Endoscopic Surgical Treatment of Rhino-Sinusal Mucormycosis
- Conditions
- Rhinocerebral Mucormycosis
- Interventions
- Procedure: Multiple transnasal endoscopic surgeries
- Registration Number
- NCT02226705
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
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.
Study of the response rate by an endoscopic \& scan follow-up (with biopsies for anatomopathological et mycological studies) at 1 month, 3 months, 6 months \& one year. PET scan initially \& at 3 months.
Number of subjects included : Phase II type trial (exclusion of a zero hypothesis of survival rate \<50% ), N= 23 patients
Total length of the study 4 years Inclusion period time : 3 years Time of participation per patient : 1 year Number of center and/or participating departments: 24 Mean number of patients included per year and per center : 0 to 3 patients
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Multiple Surgeries Multiple transnasal endoscopic surgeries Patients undergoing transnasal endoscopic surgery
- Primary Outcome Measures
Name Time Method Local control rate and survival rate 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.
- Secondary Outcome Measures
Name Time Method Study of the response rate 1 and 3 months Study of the response rate at 1 and 3 months according to Segar criteria (Segal, Clin Infect Dis) using clinical, mycological and radiological evaluation.
Dosage of the amphotericin B concentration inside tissues Day 7 Dosage of the amphotericin B concentration inside tissues (infeusingcted and at the border of infected tissues) as obtained with biopsies at day 7.
Search for biofilms using confocal microscopy Day 0 and Day 7 Search for biofilms using confocal microscopy on infected tissues biopsies
Survival rates 6 and 12 months Survival rates at 6 and 12 months
Study of the local control 3 months Study of the local control obtained at day 7+/-5 days and survival rate and response rate at 3 months.
Study of the association between local control and survival rate and response rate 3 months Study of the association between local control obtained at 1 month and survival rate and response rate at 3 months.
Evaluation of the interest of CT PET scan 3 months Evaluation of the interest of CT PET scan in studying clinical response at 3 months.
Radiological staging 3 months Radiological staging: comparison of the initial extent of the mucormycosis at day 0 by CT scan and MRI and survival rate at 3 months and local control obtained at day 7.
Bank of mucormycosis tissues Day 0, Day 7, Day 14, D21 and Day 28 Bank of mucormycosis tissues at -80°C
Staging of sequellae 3 months, 6 months and 1 year Staging of sequellae using quality of life questionnaires
Trial Locations
- Locations (1)
Hôpital Lariboisière
🇫🇷Paris, France