Cholangitis Definition and Treatment After Kasai Hepatoportoenterostomy for Biliary Atresia: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the applicability of the definitions for suspected and confirmed cholangitis.
研究概览
简要总结
Biliary atresia is a rare liver disease affecting newborns. In those babies bile ducts are blocked, and bile cannot flow from the liver to the intestines. Biliary atresia patients require a special surgery called "Kasai operation" to restore the bile flow. A common and serious problem after surgery is an infection of the bile ducts, called cholangitis, which can damage the liver and lead an earlier need for liver transplantation.
In 2022, a group of international experts led by the Swiss Pediatric Liver Center from the HUG created new guidelines to help identify and treat cholangitis more consistently.
This study will test how well these new definitions work in real life of hospitals. Over one year, physicians will collect data on children in whom they suspect cholangitis in the first year after their Kasai. The goal is to see whether these new definitions are applicable in the clinical setting.
The study will involve around 40 patients and will use secure methods to store data. The findings will help improve how cholangitis is diagnosed and treated, making care more effective and consistent for children with biliary atresia.
详细描述
This prospective, observational study will be conducted across hospitals managing pediatric biliary atresia patients. Data on suspected cholangitis cases in the first year post Kasai hepatoportoenterostomy will be collected by mini-teams of three healthcare providers over twelve months. Data will be anonymized, and the study will adhere to international ethical standards.
Inclusion Criteria:
- Patients with biliary atresia suspected of cholangitis within one year post Kasai hepatoportoenterostomy.
- Data from specialties including pediatric surgery, pediatric hepatology, and pediatric emergency care.
Exclusion Criteria:
• Recurrent cholangitis or cholangitis after one-year post Kasai hepatoportoenterostomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a suspected diagnosis cholangitis within 1 year after Kasai hepatoportoenterostomy
排除标准
- •recurrent cholangitis, cholangitis >1 year after Kasai
结局指标
主要结局
To assess the applicability of the definitions for suspected and confirmed cholangitis.
时间窗: 12 months
次要结局
- Duration of treatment for suspected and confirmed cholangitis(1 year)
研究者
Calinescu Ana M.
PD Dr Ana M. Calinescu
University Hospital, Geneva