Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Официальное название

The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial

Обзор

Malignant pleural effusion remains a debilitating complication of end stage cancer, which can be greatly improved by the introduction of the indwelling tunneled pleural catheter (IPC). However, there is no standard of care regarding drainage and limited data on the utility of different drainage techniques. In addition, many patients develop discomfort and chest pain during drainage. The investigators propose to evaluate gravity drainage and suction drainage on quality of life measures and outcomes.

Подробное описание

Indwelling tunneled pleural catheters (IPCs) are used to alleviate pleural effusion as a first-line therapeutic (albeit palliative) intervention. Limited data currently exists on drainage techniques and the impact the techniques may have on quality of life. Current recommendations for IPC drainage range from daily drainage to once a week drainage, as well as only when needed for dyspnea. It has been theorized that active drainage of effusions may have an impact on the development of chest discomfort/pain, whereas passive regimens may allow for more gradual intrathoracic pleural changes and potentially offer a difference in drainage discomfort.

The objective of this investigation is to compare different drainage strategies of indwelling pleural catheters (IPCs) regarding patient quality of life and outcomes. Patients will undergo placement of a pleural catheter as per standard institutional protocol. Patients will be randomized on a 1:1 basis into the suction drainage (active) arm or the gravity drainage (passive) arm. Patients will receive follow-up at two weeks, four weeks, twelve weeks and then as needed post IPC placement per standard clinical protocol. All patients will be asked to fill out quality of life questionnaires and update drainage diary information with patient's providers.

Patients will undergo standard care treatment throughout the disease course and no different interventions regarding the pleural disease will be performed as a result of enrollment within this study. Study interventions/procedures will consist of questionnaires and patient self-reported documentation regarding patient's care and outcomes.

Вмешательства

• Процедура Vacuum-Based IPC
  An indwelling pleural catheter is placed inside the chest cavity to drain fluid from around the lungs. One end remains inside the body while the other drains via suction.
• Процедура Gravity-Based IPC
  An indwelling pleural catheter is placed inside the chest cavity to drain fluid from around the lungs. One end remains inside the body while the other drains via gravity.

Первичные конечные точки

• Change in chest pain as assessed by Visual Analog Scale (VAS) [Срок оценки: Daily, up to 2 weeks]

Вторичные конечные точки (3)

• Change in mean difference in chest pain as assessed by VAS [Срок оценки: pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis]
• Change in SF 36-Item Health Survey score [Срок оценки: pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis]
• Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea survey score [Срок оценки: pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis]

Критерии участия

Критерии включения

• Clinical indications for placement of IPC for malignant pleural effusion

a. Pleural effusion with symptomatic improvement in dyspnea after drainage of ipsilateral effusion

• Clinically confident symptomatic malignant pleural effusion

• Histocytological proof of pleural malignancy
• Recurrent large pleural effusion in context of histologically proven cancer outside the pleural space
• Plans for placement of IPC within ten days of enrollment
• Age > 17 years
• Sufficient fluid on ultrasound to allow for safe insertion of IPC

Критерии исключения

• Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain
• Pregnant or lactating mothers
• Previous ipsilateral chemical pleurodesis
• Current contralateral indwelling pleural catheter
• Known rib or thoracic skeletal metastasis causing pain
• Concern for active pleural infection
• Respiratory failure
• Irreversible bleeding diathesis
• Inability to provide care for indwelling tunneled pleural catheter
• Significantly loculated pleural space precluding drainage of pleural space, for which IPC alone will likely not offer symptomatic benefit
• Estimated life expectancy of < 30 days (however, active enrollment in hospice program is not an exclusion criteria)
• Inability to read/understand/write in the English language
• Inability to follow-up for appointments/protocol
• Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the investigator would mean participation in the study would be contraindicated.
• Enrollment in alternative pleural catheter trial that would preclude enrollment within this trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Northwest Community Healthcare — Arlington Heights
• Johns Hopkins Hospital — Baltimore
• Medical University of South Carolina — Charleston
• Vanderbilt University Medical Center — Nashville
• Swedish Medical Center — Seattle

Великобритания · 1 центр

• University of Oxford — Oxford

Идентификаторы

NCT: NCT03831386 · IRB00158671

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗