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Trial Title:
Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy
NCT ID:
NCT05873621
Condition:
Rectal Cancer
Lymph Node Cancer Metastatic
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
ICG-guided lymphadenectomy
Description:
Excision of ICG-fluorescent lymph nodes in addition to standard laparoscopic total
mesorectal excision in rectal cancer patients after neoadjuvant chemoradiation
Arm group label:
ICG-guided lymphadenectomy
Summary:
The goal of this clinical trial is to assess the number of harvested locoregional lymph
nodes in rectal cancer patients undergoing laparoscopic total mesorectal excision and
indocyanine green (ICG)-guided lymphoadenectomy after neoadjuvant chemoradiation. The
main questions it aims to answer are:
- Does the use of ICG increase the total number of harvested lymph nodes?
- Does the use of ICG increase the number of harvested extra-mesorectal lymph nodes?
Participants will intraoperatively receive a trans-anal administration of ICG near to
rectal cancer; during laparoscopic surgery, ICG-fluorescent nodes beyond the mesorectum
will be separately excised and sent for pathology. A comparison will be performed with a
recent cohort of patients affected by rectal cancer treated with standard surgery without
the use of ICG.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Low or middle rectal adenocarcinoma
- Indication for sphincter-saving surgery
- Neoadjuvant chemoradiation
- Indication for laparoscopic surgery
- Signed informed consent
Exclusion Criteria:
- Distant metastases at diagnosis, included peritoneal carcinomatosis
- Squamous cell cancer
- Allergy to indocyanine green
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milan
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luca Sorrentino, MD
Phone:
+39 0223902578
Email:
luca.sorrentino@istitutotumori.mi.it
Investigator:
Last name:
Luca Sorrentino, MD
Email:
Principal Investigator
Investigator:
Last name:
Maurizio Cosimelli, MD
Email:
Principal Investigator
Investigator:
Last name:
Luigi Battaglia, MD
Email:
Sub-Investigator
Investigator:
Last name:
Marcello Guaglio, MD
Email:
Sub-Investigator
Investigator:
Last name:
Gaia Colletti, MD
Email:
Sub-Investigator
Start date:
January 1, 2023
Completion date:
December 30, 2023
Lead sponsor:
Agency:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Agency class:
Other
Source:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05873621
