Clinical Trial: Endoscopic Surgical Treatment of Rhino-Sinusal Mucormycosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Treatment of Rhino-Sinusal Mucormycosis Through Transnasal Endoscopic Surgery Extended to the Skull Base.
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 Summary:
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 respons
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: Local control rate and survival rate [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome:
- Survival rates [ Time Frame: 3, 6 and 12 months ]Survival rates at 3, 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 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
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: July 25, 2014
Date Started: January 2015
Date Completion: January 2019
Last Updated: August 12, 2016
Last Verified: August 2016