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

Not Applicable

Recruiting

• Conditions: Lymph Node Cancer Metastatic; Rectal Cancer
• Interventions: Procedure: ICG-guided lymphadenectomy

• Registration Number: NCT05873621
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-01
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-15
• Last Update Submitted: 2023-05-15
• Study First Posted: 2023-05-24
• Last Update Posted: 2023-05-24
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICG-guided lymphadenectomy	ICG-guided lymphadenectomy	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

Primary Outcome Measures

Name	Time	Method
Total number of harvested lymph nodes	15 days
Number of harvested extra-mesorectal lymph nodes	15 days

Secondary Outcome Measures

Name	Time	Method
Intraoperative and postoperative complications rates	15 days
Time of surgery	15 days

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy