Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer (FLORA-01)

A Randomized Controlled Trial of Fluorescence Laparoscopic Navigation of the Extent of Lymph Node Dissection for High 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms; Fluorescence; Lymph Node Excision
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianqiang Tang, Dr.; Phone Number: +8613661090036; Email: doc_tjq@hotmail.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • The First Affiliated Hospital of University of Science and Technology of China
      • Contact: Hanhui Yao, Dr.; Phone Number: 13505698955
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
  • Chengdu
    • Chengdu, Chengdu, China, 610500
      • The First Affiliated Hospital of Chengdu Medical College
      • Contact: Jiangwei Xiao, Dr.; Phone Number: 17311394528
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Province Tumor Hospital
      • Contact: Chunkang Yang, Dr.; Phone Number: 13509333116
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangdong Provincial Hospital of Traditional Chinese Medicine
      • Contact: Dechang Diao
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University
      • Contact: Haijun Deng, Dr.; Phone Number: 13189096629
    • Guangzhou, Guangdong, China, 510320
      • Guangdong Provincial People's Hospital
      • Contact: Deqing Wu, Dr.; Phone Number: 13902301120
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Hebei Medical University Fourth Hospital
  • Heilongjiang
    • Haerbin, Heilongjiang, China, 150001
      • The Second Affiliated Hospital of Harbin Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
      • Contact: Hao Wang, Dr.; Phone Number: 18602513286
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Provincial Cancer Hospital
      • Contact: Bo Yi, Dr.; Phone Number: 13517007527
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
      • Contact: Quan Wang, Dr.; Phone Number: 13944810508
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital
      • Contact: Hong Zhang, Dr.; Phone Number: 18940257919
  • Qinghai
    • Xining, Qinghai, China, 810001
      • Qinghai University Affiliated Hospital
      • Contact: Su Yan, Dr.; Phone Number: 13519768807
  • Shandong
    • Binzhou, Shandong, China, 256603
      • Binzhou Medical University
      • Contact: Hong Jiang, Dr.; Phone Number: 155 6436 6177
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
      • Contact: Guoxiang Cai, Dr.; Phone Number: 13611831623
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Shanxi Cancer Hospital
      • Contact: Haiyi Liu, Dr.; Phone Number: 15802513619
  • Sichuan
    • Yibin, Sichuan, China, 644000
      • The Second People's Hospital of Yibin
      • Contact: Miao Wu, Dr.; Phone Number: 13990905852
  • Yunnan
    • Kunming, Yunnan, China, 650021
      • The Second People's Hospital of Yunnan Province
      • Contact: Bo Li, Dr.; Phone Number: 137 0847 2035

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D2 lymph node dissection; The D2 lymph node region are dissected. And 1-3 lymph nodes of the D2 region will be selected for intraoperative frozen section. If no lymph node metastasis is found in freezing, the D3 region lymph nodes in the root of the submesenteric artery were preserved.	Procedure: lymph node dissection; The extent of lymph node dissection varies between groups; Other Names: Fluorescence-guided laparoscopic surgery; Radical operation for rectal cancer and sigmoid Cancer
Active Comparator: D3 lymph node dissection; Thorough dissection of lymph nodes in the D3 region.	Procedure: lymph node dissection; The extent of lymph node dissection varies between groups; Other Names: Fluorescence-guided laparoscopic surgery; Radical operation for rectal cancer and sigmoid Cancer

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure	Measure Description	Time Frame
Blood loss	Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).	Until the end of the operation, an average of 8 hours.
Complications	Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.	Until the patient recovered and was discharged from the hospital, an average of 10 days.
The number of lymph node resection	The number of lymph nodes removed during surgery, which is obtained by postoperative pathological results	Until the pathological result is available , an average of 14 days.
Hospital stay after surgery	Hospital stay after surgery is defined as the length of time from the end of surgery	Until the patient recovered and was discharged from the hospital, an average of 10 days.
Function score	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.	Until one year after the patient's surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 26, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal cancer; Lymph node dissection; Fluorescence laparoscopic navigation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Sigmoid Diseases; Colonic Neoplasms; Colorectal Neoplasms; Sigmoid Neoplasms
• Other Study ID Numbers: NCC20231

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No