Assessment of Treatment With Laparoscopic Fenestration or Aspiration Sclerotherapy for Large Symptomatic Hepatic Cysts (ATLAS): a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- PLD-Q 4 weeks
研究概览
简要总结
Patients with large hepatic cysts (> 5cm) may develop symptoms. These can be captured with the polycystic liver disease questionnaire (PLD-Q). Treatment of large hepatic cysts consists of aspiration sclerotherapy or laparoscopic fenestration.
The safety and efficacy of both procedures has been explored in two recent systematic reviews yet no evident conclusion regarding superiority of either procedure could be drawn.
The main objective of the ATLAS trial is to compare laparoscopic fenestration and aspiration sclerotherapy in patients with large symptomatic hepatic cysts on patient-reported outcomes.
详细描述
Rationale: Patients with large hepatic cysts(>5cm) may develop symptoms due to distention of Glisson's capsule and/or compression on other abdominal organs. Frequently reported symptoms include abdominal pain, early satiety, nausea, and dyspnea. These symptoms can be captured in the disease-specific Polycystic Liver Disease Questionnaire (PLD-Q), a validated instrument. The treatment of symptomatic liver cysts is aimed to improve symptoms and quality of life by reducing cyst volume. There are two procedures available to treat symptomatic liver cysts: percutaneous aspiration sclerotherapy and laparoscopic fenestration.
In aspiration sclerotherapy, fluid is evacuated from the liver cyst and subsequently the cyst lining is exposed to a sclerosing agent for a limited period of time. Sclerotherapy causes temporary recurrence of cyst fluid after drainage, but subsequently results in a steady decrease of cyst volume in the majority of patients.
In laparoscopic fenestration the liver is exposed through laparoscopic surgery. In this procedure the cyst is punctured and drained followed by resection of extra-hepatic cyst wall.
The safety and efficacy of aspiration sclerotherapy and laparoscopic fenestration have been explored in two recent systematic reviews. No evident conclusion could be drawn because of the retrospective study design in the vast majority of the studies and the heterogeneity among these. A randomized controlled trial is warranted to identify the possible differences in safety and efficacy in aspiration sclerotherapy and laparoscopic fenestration.
Hypothesis: The investigators expect patients treated with laparoscopic fenestration to have better clinical outcome; i.e. a lower PLD-Q score, compared to aspiration sclerotherapy, when measured 4 weeks after the procedure. The investigators expect this difference to become smaller over time (after 6 and 12 months), with loss of statistical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Hepatic cyst characteristics:
- •Large (>5 cm),
- •Symptomatic (PLD-Q score ≥20),
- •Non-parasitic on imaging (US/CT/MRI)
- •Non-neoplastic on imaging (US/CT/MRI)
- •Providing informed consent
排除标准
- •Clinical indication 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 75 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
- •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).
结局指标
主要结局
PLD-Q 4 weeks
时间窗: 4 weeks after the procedure
Comparison of PLD-Q scores 4 weeks after the procedure, adjusted for baseline PLD-Q score.
次要结局
- PLD-Q score 1, 6 and 12 months after intervention(up to 12 months)
- Cyst volume with US(up to 12 months)
- SF-36 MCS(up to 12 months)
- PLD-Q invididual symptoms(up to 12 months)
- SF 36 PCS(up to 12 months)
- EQ-5D-5L(up to 12 months)
- Liver and cyst volume(up to 12 months)
- Liver and cyst volume at recurrence(up to 12 months)
- Adverse events(up to 12 months)
- Technical success(periprocedural)
- Hospital stay(periprocedural)
- Re-intervention rates(up to 12 months)
- Cost-effectiveness iPCQ(up to 12 months)
- Cost-effectiveness iMCQ(up to 12 months)