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

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05730595
• Collaborator: Fudan University (Other), Fujian Province Tumor Hospital (Other), Guangdong Provincial People's Hospital (Other), Shengjing Hospital (Other), Affiliated Hospital of Qinghai University (Other), Hebei Medical University Fourth Hospital (Other), The Second Affiliated Hospital of Harbin Medical University (Other), Jiangxi Provincial Cancer Hospital (Other), The First Hospital of Jilin University (Other), Guangdong Provincial Hospital of Traditional Chinese Medicine (Other), Shanxi Province Cancer Hospital (Other), Nanfang Hospital of Southern Medical University (Other), Second People's Hospital of Yunnan Province (Other), Binzhou Medical University (Other), The First Affiliated Hospital of University of Science and Technology of China (Other), First Affiliated Hospital of Chengdu Medical College (Other), The Second People's Hospital of Yibin (Other), The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
• Enrollment: 550
• Locations: 19
• Arms: 2
• Anticipated Duration (Months): 51
• Patients Per Site: 28.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms; Fluorescence; Lymph Node Excision	Procedure: lymph node dissection	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 550 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Jun 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Disease-free survival [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 [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 Outcome Measures

1. The number of lymph node resection [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui	China	230001
2	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing	China	100021
3	The First Affiliated Hospital of Chengdu Medical College	Chengdu	Chengdu	China	610500
4	Fujian Province Tumor Hospital	Fuzhou	Fujian	China	350014
5	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong	China	510120
6	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510320
7	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong	China	510515
8	Hebei Medical University Fourth Hospital	Shijiazhuang	Hebei	China	050000
9	The Second Affiliated Hospital of Harbin Medical University	Haerbin	Heilongjiang	China	150001
10	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008
11	Jiangxi Provincial Cancer Hospital	Nanchang	Jiangxi	China	330029
12	The First Hospital of Jilin University	Changchun	Jilin	China	130021
13	Shengjing Hospital	Shenyang	Liaoning	China	110004
14	Qinghai University Affiliated Hospital	Xining	Qinghai	China	810001
15	Binzhou Medical University	Binzhou	Shandong	China	256603
16	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032
17	Shanxi Cancer Hospital	Taiyuan	Shanxi	China	030013
18	The Second People's Hospital of Yibin	Yibin	Sichuan	China	644000
19	The second People's Hospital of Yunnan Province	Kunming	Yunnan	China	650021

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianqiang Tang, Associate professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT05730595
• Other Study ID Numbers: NCC20231
• First Posted: Feb 16, 2023
• Last Update Posted: Feb 22, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jianqiang Tang, Associate professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences: Colorectal cancer; Fluorescence laparoscopic navigation; Lymph node dissection
• Additional relevant MeSH terms: Colorectal Neoplasms; Sigmoid Neoplasms

Study Results

No Results Posted as of Feb 22, 2023