NL-OMON20962尚未招募不适用
Assessment of Treatment with Laparoscopic fenestration or Aspiration Sclerotherapy for large symptomatic hepatic cysts (ATLAS): a randomized clinical trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Radboudumc
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age =18 years
- •Hepatic cyst characteristics:
- •oLarge (>5 cm),
- •oSymptomatic (PLD-Q score =20),
- •oNon-parasitic on imaging (US/CT/MRI)
- •oNon-neoplastic on imaging (US/CT/MRI)
- •Providing informed consent
排除标准
- •Clinical suspicion of a complicated hepatic cyst (cyst rupture or active cyst infection)
- •Cyst is not laparoscopically accessible for surgery
- •Cyst is not percutaneously (ultrasound-guided) accessible for aspiration
- •More than 20 cysts of >1.5 cm
- •Age above 70 years
- •ECOG score >1
- •Aspiration sclerotherapy or laparoscopic fenestration of hepatic cysts was performed in the last 6 months.
- •Severe renal impairment (eGFR < 30 ml/min/1,73 m2)
- •Coagulopathy (spontaneous INR >2 or platelet count < 80 x 109/l)
- •Radiologic contrast allergy
- •Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator (e.g. inability to fill out questionnaires).
研究者
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