Indwelling Tunneled Catheter Placement for Treatment of Hepatic Hydrothorax
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of an indwelling tunneled pleural catheter (ITPC) in the management of hepatic hydrothorax that is not responsive to conventional medical therapy. Hepatic Hydrothorax (HH) is defined as an accumulation of fluid in the pleural space between the chest wall and the lung and occurs in 5-10% of patients with liver disease. Despite medical therapy with diuretics and salt restriction, many patients still experience intractable, debilitating shortness of breath, often necessitating hospital admission. Repeated thoracentesis,which is a procedure in which the hepatic hydrothorax is drained with a needle may be effective, but is often only temporary prior to the reaccumulation of fluid leading to the requirement of repeated procedures. Trans-jugular intrahepatic porto-systemic shunt (TIPS), while a valuable treatment for HH, is not always effective or able to be performed. Similarly, liver transplantation although potentially curative, is not available to many patients and may be significantly delayed. Many patients do not experience sufficient or timely relief with current conventional therapy.
详细描述
Hepatic Hydrothorax (HH) occurs in 5-10% of cirrhotic patients and remains a significant clinical challenge. Despite medical therapy with diuretics and sodium restriction, many patients still experience intractable, debilitating dyspnea and respiratory compromise. Repeated thoracentesis, while often effective, may affect prohibitively transient symptom relief and exposes the patient to repeated procedures with inherent cumulative risk. Trans-jugular intrahepatic porto-systemic shunt (TIPS), while a valuable treatment for HH, is not always effective or able to be performed. Similarly, liver transplantation although potentially curative, is not available to many patients and may be significantly delayed. Many patients do not experience sufficient or timely relief with current conventional therapy. There exists the need for additional therapies, either as a bridge to transplantation or TIPS, or for palliation when transplantation is not expected.
The insertion of an Indwelling tunneled pleural catheters (ITPC) may prove to be safe and effective in treating the dyspnea, cough, and hypoxemia associated with HH in patients refractory to conventional medical management, and serve as an effective bridge to transplantation or TIPS.
ITPCs have been shown to successfully and safely control dyspnea in patients with malignant pleural effusions; producing long-lasting plurodesis in greater than 50% of recipients. Compared to the large amount of published data regarding the use of ITPC in malignant effusions, there is a paucity of data regarding the use of ITPC in benign disease; particularly HH. A small series of four patients and a single case report have previously described the successful use of an ITPC for the management of HH. There exists the need for a prospective study to investigate the potential benefit of using ITPCs in patients with HH.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have recurrent pleural effusion due to underlying cirrhosis
- •Subjects who are potential candidates for liver transplantation
- •Subjects who are candidates for transjugular intrahepatic portosystemic shunt procedures
- •Subjects who have had at least one thoracentesis in the past three months
排除标准
- •Subjects with active bacterial or fungal infection
- •Subjectswho are not potential candidates for transplantation
- •Subjects with pleural effusions due to processes other than cirrhosis
- •Subjects who are critically ill at the time of referral, requiring intensive care unit admission
研究组 & 干预措施
ITPC
干预措施: Indwelling tunneled pleural catheter (ITPC) (Device)
结局指标
主要结局
Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax
时间窗: From date of ITPC administration until the date of first documented complication such as infection that would require catheter removal or date of pleurodesis, whichever came first, assessed up to 12 months
Feasibility of using ITPC's for the management of hepatic hydrothorax was assessed by the ability of patients to drain pleural effusions routinely via an indwelling tunneled pleural catheter for control of dyspnea related to pleural fluid accumulation. Feasibility was defined as successful catheter placement and improvement in shortness of breath following the procedure. Shortness of breath measurement was descriptive and self reported by patients on routine clinical follow up. Feasibility was also defined as patient ability to drain pleural effusions routinely at home. This was documented by patient logs documenting drainage.
次要结局
未报告次要终点
研究者
Alexander Chen
Director Interventional Pulmonolgy, Assistant Professor of Medicine, Division of Pulmonary & Critical Care
Washington University School of Medicine