NCT05830890

Sentinel Lymph Node Biopsy in Rectal Cancer

A Clinical Trial of Sentinel Lymph Node Biopsy in Rectal Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: National Cancer Center, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer Stage III
• Rectal Cancer Stage IV

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	Indocyanine green solution	Indocyanine green was injected around the tumor via the anus to visualize the sentinel lymph nodes under the fluorescence laparoscope.
DEVICE	fluorescence laparoscope	The fluorescence laparoscope was used to visualize and locate the sentinel lymph node.
DIAGNOSTIC_TEST	pathological examination	The surgical specimens and sentinel lymph nodes were routinely examined for pathology.
DIAGNOSTIC_TEST	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。
PROCEDURE	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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-04-26
• Last updated: 2023-04-28

Locations

1 site across 1 country: China