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Investigators performing this research want to look at the use of a special imaging process during a specific throat surgery. Using this imaging may help to lower a common complication that called a pharyngocutaneous fistula (PCF). A PCF is a leak in the tube in the throat that helps with breathing and digesting food.
The imaging is called the SPY Fluorescence System. This system can identify tissue that is not receiving enough blood. The SPY Fluorescence System uses a special dye, called Indocyanine green (ICG) to better see the tissues that are not receiving enough blood. When tissue does not receive enough blood, it can lead to infection. Infection of tissue in this area of the throat can lead to PCF. The imaging takes about 1 minute and is performed in the operating room during surgery.
For this study, the investigators (who are also surgeons) will decide to remove tissue that is identified by the SPY Fluorescence System to have decreased blood flow. They will then continue with the rest of the surgery as usual. The investigators will monitor participants as they recover from surgery to identify any complications that may occur. For this research they are interested in complications during the first month after surgery since this is when PCF usually happens.
Investigators will use information that has been documented in the medical records of participants as well as during in-person physical examinations during inpatient recovery and outpatient clinical visits.
Our prior work has demonstrated the efficacy to predict pharyngocutaneous fistula using Indocyanine green (ICG) angiography. In an observational study of 41 patients who underwent salvage TL with onlay free flap reconstruction, 7 (17%) patients developed PCF. Intraoperative angiography has the ability to measure the blood flow rate (ingress) into the tissues. In patients with ingress <15 (n=25), 24% developed a PCF. In contrast, no PCF was seen in the group with ingress >15. Of note, in patients with ingress <15, there was no intervention performed as this was an observational study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients having salvage TL after failure with radiation or chemoradiation | Other | SPY intraoperative fluorescent angiography system to risk stratify patients intraoperatively into low and high risk groups for developing pharyngocutaneous fistula (PCF) postoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Removal of pharyngeal mucosa with decreased perfusion will be performed | Procedure | Surgical removal of underperfused tissue versus nonremoval of tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of PCF, within one month post total laryngectomy (TL) | Incidence of PCF, in participants identified as "high risk", utilizing the SPY Fluorescence Imaging System during total laryngectomy (TL) surgical procedure, within one month post TL. Incidence of PCF will be monitored during post operative, inpatient hospitalization as well as clinical outpatient follow up. | From enrollment through 1 month post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew E Spector, MD | Contact | 412-647-2100 | spectorme@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew E Spector, MD | University of Pittsburgh/UPMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
At the time of creation of the project, the investigators do not envision the need to share IPD with other researchers or other entities. The funding for the project is internal so there is no need to report to an external sponsor.
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Prospective, interventional
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| SPY-PHI | Device | SPY Portable Handheld Imaging (SPY-PHI) |
|
| ICG (Indocyanine Green) | Drug | ICG will be used in conjunction with the SPY-PHI system for tissue imaging. |
|
| D018307 |
| Neoplasms, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |