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Not yet recruiting NCT05730595

Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer

No phase Interventional Colorectal Neoplasms Fluorescence Lymph Node Excision

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lymph node dissection.
Who it may be relevant to
Registry conditions: Colorectal Neoplasms, Fluorescence, Lymph Node Excision. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Procedure lymph node dissection
    The extent of lymph node dissection varies between groups

Primary outcome measures

  • Disease-free survival [Time frame: The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 36 months.]
  • Overall survival [Time frame: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 36 months.]
Secondary outcome measures (5)
  • The number of lymph node resection [Time frame: Until the pathological result is available , an average of 14 days.]
  • Blood loss [Time frame: Until the end of the operation, an average of 8 hours.]
  • Complications [Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.]
  • Hospital stay after surgery [Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.]
  • Function score [Time frame: Until one year after the patient's surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 19 centers
  • The First Affiliated Hospital of University of Science and Technology of China — Hefei
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing
  • The First Affiliated Hospital of Chengdu Medical College — Chengdu
  • Fujian Province Tumor Hospital — Fuzhou
  • Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou
  • Guangdong Provincial People's Hospital — Guangzhou
  • Nanfang Hospital of Southern Medical University — Guangzhou
  • Hebei Medical University Fourth Hospital — Shijiazhuang
  • … and 11 more centers

Identifiers

NCT: NCT05730595 · NCC20231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗