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About
To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. Rapamycin is administered oral for a 6 month period.
The success rate is determined by volume reduction superior to 1/5e of the initial volume measured by MRI, impact on QOL and reduction of bleeding in case of mucosal involvement.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patient from 0 to 18 years of age, presenting with poly-cystic suprahyoid or mediastinal lymphatic.
with chronic pain or functional respiratory or swallowing impairment with a CDS score < 8
Curative treatment is not possible or associated with a high risk of morbidity ,mortality and functional and cosmetic impairment
Karnofsky Score (> 10 years of age) or Lansky score (≤10 years of age) > 50%
Biology
Negative test of pregnancy if relevant
Social security affiliation
At least 2 months after a previous procedure on the malformation
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
28 participants in 1 patient group
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Central trial contact
Pierre Fayoux, MD
Data sourced from clinicaltrials.gov
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