interventions
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Sentinel lymph node biopsy
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 solution
Indocyanine green was injected around the tumor via the anus to visualize the sentinel lymph nodes under the fluorescence laparoscope.
fluorescence laparoscope
The fluorescence laparoscope was used to visualize and locate the sentinel lymph node.
pathological examination
The surgical specimens and sentinel lymph nodes were routinely examined for pathology.
rapid frozen pathological examination
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 excision
1. 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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
18 Years
75 Years
ALL
No
Sponsors
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National Cancer Center, China
OTHER
Responsible Party
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Haitao Zhou
Clinical Professor
Principal Investigators
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Haitao Zhou, M.D.
Role: STUDY_CHAIR
National Cancer Center, China
Locations
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National Cancer Center
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SLNB
Identifier Type: -
Identifier Source: org_study_id
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