Treatment of Rhino-Sinusal Mucormycosis Through Transnasal Endoscopic Surgery Extended to the Skull Base.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Local control rate and survival rate
研究概览
简要总结
Radical endoscopic transnasal surgery associated with medical treatment with liposomal amphotericine B may increase the local control of Rhino-Sinusal Mucormycosis and the survival rate. The objective of this study is to evaluate the local control rate and survival rate at 3 months after radical endoscopic transnasal surgery extended towards the skull base in association with antifungal therapy and early surgical reevaluation of the extent of the disease.
详细描述
Introduction : Treatment of Rhino-Sinusal Mucormycosis remains a challenge because of the severity of the disease with high mortality rates. Mainly involving diabetic and immunodeficient patients, first clinical presentation is a common infection of the sinuses which can extend towards deep spaces of the face, orbits, the skull base and the brain. The mortality rates range from 20 to 50%, up to 80% in case of cerebral extension. through Transnasal Endoscopic Surgery extended to the Skull Base.
Hypothesis : We hypothesize that infected tissues are devascularized and because of that antifungal therapies can hardly reach areas of infected tissues. Radical endoscopic transnasal surgery associated with medical treatment with liposomal amphotericine B may increase the local control of the disease and the survival rate. Clinical evaluation of the extent of the disease within the first 7 days following initial surgery may represent a prognosis factor.
Methods :
First national mutlicentric and multidisciplinary cohort on Rhino-Sinusal Mucormycosis Radiological staging for evaluation of the extent of the disease using CT scan, MRI and PET Scan at initial stage before surgery Radical surgery and/or endoscopic transnasal surgery extended towards the skull base associated with liposomal amphotericine B medical treatment.
At day 7 new radiological evaluation and second surgical look to adapt surgical resection of infected tissues, perform biopsies to search for mycormycosis, biofilms and dosage of the concentration of liposomal amphotericin B inside tissues. New radiological and surgical looks in case of absence of local control obtained on the second look and further.
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
- •Man or woman, over 18 years old, presenting a mucormycosis on a sinus biopsy showing large filaments with non or little septae compatible with a mucoral or with a positive culture for a mucoral on a sinus sample associated to clinical head & neack anomalies (endoscopic) & scans compatible with a mucormycosis previous to the inclusion and this whatever the patient incumbent pathology.
- •Patient treated by liposomal amphotericin B or just before being treated
- •Signature of informed consent :
- •by the patient if he is able to express their will
- •by the family or close, if the patient is unable to consent
- •Inclusion in emergency clause is possible ( CPP agreement ) if the patient is incapacitated , no close is present and that the surgery is urgent
- •Person affiliated to a Health Security System (beneficiary)
排除标准
- •Pregnancy, breastfeeding
- •Disseminated Mucormycosis (involvment of one site distant from the head and neck)
- •Known hypersensitivity to a polyene
- •Absence of documentation of mucormycosis (histological, mycological)
- •Contraindication to the completion of the surgery as provided in this protocol
- •Patient is the subject of a guardianship or tutelage measure
结局指标
主要结局
Local control rate and survival rate
时间窗: 3 months
To evaluate the local control rate and survival rate at 3 months after radical endoscopic transnasal surgery extended towards the skull base in association with antifungal therapy and early surgical reevaluation of the extent of the disease.
次要结局
- Study of the response rate(1 and 3 months)
- Dosage of the amphotericin B concentration inside tissues(Day 7)
- Search for biofilms using confocal microscopy(Day 0 and Day 7)
- Survival rates(6 and 12 months)
- Study of the local control(3 months)
- Study of the association between local control and survival rate and response rate(3 months)
- Evaluation of the interest of CT PET scan(3 months)
- Radiological staging(3 months)
- Bank of mucormycosis tissues(Day 0, Day 7, Day 14, D21 and Day 28)
- Staging of sequellae(3 months, 6 months and 1 year)