Surgery Site FistulaPhase 2NCT05350540
Hypopharynx ICG to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy
A Phase 2 study testing ICG dye in people with Surgery Site Fistula, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
A laryngectomy involves removing the voice box from the throat. After the voice box has been removed from the throat, the surgeon sews the throat closed. Sometimes part of the throat does not heal and saliva runs out of the throat. This is called a fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery Site Fistula
- What is being tested?
- ICG dye
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2021to Nov 2028
- Phase
- Phase 2
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
Who may be able to join
- Signed written and voluntary informed consent.
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Age > 18 years, male or female.
- Patient must be undergoing salvage laryngectomy after radiation or chemoradiation. By definition, the patients are considered resectable by the treating head and neck surgeon.
- The expected pharyngeal defect must be conducive to imaging with the ICG.
- Vascularized tissue augmentation (flap) is part of the operative plan (supra- or infraclavicular flap excludes the patient).
- ECOG performance status 0-2.
Who cannot join
- Total Laryngopharyngectomy
- On immune suppression medications
- Current hematologic malignancy
- Pregnancy
- Allergy to Iodine
- TSH greater than 8
- BMI less than 18
- Vascularized augmentation is a supra or infraclavicular rotational flap
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Alex Esemezie, BSc, (416) 340-4800 ext. 7161, alex.esemezie@uhn.ca
Douglas Chepeha, MD
About this study
Official title: Randomized Phase II Study to Compare Intraoperative Indocyanine Green (ICG) Imaging and Guided Mucosal Debridement vs Observation (Standard of Care) to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy
A laryngectomy involves removing the voice box from the throat. After the voice box has been removed from the throat, the surgeon sews the throat closed. Sometimes part of the throat does not heal and saliva runs out of the throat. This is called a fistula. When a fistula happens, healing takes longer and patients will have to wait to eat and start speaking. The test in this research project is called ICG scan (indocyanine green) and tells the surgeon how much blood is flowing to different parts of the throat. If the test shows that there are parts of your throat that have low blood flow, which will delay healing. Only half of the patients in the study will get the ICG scan. This is so the patients who had the ICG scan can be compared to the patients that did not have the ICG scan to determine if the ICG scan really helps decrease fistulas.
Read the detailed description
Salvage laryngectomy is associated with the highest morbidity and mortality in head and neck cancer patients. Pharyngocutaneous fistula is one of the most common surgical complication in the patient population and affects up to a third of patients undergoing total laryngectomy (TL) and pharyngolaryngectomy (PL). PCF is associated to increased rates of wound infections, prolonged hospitalization and vascular embarrassment (rupture and hemorrhage from major vessels). The use of vascularized flaps to assist in the reconstruction of the pharynx after laryngectomy have reduced the severity of complications patients experience after salvage laryngectomy. There is now interest in the quality of the vascular supply of the recipient pharyngeal tissue (pharyngeal mucosa). It is possible that vascular imaging of the recipient pharyngeal mucosa would provide the surgeon with intraoperative information that could guide pharyngeal mucosal debridement to remove any remaining pharyngeal tissue that has marginal vascularity (viability).
Initially developed in the 1950's, ICG imaging was used to assess retinal perfusion. Imaging acquisition with ICG uses a near-infrared wavelength (835nm) laser detection system. ICG imaging can also be used to direct debridement of marginally viable tissue. This approach has significantly reduced wound complications in patients undergoing breast reconstruction and colorectal surgery. ICG imaging has thus been found to be a reliable predictor of mucosal viability. Perfusion imaging studies in colorectal surgery, using laser fluorescence angiography, have shown a notable reduction in surgical revisions associated to anastomotic leaks, and a reduced hospitalization time. Preliminary reports in head and neck reconstructive surgery have shown an association between poor mucosal vascularity and higher fistula rate. In addition, ICG imaging and guided mucosal debridement suggest lower fistula rates.
We will be conducting a Phase II randomized trial study to assess the utility of ICG imaging for tissue perfusion, in order to reduce pharyngocutaneous fistula rate among patients undergoing salvage laryngectomy and vascularized tissue (flap) closure
- Conditions
- Surgery Site Fistula
- Being tested
- ICG dye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG dyeOther
Patients assigned to the intervention group will undergo surgery guided by tissue perfusion as directed by the ICG imaging
| Study group | Role | What they receive |
|---|---|---|
| ICG | Experimental | This study will use intraoperative ICG imaging to assess recipient pharyngeal tissue perfusion. The ICG is the vascular contrast agent and the SPY Elite is the imaging device. 3mL of ICG will be injected using a peripheral IV access, followed by a 10mL saline flush. The pharyngeal mucosa will be imaged to quantify the tissue perfusion. Poorly perfused areas (less than 25%) will be debrided Receives: Other: ICG dye |
| Control | No intervention | Patients assigned to the observation (control) group will undergo standard of care reconstruction of mucosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICG Perfusion
Perfusion of the mucosa after the administration of ICG will be recorded.
Measured: Collected at time of surgery
Surgical Complications
The complications the study participants experience post-surgically, if any, will be recorded.
Measured: Collected up to 1 week after hospital discharge
Secondary outcomes (3)
Disease Status
The health condition and disease stage of the participants will be collected at different time points.
Measured: Collected at times week 1, 3 months, 6 months, and 12 months
Laryngeal Rehabilitation
Participants' means of communication using voice prosthesis or other devices will be collected at different time points.
Measured: Collected at times week 1, 3 months, 6 months, and 12 months
Speech and Swallowing Questionnaire
This is a disease specific, 5-item, administered questionnaire to evaluate post-treatment speech and swallowing ability measure will provide critical data on the socialization of the patient as it relates to speaking and eating.
Measured: Administered at times week 1, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start11 Nov 2021
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery Site FistulaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Douglas Chepeha, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350540
- Sponsor's protocol ID
- 20-5419
- Status last verified
- May 2022
- First submitted
- 15 Apr 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No