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临床试验/NCT02119169
NCT02119169Unknown不适用

Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax

Sherief Abd-Elsalam1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Change in chest radiography

研究概览

简要总结

The effectiveness of pigtail catheter as a less invasive option for pleural drainage in patients with resistant hepatic hydrothorax.

详细描述

Hepatic hydrothorax (HH) is defined as a transudative pleural effusion in patients with liver cirrhosis in the absence of cardiopulmonary disease. The estimated prevalence among patients with liver cirrhosis is approximately 5-6% (Baikati et al., 2014).

HH is an infrequent but a well-known complication of portal hypertension. Trans-diaphragmatic passage of ascitic fluid from peritoneal to the pleural cavity through numerous diaphragmatic defects has been shown to be the predominant mechanism in the formation of HH (Kumar&Kumar, 2014).

Patients with hepatic hydrothoraces often have few options (Goto et al., 2011). Diuretic-resistant HH could be managed with liver transplantation, transjugular intrahepatic portosystemic shunt (TIPS) or indwelling pleural catheters. However, tube thoracotomy and pleurodesis failed in most patients (Singh et al., 2013).

Case reports and small case series have reported a high rate of complications associated with chest tube placement for hepatic hydrothorax. The most common reported complications were acute kidney injury, pneumothorax, and empyema. Death has been recorded in some cases. Chest tube insertion for hepatic hydrothorax carries significant morbidity and mortality, with questionable benefit (Orman&Lok, 2009).

Pigtail catheter insertion is an effective and safe method of draining pleural fluid. Its use is safe and recommended for all cases of pleural effusion requiring chest drain except for empyema and other loculated effusions that yielded low success rate (Bediwy and Amer, 2012).

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with cirrhotic liver and recurrent pleural effusion.
  • Pleural fluid should be transudate according to Light's criteria:
  • Pleural fluid-to-serum protein ratio less than 0.5
  • Pleural fluid lactic dehydrogenase (LDH) less than 200 IU
  • Pleural fluid-to-serum LDH ratio and pleural fluid-to-high normal serum LDH ratio less than 0.6

排除标准

  • Diagnosis of hepatocellular carcinoma or other neoplasm able to shorten life expectancy.
  • Congestive heart failure.
  • Recent (i.e. within the previous 2 weeks) episode of digestive hemorrhage.
  • Exudative pleural effusion.
  • Ascitic fluid or pleural fluid infection
  • Platelet count below 50,000
  • Prothrombin activity below 50%

研究组 & 干预措施

pigtail catheter

Experimental

Pigtail catheter for pleural drainage of recurrent hepatic hydrothorax

干预措施: Pigtail catheter (Device)

结局指标

主要结局

Change in chest radiography

时间窗: baseline, daily after treatment within admission

次要结局

  • Chest X-ray and any complications recorded(weekly in first month and monthly for 3 months)

研究者

发起方
Sherief Abd-Elsalam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sherief Abd-Elsalam

doctor

Tanta University

研究点 (1)

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