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

May 15, 2023 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:
        • Principal Investigator:
          • Luca Sorrentino, MD
        • Principal Investigator:
          • Maurizio Cosimelli, MD
        • Sub-Investigator:
          • Luigi Battaglia, MD
        • Sub-Investigator:
          • Marcello Guaglio, MD
        • Sub-Investigator:
          • Gaia Colletti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total number of harvested lymph nodes
Time Frame: 15 days
15 days
Number of harvested extra-mesorectal lymph nodes
Time Frame: 15 days
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraoperative and postoperative complications rates
Time Frame: 15 days
15 days
Time of surgery
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

  • Principal Investigator: Maurizio Cosimelli, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 279/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe