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ClinicalTrials.gov ID

NCT05730595

Lead Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical SciencesOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

550Estimated

Last Update Posted

Aug 29, 2023Actual

Start Date

Sep 1, 2023Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Jun 1, 2027Estimated

Official Title

A Randomized Controlled Trial of Fluorescence Laparoscopic Navigation of the Extent of Lymph Node Dissection for High Rectal Cancer and Sigmoid Colon Cancer

Brief Summary

To explore the short-term and long-term outcomes of fluorescence laparoscopic navigation D2 lymph node dissection for colorectal cancer surgery by comparing it with D3 lymph node dissection.

Detailed Description

Lymph node metastasis is the most common metastatic mechanisms for colorectal cancer. Therefore, regional lymph node dissection is the key part in radical surgery for colorectal cancer. In patients who have developed lymph node metastases, inadequate lymph node dissection will promote tumor recurrence. In patients who do not develop lymph node metastases, excessive lymph node dissection not only does not improve the patient's prognosis, but also increases surgical trauma and destroys the antitumor effect of the lymphoid immune system. There is still some controversy over whether to choose D3 lymph node dissection or D2 lymph node dissection for rectal and sigmoid cancer. Fluorescence laparoscopic navigation techniques can guide lymph node dissection by visualizing lymph nodes more clearly during surgery.

This study will compare the short-term and long-term oncological outcomes between fluorescence laparoscopic navigation D2 and D3 lymph node dissection by conducting a randomized controlled trial.

• Colorectal Neoplasms
• Fluorescence
• Lymph Node Excision

• lymph node dissection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Participants are aged 18-75;
• Colonoscopy biopsy confirms colorectal adenocarcinoma;
• Colonoscopy shows that the lower edge of the tumor is located more than 10 cm from the margin or the tumor is located in the upper rectum and sigmoid colon by imaging diagnosis;
• The tumor is staged cT1-4aNxM0 by preoperative imaging;
• Participants have no local complications before surgery.

Exclusion Criteria:

• Previous history of malignant colorectal tumor;
• Multiple primary colorectal tumors;
• Preoperative imaging reveals suspicious positive lymph nodes in the submesenteric artery root region (area 253);
• Patients undergoing neoadjuvant therapy before surgery;
• With contraindications to laparoscopic surgery;
• Histoty of multiple abdominal and pelvic surgery or extensive abdominal adhesions;
• Other malignancies were diagnosed within the past 5 years;
• History of severe mental illness;
• Pregnant or lactating women;
• With uncontrolled infection before surgery.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical SciencesOTHER

Collaborators

Fudan UniversityOTHER

Fujian Province Tumor HospitalOTHER

Guangdong Provincial People's HospitalOTHER

Shengjing HospitalOTHER

Affiliated Hospital of Qinghai UniversityOTHER

Hebei Medical University Fourth HospitalOTHER

The Second Affiliated Hospital of Harbin Medical UniversityOTHER

Jiangxi Provincial Cancer HospitalOTHER

The First Hospital of Jilin UniversityOTHER

Guangdong Provincial Hospital of Traditional Chinese MedicineOTHER

Shanxi Province Cancer HospitalOTHER

Nanfang Hospital, Southern Medical UniversityOTHER

Second People's Hospital of Yunnan ProvinceOTHER

Binzhou Medical UniversityOTHER

The First Affiliated Hospital of University of Science and Technology of ChinaOTHER

First Affiliated Hospital of Chengdu Medical CollegeOTHER

The Second People's Hospital of YibinOTHER

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolOTHER

13509333116

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