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

Primary Purpose

Surgery Site Fistula

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
ICG dye
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery Site Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ICG

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

ICG Perfusion
Perfusion of the mucosa after the administration of ICG will be recorded.
Surgical Complications
The complications the study participants experience post-surgically, if any, will be recorded.

Secondary Outcome Measures

Disease Status
The health condition and disease stage of the participants will be collected at different time points.
Laryngeal Rehabilitation
Participants' means of communication using voice prosthesis or other devices will be collected at different time points.
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.

Full Information

First Posted
April 15, 2022
Last Updated
May 30, 2022
Sponsor
University Health Network, Toronto
Collaborators
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05350540
Brief Title
Hypopharynx ICG to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
November 2028 (Anticipated)
Study Completion Date
November 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery Site Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICG
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients assigned to the observation (control) group will undergo standard of care reconstruction of mucosa
Intervention Type
Other
Intervention Name(s)
ICG dye
Intervention Description
Patients assigned to the intervention group will undergo surgery guided by tissue perfusion as directed by the ICG imaging
Primary Outcome Measure Information:
Title
ICG Perfusion
Description
Perfusion of the mucosa after the administration of ICG will be recorded.
Time Frame
Collected at time of surgery
Title
Surgical Complications
Description
The complications the study participants experience post-surgically, if any, will be recorded.
Time Frame
Collected up to 1 week after hospital discharge
Secondary Outcome Measure Information:
Title
Disease Status
Description
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
Title
Laryngeal Rehabilitation
Description
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
Title
Speech and Swallowing Questionnaire
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas Chepeha, MD
Phone
(416) 340-3082
Email
douglas.chepeha@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Esemezie, BSc
Phone
(416) 340-4800
Ext
7161
Email
alex.esemezie@uhn.ca
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Esemezie, BSc
Phone
(416) 340-4800
Ext
7161
Email
alex.esemezie@uhn.ca
First Name & Middle Initial & Last Name & Degree
Douglas Chepeha, MD

12. IPD Sharing Statement

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

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