Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC.
- •ONLY IN THE HEAD AND NECK AREA
- •TIME FROM OPERATION AT LEAST 6 MONTHS
排除标准
- •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
研究组 & 干预措施
OK432
Intracystic injection of OK432 under US guiding
干预措施: Intracystic injection of OK432 under US guiding (Drug)
结局指标
主要结局
evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence
时间窗: 4 years
次要结局
- TREATMENT SAFETY BY no. of participants with adverse events(4 YEARS)