Head and Neck CancerNCT03345732
Intraoperative Evaluation Using ICG and SPY Fluorescence to Prevent Wound Complications in Head and Neck Surgery.
An observational study of Head and Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Wound complications, such as salivary-cutaneous fistulas and skin necrosis, result in significant patient morbidity and death. Head and neck wounds are complicated because of multiple tissue layers, critical structures and variable vascularity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- ICG and SPY system for wound complications
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 8 Dec 2016to 31 Oct 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with head and neck cancer requiring surgery.
Who may be able to join
- Adult patients (>18 years old) who are undergoing reconstruction for traumatic or oncologic head and neck wounds
- Specific defects eligible are any pharyngeal, tracheal, or oral cavity defects at risk of devascularized mucosa, or large skin defects requiring skin advancement flaps. This includes laryngectomy/laryngectomy-partial pharyngectomy with primary closure.
- Patient with the above defects that will be having reconstruction with the following donor tissues: local, regional or autogenous free flaps.
- Informed consent
Who cannot join
- Patients who are pregnant or nursing
- Patients with an allergy to iodine (contrast ICG dye contains sodium iodide)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Evaluation Using Indocyanine Green and SPY Fluorescence Angiography to Prevent Wound Complications in Head and Neck Surgery Patients, an Observational Study
Wound complications, such as salivary-cutaneous fistulas and skin necrosis, result in significant patient morbidity and death. Head and neck wounds are complicated because of multiple tissue layers, critical structures and variable vascularity. When vascularity is compromised, wounds do not heal and can lead to life threatening haemorrhage or morbid infections. The field of microsurgical reconstruction has developed and expanded over the last 20 years to specifically ameliorate these issues. The challenge is that the vascularity of the microsurgical transplant or the recipient tissue bed can have areas of decreased vascularity that cannot be appreciated by the surgeon's intraoperative exam alone. Surgeons would be able to make better decisions with respect to the vascularity if there was an imaging technique that could indicate the vascular supply of the tissues undergoing surgical reconstruction.
Laser-assisted indocyanine green fluorescent dye angiography (LA-ICG) using the SPY System (Novadaq Technologies Inc., Richmond, British Columbia, Canada) is an intraoperative vascular imaging technique that improves the ability of a surgeon to assess the vascular supply in the surgical bed. This tool, which is approved by Health Canada for reconstructive surgery, has been used extensively in breast reconstruction and gastrointestinal procedures with encouraging results. The ability to address ischemic tissues intraoperatively could potentially decrease the rate of devastating wound complications in head and neck surgery patients. The objective of this observational study is to assess the effectiveness of LA-ICG in head and neck reconstructive procedures to reduce the rate of skin necrosis and fistula.
Read the detailed description
This is a prospective, observational study in patients undergoing head and neck surgery with reconstruction. Patients will be identified preoperatively by the participating surgeons. Eligible patients will be >18 years of age with head and neck oncologic or traumatic reconstructive needs requiring surgical reconstruction of the soft tissues or bony structures of the head and neck who consent to use of ICG and the SPY System intraoperatively. Defect types to be included in the study are any hypopharyngeal defect (i.e. Total laryngectomy, total laryngectomy with partial pharyngectomy), tracheal defects, oral cavity defects at risk for devascularized mucosa, or large skin defects requiring rotation-advancement flaps for closure. Donor types to be included are pedicled locoregional muscle flaps including pectoralis muscle flaps, cervicofacial skin advancement flaps, infrascapular and suprascapular flaps, and any free flap used to reconstruct the defects mentioned previously.
- Conditions
- Head and Neck Cancer
- Being tested
- ICG and SPY system for wound complications
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG and SPY system for wound complicationsDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
ICG/SPY system for tissue viability
To determine how often ICG/SPY system can be used to determine debridement of recipient or donor tissue during head and neck reconstruction
Measured: introperatively
Secondary outcomes (1)
Amount of tissue debridement
To determine how much tissue is debrided; and how often flap design is altered due to findings of the SPY system
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start8 Dec 2016 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Why it stopped: PI has been having difficulties obtaining ICG for this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345732
- Sponsor's protocol ID
- 16-5976
- Status last verified
- Mar 2024
- First submitted
- 14 Nov 2017
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Evaluation Using Indocyanine Green and SPY Fluorescence Angiography to Prevent Wound Complications in Head and Neck Surgery Patients, an Observational Study
- ClinicalTrials.gov ID
- NCT03345732
- Acronym / sponsor ID
- 16-5976
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI has been having difficulties obtaining ICG for this project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 8 Dec 2016 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 17 Nov 2017 (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.
Wound complications, such as salivary-cutaneous fistulas and skin necrosis, result in significant patient morbidity and death. Head and neck wounds are complicated because of multiple tissue layers, critical structures and variable vascularity. When vascularity is compromised, wounds do not heal and can lead to life threatening haemorrhage or morbid infections. The field of microsurgical reconstruction has developed and expanded over the last 20 years to specifically ameliorate these issues. The challenge is that the vascularity of the microsurgical transplant or the recipient tissue bed can have areas of decreased vascularity that cannot be appreciated by the surgeon's intraoperative exam alone. Surgeons would be able to make better decisions with respect to the vascularity if there was an imaging technique that could indicate the vascular supply of the tissues undergoing surgical reconstruction.
Laser-assisted indocyanine green fluorescent dye angiography (LA-ICG) using the SPY System (Novadaq Technologies Inc., Richmond, British Columbia, Canada) is an intraoperative vascular imaging technique that improves the ability of a surgeon to assess the vascular supply in the surgical bed. This tool, which is approved by Health Canada for reconstructive surgery, has been used extensively in breast reconstruction and gastrointestinal procedures with encouraging results. The ability to address ischemic tissues intraoperatively could potentially decrease the rate of devastating wound complications in head and neck surgery patients. The objective of this observational study is to assess the effectiveness of LA-ICG in head and neck reconstructive procedures to reduce the rate of skin necrosis and fistula.
Detailed description
This is a prospective, observational study in patients undergoing head and neck surgery with reconstruction. Patients will be identified preoperatively by the participating surgeons. Eligible patients will be >18 years of age with head and neck oncologic or traumatic reconstructive needs requiring surgical reconstruction of the soft tissues or bony structures of the head and neck who consent to use of ICG and the SPY System intraoperatively. Defect types to be included in the study are any hypopharyngeal defect (i.e. Total laryngectomy, total laryngectomy with partial pharyngectomy), tracheal defects, oral cavity defects at risk for devascularized mucosa, or large skin defects requiring rotation-advancement flaps for closure. Donor types to be included are pedicled locoregional muscle flaps including pectoralis muscle flaps, cervicofacial skin advancement flaps, infrascapular and suprascapular flaps, and any free flap used to reconstruct the defects mentioned previously.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with head and neck cancer requiring surgery.
Key inclusion criteria (4 listed)
- Adult patients (>18 years old) who are undergoing reconstruction for traumatic or oncologic head and neck wounds
- Specific defects eligible are any pharyngeal, tracheal, or oral cavity defects at risk of devascularized mucosa, or large skin defects requiring skin advancement flaps. This includes laryngectomy/laryngectomy-partial pharyngectomy with primary closure.
- Patient with the above defects that will be having reconstruction with the following donor tissues: local, regional or autogenous free flaps.
- Informed consent
Key exclusion criteria (2 listed)
- Patients who are pregnant or nursing
- Patients with an allergy to iodine (contrast ICG dye contains sodium iodide)
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 and SPY system for wound complications | Diagnostic test | – |
Primary outcome
ICG/SPY system for tissue viability
Time frame: introperatively
To determine how often ICG/SPY system can be used to determine debridement of recipient or donor tissue during head and neck reconstruction
1 secondary outcome
Amount of tissue debridement
Time frame: intraoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 20 Mar 2024. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICG/SPY system for tissue viability (time frame: introperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2024.