NCT05873621

Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer
• Lymph Node Cancer Metastatic

Interventions

Type	Name	Description
PROCEDURE	ICG-guided lymphadenectomy	Excision of ICG-fluorescent lymph nodes in addition to standard laparoscopic total mesorectal excision in rectal cancer patients after neoadjuvant chemoradiation

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-09-30
• Completion: 2023-12-30
• First posted: 2023-05-24
• Last updated: 2023-05-24

Locations

1 site across 1 country: Italy