Sentinel Lymph Node Biopsy in Rectal Cancer

A Clinical Trial of Sentinel Lymph Node Biopsy in Rectal Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer Stage III; Rectal Cancer Stage IV
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 87
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueyang Zhang, M.D.; Phone Number: +8613552910035; Email: yyzhang0129@163.com
• Study Contact Backup: Name: Zheng Xu, M.D.; Phone Number: +8613141127297; Email: 840677252@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • National Cancer Center
      • Contact: Yueyang Zhang, M.D.; Phone Number: +8613552910035; Email: yyzhang0129@163.com
      • Contact: Haitao Zhou, M.D.; Phone Number: +8613381167333; Email: zhouhaitao01745@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sentinel Lymph Node Biopsy; The fluorescence laparoscope was used to visualize and locate the sentinel lymph node, which was then removed.

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.; Other Names: Lateral lymph nodes dissection; Drug: Indocyanine green solution; Indocyanine green was injected around the tumor via the anus to visualize the sentinel lymph nodes under the fluorescence laparoscope.; Other Names: Indocyanine green fluorescence imaging; 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; 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.; For medium and low rectal cancer: the distal intestinal tube of the tumor should be resected ≥ 2 cm.; TME or mesenteric distal resection margin ≥ 5 cm away from the tumor.; Other Names: TME

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate	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.	up to 14 days
Specificity	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).	up to 14 days
Sensitivity	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)。	up to 14 days

Collaborators and Investigators

• Sponsor: National Cancer Center, China
• Investigators: Study Chair: Haitao Zhou, M.D., National Cancer Center, China

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Rectal cancer; lymph node dissection; Indocyanine green; Sentinel lymph node; Laparoscope
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: SLNB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participants' data are only allowed to be used for the analysis of this study and are not authorized to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No