A Prospective Nonrandomized Study of Laryngeal Allograft Transplantation Clinical Investigation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Larynx Stenosis
- Sponsor
- Mayo Clinic
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Survival of the allograft at the one-year visit.
- Status
- Suspended
- Last Updated
- 7 months ago
Overview
Brief Summary
The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal allograft transplantation in an effort to safely use these procedures as a viable reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.
Detailed Description
Patients with severe laryngeal or laryngotracheal incompetence without other reconstructive options will be considered for cadaveric laryngotracheal transplantation. Data will be collected from 10 patients and will include length of hospital stay, short-term complications, long-term complications, hospital readmission, return trips to the operating room (OR), rejection episodes and severity, swallowing function, ability to have tracheotomy tube decannulated, voice parameters, pulmonary function, development of anti-donor antibodies, and quality of life scores.
Investigators
David G. Lott, M.D.
Consultant-Department of Otolaryngology Head & Neck Surgery/Audiology
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Ages 18 years and older
- •Male or Female
- •One of the following:
- •Severe laryngeal dysfunction as described above
- •Laryngeal stenosis
- •5 years or longer s/p definitive management for head and neck cancer
- •Laryngeal cancer requiring total laryngectomy in a patient already on immunosuppression
- •Low-grade chondrosarcoma requiring total laryngectomy
- •Ability to obtain informed consent from the patient
Exclusion Criteria
- •Poor surgical candidacy secondary to poor physical/mental health as determined by a pre-operative medical evaluation
- •General medical status
- •Pregnancy
- •Any systemic disease which would alter life expectancy
- •Active neoplastic disease, not considered yet to be cured (Exceptional cases will be considered in case by case discussion)Less than 5 years s/p definitive management for cancer
- •Cancer within the last 5 years (Exceptional cases will be considered in case by case discussion)
- •Obesity (Body Mass Index \>29 - 30)(Exceptional cases will be considered on a case by case basis)
- •Cachexia (BMI\<18)(Exceptional cases will be considered on a case by case basis) Significant renal dysfunction (Creatinine clearance \< 50 ml/min.)
- •Significant hepatic dysfunction
- •Significant kidney damage
Outcomes
Primary Outcomes
Survival of the allograft at the one-year visit.
Time Frame: 1 year
Survival of the allograft as indicated by histological rejection grading.
Secondary Outcomes
- Ability to have tracheotomy tube decannulated(1 year)
- Swallowing without aspiration at the one-year visit.(1 year)
- Voice Evaluation(1 year)
- Pulmonary function(1 year)