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NCT Number: NCT05730595

Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lymph Node Dissection

Procedure

The extent of lymph node dissection varies between groups

Other names: Fluorescence-guided laparoscopic surgery, Radical operation for rectal cancer and sigmoid Cancer

Primary outcomes

  1. 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.

    Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months.

  2. 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.

    Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.

Secondary outcomes

  1. The number of lymph node resection

    Time frame: Until the pathological result is available , an average of 14 days.

    The number of lymph nodes removed during surgery, which is obtained by postoperative pathological results

  2. Blood loss

    Time frame: Until the end of the operation, an average of 8 hours.

    Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).

  3. Complications

    Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.

    Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.

  4. Hospital stay after surgery

    Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.

    Hospital stay after surgery is defined as the length of time from the end of surgery

  5. Function score

    Time frame: Until one year after the patient's surgery

    Function score includes International Prostate Symptom Score, low anterior resection syndrome score and International Index of Erectile Function-5 score, which are used for assess the physical function.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianqiang Tang, Dr.

CONTACT

[email protected]

+8613661090036

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Collaborators

  • Affiliated Hospital of Qinghai University
  • Binzhou Medical University
  • First Affiliated Hospital of Chengdu Medical College
  • Fudan University
  • Fujian Province Tumor Hospital
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Guangdong Provincial People's Hospital
  • Hebei Medical University Fourth Hospital
  • Jiangxi Provincial Cancer Hospital
  • Nanfang Hospital, Southern Medical University
  • Second People's Hospital of Yunnan Province
  • Shanxi Province Cancer Hospital
  • Shengjing Hospital
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The First Affiliated Hospital of University of Science and Technology of China
  • The First Hospital of Jilin University
  • The Second Affiliated Hospital of Harbin Medical University
  • The Second People's Hospital of Yibin

Registry information

Official study title

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

Acronym: FLORA-01

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 16, 2023
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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