Rectal Cancer(GreenEye-CRC)NCT05873621
Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy
A study testing ICG-guided lymphadenectomy in people with Rectal Cancer and Lymph Node Cancer Metastatic, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rectal Cancer, Lymph Node Cancer Metastatic
- What is being tested?
- ICG-guided lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low or middle rectal adenocarcinoma
- Indication for sphincter-saving surgery
- Neoadjuvant chemoradiation
- Indication for laparoscopic surgery
- Signed informed consent
Who cannot join
- Distant metastases at diagnosis, included peritoneal carcinomatosis
- Squamous cell cancer
- Allergy to indocyanine green
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Luca Sorrentino, MD, +39 0223902578, luca.sorrentino@istitutotumori.mi.it
Luca Sorrentino, MD
About this study
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.
- Conditions
- Rectal Cancer, Lymph Node Cancer Metastatic
- Being tested
- ICG-guided lymphadenectomy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-guided lymphadenectomyProcedure or surgery
Excision of ICG-fluorescent lymph nodes in addition to standard laparoscopic total mesorectal excision in rectal cancer patients after neoadjuvant chemoradiation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: ICG-guided lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of harvested lymph nodes
Measured: 15 days
Number of harvested extra-mesorectal lymph nodes
Measured: 15 days
Secondary outcomes (2)
Intraoperative and postoperative complications rates
Measured: 15 days
Time of surgery
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jan 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurizio Cosimelli, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873621
- Sponsor's protocol ID
- 279/20
- Acronym
- (GreenEye-CRC)
- Status last verified
- Jan 2023
- First submitted
- 4 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34953173
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05873621
- Acronym / sponsor ID
- (GreenEye-CRC) / 279/20
- Conditions
- Rectal Cancer, Lymph Node Cancer Metastatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG-guided lymphadenectomy | Experimental | Procedure: ICG-guided lymphadenectomyPatients 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Low or middle rectal adenocarcinoma
- Indication for sphincter-saving surgery
- Neoadjuvant chemoradiation
- Indication for laparoscopic surgery
- Signed informed consent
Key exclusion criteria (3 listed)
- Distant metastases at diagnosis, included peritoneal carcinomatosis
- Squamous cell cancer
- Allergy to indocyanine green
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG-guided lymphadenectomyExcision of ICG-fluorescent lymph nodes in addition to standard laparoscopic total mesorectal excision in rectal cancer patients after neoadjuvant chemoradiation | Procedure or surgery | ICG-guided lymphadenectomy |
Primary outcome
Total number of harvested lymph nodes
Time frame: 15 days
Number of harvested extra-mesorectal lymph nodes
Time frame: 15 days
2 secondary outcomes
Intraoperative and postoperative complications rates
Time frame: 15 days
Time of surgery
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Background: PubMed 34953173Colletti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Cosimelli, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG-guided lymphadenectomy in people with Rectal Cancer and Lymph Node Cancer Metastatic, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Sorrentino, MD (+39 0223902578, luca.sorrentino@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of harvested lymph nodes (time frame: 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05873621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.