NCT05873621

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

May 24, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

May 4, 2023

Last Update Submit

May 15, 2023

Conditions

Rectal CancerLymph Node Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

  • Total number of harvested lymph nodes

    15 days

  • Number of harvested extra-mesorectal lymph nodes

    15 days

Secondary Outcomes (2)

  • Intraoperative and postoperative complications rates

    15 days

  • Time of surgery

    15 days

Study Arms (1)

ICG-guided lymphadenectomy

EXPERIMENTAL

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

Interventions

ICG-guided lymphadenectomyPROCEDURE

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

ICG-guided lymphadenectomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low or middle rectal adenocarcinoma
  • Indication for sphincter-saving surgery
  • Neoadjuvant chemoradiation
  • Indication for laparoscopic surgery
  • Signed informed consent

You may not qualify if:

  • Distant metastases at diagnosis, included peritoneal carcinomatosis
  • Squamous cell cancer
  • Allergy to indocyanine green

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34953173BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Maurizio Cosimelli, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Sorrentino, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 24, 2023

Study Start

January 1, 2023

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

May 24, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)