Clinical Application of Carbon Nanoparticles in Lymph Node Tracing and Surgery Guiding of Colorectal Cancer

NCT06783985 | Completed DMC

• 1 other identifier: SirRRSH-CNP-CRC
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

This trial aims to clarify the relationship between carbon nanoparticles labeled lymph nodes and lymph node metastasis in different lymph node regions of colorectal cancer, and to clarify the application value of carbon nanoparticles in lymph node dissection in colorectal cancer surgery.

Conditions

Colorectal Cancer

Keywords

carbon nanoparticle; colorectal cancer; lymph node

Outcome Measures

Primary Outcomes (1)

• The relationship between carbon nanoparticle stained lymph nodes and metastatic lymph nodes

  From enrollment to the pathology report at 2 weeks

Secondary Outcomes (1)

• Carbon nanoparticle stained lymph nodes from different lymph node groups.

  From enrollment to the pathology report at 2 weeks

Study Arms (1)

CNP group

Every patient received endoscopic injection of 0.5 ml CNP suspension (Chongqing LUMMY Pharmaceutical Co., Chongqing, China) into submucosal layer at one point, at the lower margin of the tumor. All patients subsequently underwent laparoscopic or robotic radical resection with D3 LN dissection. Tumor tissue and LNs s were isolated from surgical specimen by the same pathologist. LNs dissection and harvest were on the basis of the Japanese classification of colorectal carcinoma.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was conducted in Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. Patient information and samples were obtained from patients undergoing radical resection of colorectal cancer in the colorectal surgery department of the hospital.

You may qualify if:

• a diagnosis of colorectal cancer;
• endoscopic injection of CNP suspension preoperatively
• planned radical resection of colorectal cancer
• older than 18 years of age

You may not qualify if:

• (a) emergency surgery;

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 20, 2025
• Study Start: March 16, 2022
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)