Sentinel Lymph Node Biopsy in Rectal Cancer

NCT05830890 | Unknown

• 1 other identifier: SLNB
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer Stage III; Rectal Cancer Stage IV

Keywords

Laparoscope; Rectal cancer; Indocyanine green; Sentinel lymph node; lymph node dissection

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  up to 14 days

Secondary Outcomes (3)

• Detection rate

  up to 14 days

• Specificity

  up to 14 days

• Sensitivity

  up to 14 days

Study Arms (1)

Sentinel Lymph Node Biopsy

EXPERIMENTAL

The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.

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

Interventions

Sentinel lymph node biopsy PROCEDURE

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.

Also known as: Lateral lymph nodes dissection

Sentinel Lymph Node Biopsy

Indocyanine green solution DRUG

Indocyanine green was injected around the tumor via the anus to visualize the sentinel lymph nodes under the fluorescence laparoscope.

Also known as: Indocyanine green fluorescence imaging

Sentinel Lymph Node Biopsy

fluorescence laparoscope DEVICE

The fluorescence laparoscope was used to visualize and locate the sentinel lymph node.

Sentinel Lymph Node Biopsy

pathological examination DIAGNOSTIC_TEST

The surgical specimens and sentinel lymph nodes were routinely examined for pathology.

Sentinel Lymph Node Biopsy

rapid frozen pathological examination DIAGNOSTIC_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。

Sentinel Lymph Node Biopsy

total mesorectal excision PROCEDURE

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.

Also known as: TME

Sentinel Lymph Node Biopsy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, China: lead

Study Sites (1)

National Cancer Center

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Haitao Zhou, M.D.

  National Cancer Center, China

  STUDY CHAIR

Central Study Contacts

Yueyang Zhang, M.D.

CONTACT

+8613552910035; yyzhang0129@163.com

Zheng Xu, M.D.

CONTACT

+8613141127297; 840677252@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 26, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)