A Phase 2 interventional study of ICG dye in Surgery Site Fistula, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-02.
Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment
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.
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
731 studies on the registry are indexed under Fistula; 103 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 484 interventional studies indexed under Fistula.
Browse Fistula studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
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
Other: ICG dye
Patients assigned to the observation (control) group will undergo standard of care reconstruction of mucosa
Patients assigned to the intervention group will undergo surgery guided by tissue perfusion as directed by the ICG imaging
ICG Perfusion
Perfusion of the mucosa after the administration of ICG will be recorded.
Time frame: Collected at time of surgery
Surgical Complications
The complications the study participants experience post-surgically, if any, will be recorded.
Time frame: Collected up to 1 week after hospital discharge
Disease Status
The health condition and disease stage of the participants will be collected at different time points.
Time frame: 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.
Time frame: 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.
Time frame: Administered at times week 1, 3 months, 6 months, and 12 months
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University Health Network, Toronto