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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
66
In ICG group :All patients will be subjected to laparoscopic radical resection with station 253 lymph nodes dissection by fluorescence laparoscopic.
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGnumber 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
Time frame: one week after operation
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,
Time frame: one week after operation
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
Time frame: one week after operation
number of total lymph nodes harvested
number of total lymph nodes harvested, number of total positive lymph nodes ,rate of total positive lymph nodes
Time frame: one week after operation
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