Clinical Application of Carbon Nanoparticles in Lymph Node Tracing and Surgery Guiding of Colorectal Cancer (CNP-CRC)

January 16, 2025 updated by: Bingjun Bai, Sir Run Run Shaw Hospital

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.

Study Overview

Status

Completed

Conditions

Colorectal Cancer

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Zhejiang
  - Hangzhou, Zhejiang, China
    - Sir Run Run Shaw Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

(a) emergency surgery;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The relationship between carbon nanoparticle stained lymph nodes and metastatic lymph nodes Time Frame: From enrollment to the pathology report at 2 weeks	From enrollment to the pathology report at 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Carbon nanoparticle stained lymph nodes from different lymph node groups. Time Frame: From enrollment to the pathology report at 2 weeks	From enrollment to the pathology report at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Run Run Shaw Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2022

Primary Completion (Actual)

April 20, 2024

Study Completion (Actual)

April 20, 2024

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)