Sentinel Lymph Node Biopsy in Rectal Cancer

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.

Conditions

• Rectal Cancer Stage III
• Rectal Cancer Stage IV

Interventions

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.

Sponsors & Collaborators

• National Cancer Center, China

  lead OTHER

Principal Investigators

• Haitao Zhou, M.D. · National Cancer Center, China

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-31

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• China

Study Locations