Rectal Carcinoma Clinical Trial
Official title:
Indocanine Green as Tracer for Lymph Nodes Dissection in Station 253 of Rectal and Sigmoid Colon Carcinoma
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University |
China,
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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