Back to resultsIndocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy ((GreenEye-CRC))
Primary Purpose
Rectal Cancer, Lymph Node Cancer Metastatic
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ICG-guided lymphadenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
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
Sites / Locations
- Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ICG-guided lymphadenectomy
Arm 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
Outcomes
Primary Outcome Measures
Total number of harvested lymph nodes
Number of harvested extra-mesorectal lymph nodes
Secondary Outcome Measures
Intraoperative and postoperative complications rates
Time of surgery
Full Information
NCT ID
NCT05873621
First Posted
May 4, 2023
Last Updated
May 15, 2023
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1. Study Identification
Unique Protocol Identification Number
NCT05873621
Brief Title
Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy
Acronym
(GreenEye-CRC)
Official Title
Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Lymph Node Cancer Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICG-guided lymphadenectomy
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
ICG-guided lymphadenectomy
Intervention Description
Excision of ICG-fluorescent lymph nodes in addition to standard laparoscopic total mesorectal excision in rectal cancer patients after neoadjuvant chemoradiation
Primary Outcome Measure Information:
Title
Total number of harvested lymph nodes
Time Frame
15 days
Title
Number of harvested extra-mesorectal lymph nodes
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Intraoperative and postoperative complications rates
Time Frame
15 days
Title
Time of surgery
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Sorrentino, MD
Phone
+39 0223902578
Email
luca.sorrentino@istitutotumori.mi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Cosimelli, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Sorrentino, MD
Phone
+39 0223902578
Email
luca.sorrentino@istitutotumori.mi.it
First Name & Middle Initial & Last Name & Degree
Luca Sorrentino, MD
First Name & Middle Initial & Last Name & Degree
Maurizio Cosimelli, MD
First Name & Middle Initial & Last Name & Degree
Luigi Battaglia, MD
First Name & Middle Initial & Last Name & Degree
Marcello Guaglio, MD
First Name & Middle Initial & Last Name & Degree
Gaia Colletti, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34953173
Citation
Colletti G, Battaglia L, Sorrentino L, Guaglio M, Cosimelli M. Indocyanine green-guided lymphadenectomy of the inferior mesenteric artery in laparoscopic total mesorectal excision for low rectal cancer after neoadjuvant chemoradiotherapy - A Video Vignette. Colorectal Dis. 2022 Apr;24(4):547. doi: 10.1111/codi.16031. Epub 2022 Jan 6. No abstract available.
Results Reference
background
Learn more about this trial
Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy
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