A Prospective Nonrandomized Study of Laryngeal Allograft Transplantation Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Survival of the allograft at the one-year visit.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Potential subjects for this study include patients with severe laryngeal dysfunction or a previous laryngectomy. For the purposes of this study, severe laryngeal dysfunction is defined as the loss of normal laryngeal function resulting in significant dysphonia, dysphagia, or dyspnea.
- •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
排除标准
- •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
- •Unmanageable infections
- •Unable to participate in preoperative exercise training
- •Unable to be weaned to equal or less than 10 mg/day of steroids
- •Untreatable cardiac disease
- •Active neuromuscular disease
- •History of recurrent aspiration or active, unmanageable Gastro-Esophageal Reflux
- •Patients with active connective tissue diseases (exceptions to be considered in a case by case basis)
- •Patients unable to achieve > 600 feet in a 6 minute walk test (exceptions to be considered in a case by case basis)
- •Patients considered having active immunodeficiency disorders (exceptions to be considered in a case by case basis)
- •Multiple co-morbidities that would make transplantation prohibitively risky
- •Psychosocial parameters
- •Severe mental retardation, psychosis, depression or organic brain syndrome
- •Uncontrolled diabetes mellitus. Once HbA1C < 7, reevaluate for candidacy.
- •Active substance use within 6 months
- •Active smoking within 6 months
- •Active alcoholism within 6 months
- •Inability to comply with transplant-related management and medical follow-up
- •Any other circumstances that deem the candidate high risk from a psychosocial perspective
研究组 & 干预措施
Larynx Allograft Transplantation
Cadaveric laryngotracheal transplantation
干预措施: Larynx Allograft Transplantation (Procedure)
结局指标
主要结局
Survival of the allograft at the one-year visit.
时间窗: 1 year
Survival of the allograft as indicated by histological rejection grading.
次要结局
- 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)
研究者
David G. Lott, M.D.
Consultant-Department of Otolaryngology Head & Neck Surgery/Audiology
Mayo Clinic