Endoscopic Surgical Treatment of Rhino-Sinusal Mucormycosis (MICCA)
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|ClinicalTrials.gov Identifier: NCT02226705|
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : August 27, 2014
Last Update Posted : August 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rhinocerebral Mucormycosis||Procedure: Multiple transnasal endoscopic surgeries||Phase 2|
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.
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Rhino-Sinusal Mucormycosis Through Transnasal Endoscopic Surgery Extended to the Skull Base.|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Multiple Surgeries
Patients undergoing transnasal endoscopic surgery
Procedure: Multiple transnasal endoscopic surgeries
Transnasal endoscopic surgery extended to the skull base
- Local control rate and survival rate [ Time Frame: 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.
- Survival rates [ Time Frame: 6 and 12 months ]Survival rates at 6 and 12 months
- Study of the response rate [ Time Frame: 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.
- Study of the local control [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months ]Evaluation of the interest of CT PET scan in studying clinical response at 3 months.
- Radiological staging [ Time Frame: 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.
- Dosage of the amphotericin B concentration inside tissues [ Time Frame: 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 [ Time Frame: Day 0 and Day 7 ]Search for biofilms using confocal microscopy on infected tissues biopsies
- Staging of sequellae [ Time Frame: 3 months, 6 months and 1 year ]Staging of sequellae using quality of life questionnaires
- Bank of mucormycosis tissues [ Time Frame: Day 0, Day 7, Day 14, D21 and Day 28 ]Bank of mucormycosis tissues at -80°C
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226705
|Contact: Cecile KEDZIA||+33(0) 1 44 84 17 email@example.com|
|Paris, France, 75010|
|Contact: Romain KANIA, PhD, MD 01 49 95 80 57 firstname.lastname@example.org|
|Principal Investigator: Romain KANIA, PhD, MD|
|Principal Investigator:||Romain KANIA, PhD, MD||Assistance Publique - Hôpitaux de Paris|