Treatment for Pleural Effusion

Phase-Based Estimates
3
Effectiveness
3
Safety
Duke University Medical Center, Durham, NC
Pleural Effusion+1 More
Eligibility
18+
All Sexes
Eligible conditions
Pleural Effusion

Study Summary

This study is evaluating whether a new method of draining fluid from around the lung may help improve quality of life for individuals with lung cancer.

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Eligible Conditions

  • Pleural Effusion
  • Pleural Effusion, Malignant

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 2 secondary outcomes in patients with Pleural Effusion. Measurement will happen over the course of 90 Days.

90 Days
Percentage of cohort undergoing accelerated pleurodesis
Day 90
Change in Dyspnea as measured by questionnaire
Change in Qualify-of-Life as measured by questionnaire

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

1 Treatment Groups

Talc instilled via tunneled pleural catheter combined with standard daily drainage

This trial requires 152 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Talc instilled via tunneled pleural catheter combined with standard daily drainage
Drug
This arm consists of eligible participants who are randomized to the Talc arm and would receive Talc therapy instilled into the pleural catheter.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 30 days, 90 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 30 days, 90 days for reporting.

Closest Location

Duke University Medical Center - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The effusion is an accumulation of fluid that has leaked from blood vessels in the area of a tumor show original
The subject has a history of pleural effusions, one of which was ipsilateral (on the same side as the problem) and caused dyspnea (shortness of breath) show original
An IPC can be safely inserted into the pleural space of the subject because there is enough pleural fluid. show original
The subject has a negative pregnancy test if it is appropriate. show original
I consent to participate in this study. show original
Any person aged 18 or over, male or female. show original
There is histocytological confirmation of pleural malignancy
Subject agrees to maintain contact with study personnel, attend all required study visits, and answer any study-related telephone calls. show original
The subject is able to drain the pleural effusion at home. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get pleural effusion a year in the United States?

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Effusion is a leading cause of hospital admissions of older patients in the US and we speculate that the prevalence may be decreasing over time. Effusion was reported by almost all patients. In patients with parapneumonia, the decision to seek treatment often requires more reflection on risks and benefits than the treatment of pleural effusion.

Unverified Answer

What causes pleural effusion?

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Effusion may be caused by the following factors: (1) the presence of pleural tissue in the chest cavity (mostly fluid), (2) the presence of a tumour in the pleural space, (3) heart failure in the pleural space, (4) infection of the pleural space, and (5) the leakage of fluid through the diaphragm. Pneumothorax is caused by the presence of air or bone within the pleural space. Bronchopleural fistula is a special type of pleural fistula resulting from a traumatic thoracopneumonia. If the lung is completely atelectatic then a pleural effusion is not possible.

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Can pleural effusion be cured?

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Pleural effusion can be cured by pleurodesis. We recommend that a pleurodesis be used to treat pleural effusion unless no improvement can be obtained after the injection of an appropriate number of PEF.

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What is pleural effusion?

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The diagnosis of pleural effusion is not always straightforward. Its classification is a challenging issue. We propose a novel classification of pleural effusions based on the presence of underlying disease, pleural location, underlying cause, pathogenesis and clinical management.

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What are common treatments for pleural effusion?

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There is no treatment that is effective and safe in reversing pleural effusion in all people. Treatment is most effective if a precise diagnosis is made and an appropriate management plan is put into place.

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What are the signs of pleural effusion?

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pleural effusion is a rare finding on chest radiograph in hospitalized patients and its differential diagnosis (i.e., neoplastic disease) is often delayed by up to 6 weeks from symptom onset in most of these patients. This delay can result in misinterpretation of the radiographic appearance of a lesion as benign when it is actually malignant. The absence of pleural effusion on a chest radiograph may be reassuring for an alternative diagnosis.

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Is treatment typically used in combination with any other treatments?

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All patients were appropriately managed, but there was a subset of patients who were not enrolled in a clinical trial and who were being prescribed treatment that was not commonly used as reported in literature.

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What are the chances of developing pleural effusion?

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It is important for clinicians to be aware of the patient risk factors for pleural effusion. The high prevalence of pleural effusion among patients attending the medical service in the emergency department, although most of the effusions are small and do not require hospital admission and do not require hospital admission and do not require medical follow-up, supports the recommendation of the UK guidelines. Therefore, the decision to adopt such a strategy is justified in terms of medical resource management. The UK guidelines therefore seem sound in regard to patients with effusions detected incidentally on chest Radiological investigations and in those with no symptoms.

Unverified Answer

What is the survival rate for pleural effusion?

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The risk of death after transudation is relatively low except in patients with Sjögren's syndrome and renal disease. The prognosis is best in patients with pleural thickness equal to or exceeding 3 cm. Although the exact cause of the effusion is unknown, many factors are involved. Treatment is largely directed towards controlling the underlying condition (if there is any), and addressing any fluid overload. Surgery may be required if the situation worsens because a pleural fluid buildup causes significant breathing obstruction.

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Who should consider clinical trials for pleural effusion?

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Clinical trials are underutilized for pleural effusions regardless of disease nature and stage. If patients are medically stabilized and willing to take part in clinical trials, they need access to care by doctors with experience in the management of pleural effusions.

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How serious can pleural effusion be?

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Pleural effusion is associated with high mortality. The probability of developing pneumonia during long stay in patients with pleural effusion is 40%, i.e. 40% of cases. The cause of the very high mortality may be bacterial infectious endemism in patients with long stay in intensive care units. The need of further research about causative factors related to bacterial endemism in patients with pleural effusion is very important. The study of the clinical aspects which is related to the presence and severity of pleural effusion shall be further investigated.

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What is treatment?

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Pleural effusions in ICU patients are associated with an increased risk of worsening respiratory failure and mortality: an inverse relationship exists between pre-effusion lung function and time to ICU discharge, and a positive relationship exists between time to ICU discharge and worsening respiratory failure. The duration of fluid drainage should therefore be minimized. The use of prophylactic antibiotic and pleural fluid drainage is advocated.

Unverified Answer
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