CYSTIC MALFORMATION Clinical Trial
Official title:
Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432
Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head
and neck region.
The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood
tests.
The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up
will be of short term - till 30 days post injection and long term - follow-up wil be till 2
years.
A cohort study, before the injection all the patients in the study will go through:
1. CT/MRI
2. US to estimate the cyst size
3. CBC, PT, PTT, INR, ASLO
4. ECG If the patient is qualified to the study the parent will sign on the inform
consent, than the child will be photographed AP and lateral.
The injection will be held in the OR under US guidance with 18q20 gauge needle, first all
the cyst contents will be sucked than the OK432 will be injected in.
After the injection the child will stay for one night if it was general anesthesia and 4
hours in the case of local anesthesia.
Short term follow - 3-5 days with the phone, up: till 30 days from the injection with US,
stills photo.
Long term follow-up: 6 months, 1 year, 2 years
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment