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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05873621

Acronym

(GreenEye-CRC)

Enrollment

Registered

2023-05-24

Start date

2023-01-01

Completion date

2023-12-30

Last updated

2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymph Node Cancer Metastatic, Rectal Cancer

Brief 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.

Interventions

PROCEDUREICG-guided lymphadenectomy

Excision of ICG-fluorescent lymph nodes in addition to standard laparoscopic total mesorectal excision in rectal cancer patients after neoadjuvant chemoradiation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Total number of harvested lymph nodes	15 days
Number of harvested extra-mesorectal lymph nodes	15 days

Secondary

Measure	Time frame
Intraoperative and postoperative complications rates	15 days
Time of surgery	15 days

Countries

Italy

Contacts

Primary ContactLuca Sorrentino, MD

luca.sorrentino@istitutotumori.mi.it+39 0223902578

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026