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 and US, blood tests.
The injection will be in the OR under US guided, maximal dose will be 0.2mg. the follow up will be short term till 30 days post injection and long term follow up wil be till 2years.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432|
- evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- TREATMENT SAFETY BY no. of participants with adverse events [ Time Frame: 4 YEARS ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
INTRACYSTIC INJECTION OF ok432 under US guided
|Drug: OK432 (Picibanil)|
A cohort study, before the injection all the patients in the study will go through:
- US-estimate the cyst size.
- CBC, PT,PTT,INR,ASLO
- 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, year, 2 years.