Hypopharynx ICG to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy

NCT ID: NCT05350540

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2028-11-30

Brief 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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICG

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

Group Type: EXPERIMENTAL

ICG dye

Intervention Type: OTHER

Patients assigned to the intervention group will undergo surgery guided by tissue perfusion as directed by the ICG imaging

Control

Patients assigned to the observation (control) group will undergo standard of care reconstruction of mucosa

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ICG dye

Patients assigned to the intervention group will undergo surgery guided by tissue perfusion as directed by the ICG imaging

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Douglas Chepeha

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Douglas Chepeha, MD

Role: CONTACT

douglas.chepeha@uhn.ca

(416) 340-3082

Alex Esemezie, BSc

Role: CONTACT

alex.esemezie@uhn.ca

(416) 340-4800 ext. 7161

Facility Contacts

Alex Esemezie, BSc

Role: primary

alex.esemezie@uhn.ca

(416) 340-4800 ext. 7161

Other Identifiers

20-5419

Identifier Type: -

Identifier Source: org_study_id