Indocanine Green as Tracer for Lymph Nodes Dissection in Station 253

Rectal Carcinoma Clinical Trial

Official title:

Indocanine Green as Tracer for Lymph Nodes Dissection in Station 253 of Rectal and Sigmoid Colon Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04848311
• Other study ID #: NFEC-2021-073
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: December 2020
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jun Yan, M.D,Ph.D
• Phone: 13825066546
• Email: yanjunfudan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized controlled study. investigators will randomly assign patients to the indocanine green (ICG) group and control (CL)group to compare the differences of lymph nodes dissection in station 253 between the two groups.

Description:

ICG is a registered and FDA-approved non-specific fluorescent probe for optical imaging in clinical settings. The properties of ICG ,which is a water-soluble amphiphilic molecule with a molecular weight of 775 Dalton and a hydrodynamic diameter of 1.2nm ,render it an excellent lymphatic contrast agents if injected into the lymphatic system. ICG near-infrared(NIR) fluorescent imaging has achieved satisfactory results in the localization of sentinel lymph nodes in patients with breast cancer,non-small cell lung cancer,and gastric cancer. Liang et al have suggested that 253 lymph nodes dissection in rectal cancer is technically demanding ,and that learning curve for laparoscopic 253 lymph nodes dissection requires minimally 20 procedures. Currently,it was still controversial about 253 lymph nodes dissection in rectal cancer surgery. However, lymph node involvement is a major prognostic factor for survival after rectal cancer surgery. Therefore, it is necessary to harvest more station 253 nodes for the better long-term survival and the more precise staging.

In this study, investigators will randomly assign patients to the indocanine green (ICG) group and control (CL)group. Number of harvested station 253 lymph nodes, number of positive station 253 lymph nodes, will be evaluated and compared. Investigators will also evaluate patients, operative time, blood loss, post-operative hospital stay and complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

(1)18-80 years of age (2)American Society of Anesthesiologists (ASA) class 1-3 (3)single rectal or sigmoid colon carcinoma confirmed pathologically by endoscopic biopsy (4)planned laparoscopic radical resection (5)Written informed consent

Exclusion Criteria:

1. previous abdominal tumor surgery

2. women who are pregnant or breast feeding

3. emergency patients with obstruction or perforation

4. T4b cancer evaluated by CT or MRI or endoscopic ultrasonography

5. pelvic or distant metastasis

6. T1 cancer planned local excision

7. allergic constitution patients

Related Conditions & MeSH terms

• Carcinoma
• Colonic Neoplasms
• Rectal Carcinoma
• Sigmoid Colon Carcinoma

Intervention

Procedure:
• lymph nodes dissection at 253 station assisted by ICG
In ICG group :All patients will be subjected to laparoscopic radical resection with station 253 lymph nodes dissection by fluorescence laparoscopic.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	operative time		intraoperative
Other	post-operative data	blood loss	one hour after operation
Other	post-operative hospital stay	post-operative hospital stay	two weeks after operation
Other	complications	post-operative data	two weeks after operation
Primary	number of harvested station 253 lymph nodes	number of harvested station 253 lymph nodes,number of positive station 253 lymph nodes,rate of positive station 253 lymph nodes	one week after operation
Secondary	number of harvested station 251 lymph nodes	number of harvested station 251 lymph nodes, number of positive station 251 lymph nodes, rate of positive station 251 lymph nodes,	one week after operation
Secondary	number of harvested station 252 lymph nodes	number of harvested station 252 lymph nodes, number of positive station 252 lymph nodes , rate of positive station 252 lymph nodes	one week after operation
Secondary	number of total lymph nodes harvested	number of total lymph nodes harvested, number of total positive lymph nodes ,rate of total positive lymph nodes	one week after operation