Sentinel Lymph Node Biopsy in Rectal Cancer

Not Applicable

Not yet recruiting

• Conditions: Rectal Cancer Stage III; Rectal Cancer Stage IV
• Interventions: 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

• Registration Number: NCT05830890
• Lead Sponsor: National Cancer Center, China

Brief 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 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 Timeline

• Study First Submitted: 2023-03-15
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-26
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28
• Study Start: 2023-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• 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.
• 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

• 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.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel Lymph Node Biopsy	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	Indocyanine green solution	The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.
Sentinel Lymph Node Biopsy	pathological examination	The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.
Sentinel Lymph Node Biopsy	rapid frozen pathological examination	The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.
Sentinel Lymph Node Biopsy	total mesorectal excision	The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.
Sentinel Lymph Node Biopsy	fluorescence laparoscope	The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.

Primary Outcome Measures

Name	Time	Method
False negative rate	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	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.

Secondary Outcome Measures

Name	Time	Method
Detection rate	up to 14 days	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.
Sensitivity	up to 14 days	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)。
Specificity	up to 14 days	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).

Trial Locations

Locations (1)

National Cancer Center; 🇨🇳 Beijing, Beijing, China