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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04848311
Other study ID # NFEC-2021-073
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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