Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432

Study Overview
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Brief Summary
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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.

Detailed Description
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A cohort study, before the injection all the patients in the study will go through: CT/MRI US to 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, 1 year, 2 years

Official Title
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Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432

Conditions
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CYSTIC MALFORMATION

Intervention / Treatment
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* Drug: Intracystic injection of OK432 under US guiding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC. ONLY IN THE HEAD AND NECK AREA TIME FROM OPERATION AT LEAST 6 MONTHS Exclusion Criteria: penicillin allergy pregnancy familial history of RF Post streptococcal glomerulonephritis Background illness-heart, kidney, lungs fever > 38.5c in the op day URT Infection Family history of PANDAS

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OK432<br>Intracystic injection of OK432 under US guiding | Drug: Intracystic injection of OK432 under US guiding<br>* Intracystic injection of OK432 under US guiding<br>* Other names: OK432 (Picibanil);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TREATMENT SAFETY BY no. of participants with adverse events |  | 4 YEARS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OK432, CYSTIC MALFORMATION