NL-OMON51055撤回3 期
Assessment of Treatment with Laparoscopic fenestration or Aspiration Sclerotherapy for large symptomatic hepatic cysts (ATLAS): a randomized clinical trial. - ATLAS-trial
niversitair Medisch Centrum0 个研究点目标入组 70 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >=18 years
- •Hepatic cyst characteristics:
- •o Large (>5 cm),
- •o Symptomatic (PLD-Q score >=20),
- •o Non-parasitic on imaging (US/CT/MRI)
- •o Non-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
- •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 10^9/l)
- •Radiologic contrast allergy
- •Pregnancy
- •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).
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