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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Enrolling

Conditions: Lymph Node Cancer Metastatic; Rectal Cancer

Treatments: Procedure: ICG-guided lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05873621

279/20

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

ICG-guided lymphadenectomy

Experimental group

Description:

Patients will intraoperatively receive a transanal local administration of ICG. During laparoscopic total mesorectal excision, ICG-fluorescent lymph nodes beyond the mesorectum will be separately excised and sent for pathology

Treatment:

Procedure: ICG-guided lymphadenectomy