Clinical trial NCT04848311: Indocanine Green as Tracer for Lymph Nodes Dissection in Station 253
Official title: Indocanine Green as Tracer for Lymph Nodes Dissection in Station 253 of Rectal and Sigmoid Colon Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Carcinoma
Sigmoid Colon Carcinoma
Keywords: ICG
253 lymph nodes
rectal carcinoma
sigmoid colon carcinoma
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: number of harvested station 253 lymph nodes
timeFrame: one week after operation
Secondary outcomes:
measure: number of harvested station 251 lymph nodes
timeFrame: one week after operation
measure: number of harvested station 252 lymph nodes
timeFrame: one week after operation
measure: number of total lymph nodes harvested
timeFrame: one week after operation
Other outcomes:
measure: operative time
timeFrame: intraoperative
measure: post-operative data
timeFrame: one hour after operation
measure: post-operative hospital stay
timeFrame: two weeks after operation
measure: complications
timeFrame: two weeks after operation
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jun Yan, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: