Rapid Pleurodesis Through an Indwelling Pleural Catheter (RAPID)
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|ClinicalTrials.gov Identifier: NCT03325192|
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : December 14, 2017
|Condition or disease||Intervention/treatment|
|Pleural Effusion, Malignant Pleurodesis Pleural Diseases||Drug: Rapid pleurodesis protocol Other: Placebo|
Patients will be screened throughout the year as part of the clinical referral process to the Interventional Pulmonology service at the Hospital of the University of Pennsylvania for the management of a malignant pleural effusion. Patients eligible for inclusion based on the clinical evaluation will be approached for enrollment. Written consent will be obtained. Patients will subsequently undergo placement of a IPC under MAC as per standard clinical practice followed by complete drainage of the pleural space. Patients randomized to the rapid pleurodesis protocol arm will received 20mL of 10% iodopovidone mixed with 80mL of normal saline instilled intrapleurally through the IPC. Patients randomized to the standard of care arm will have 100mL of normal saline (placebo) instilled intrapleurally through the IPC. The mixture will be allowed to dwell for 2 hours and then completely evacuated through the IPC and the patient will be discharged home.
After discharge, all patients will continue to drain their IPC on a daily basis for 7 days. Following this, all patients will continue to drain their IPC on an every-other-day basis until total IPC output is less than 50ml per session over 3 consecutive sessions. At which point they will be asked to undergo a clamp trial of no drainage for 7 days followed by a reattempt at drainage. Patients without return of symptoms over those 7 days and minimal drainage afterwards (<50ml) will be seen in the office for possible IPC removal. Patients with return of symptoms during those 7 days or more than minimal drainage afterwards (>50mL) will be asked to continue drainage until total IPC output is again less than 50mL per session over 3 sessions.
After a passed clamp trial, patients will be evaluated in the office with a bedside ultrasound to assess for pleural apposition in 5 of 6 designated points and the absence of pleural effusions. If all criteria are met, the IPC is removed. If there is evidence of residual effusion, continued drainage will be advised.
All patients will be evaluated in the office on day 7, day 14, day 30, day 60 and day 90 after IPC placement. On each visit they will be assessed for pleural apposition with ultrasound. At day 30, 60, and 90 all patients will receive a global health related questionnaire (EORTC QLQ30) and a symptom questionnaire. At 90 days, complications rate will be assessed for the entire study period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, Randomized, Controlled, Double Blinded, Parallel Design, Trial|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
Subject assignment will be done using randomly generated assignment tables based on stratification by tumor type (Lung, Breast, Other) and assigned 1:1 using random permuted blocks of 4.
Subjects will be blinded to their group assignment to minimize bias on follow up surveys.
Physicians evaluating the patient during the initial visit and on subsequent postprocedure followup will be blinded to subject assignment. The provider responsible for placement of the catheter and delivery of the pleurodesis agent or placebo will not be involved in post procedure followup care
All treatment physicians will follow prespecified protocols in deciding on adequate pleurodesis and timing of IPC removal.
|Official Title:||A Randomized, Double Blinded, Controlled Trial of a Rapid Pleurodesis Protocol After Indwelling Pleural Catheter Placement for Malignant Pleural Effusions|
|Actual Study Start Date :||December 12, 2017|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||July 2019|
Placebo Comparator: Standard of care
Subjects in this arm will receive placebo only (100mL of normal saline) into the pleural space delivered via the newly placed tunneled intrapleural catheter
Experimental: Rapid pleurodesis protocol
Subjects in this arm will receive the chemical pleurodesing agent of 10% iodopovidone solution delivered to the pleural space via the newly placed tunneled intrapleural catheter
Drug: Rapid pleurodesis protocol
Other Name: iodine pleurodesis
- Time to catheter removal [ Time Frame: 90 days ]Time to IPC removal will be measured in days from the day of IPC placement to the day of IPC removal after meeting removal criteria as listed above.
- Change in Global Health Related Quality of Life [ Time Frame: 30 days, 60 days, and 90 days after catheter placement ]The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQC30) will be used to assess global health-related quality of life. This is a 30-item questionnaire validated for use in patients with cancer. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
- Change in symptoms of pain and breathlessness [ Time Frame: 30 days, 60 days, and 90 days after catheter placement ]We will use a 5 point Likert scale (5PLS) that has been created for the trial. Patients will be asked to indicate their degree of shortness of breath or chest pain during sitting, walking and lying down/sleeping on that specific day. Thus, a total of 6 scales will be utilized. Point 1 will be described as "no shortness of breath" or "no chest pain." Point 2 will be described as "mild shortness of breath" or "mild chest pain." Point 3 will be described as "moderate shortness of breath" or "moderate chest pain." Point 4 will be described as "severe shortness of breath" or "severe chest pain." Point 5 will be described as "Worst shortness of breath possible" or "Worst chest pain possible."
- Time to return of clinically significant pleural effusion [ Time Frame: 90 days ]This will be measured in days from the day of IPC removal to the day of return of a clinically significant pleural effusion in the same hemithorax that originally required IPC placement. A clinically significant reaccumulation of pleural fluid will be defined as an effusion with a maximum fluid depth greater than 25% of the AP window on chest CT or 1cm thoracic ultrasound along the lateral 1/3 of the thorax that is associated with shortness of breath or chest pain
- Rate of successful pleurodesis at 90 days [ Time Frame: 90 days ]Successful pleurodesis will be defined as removal of the IPC with no clinically significant reaccumulation of pleural fluid as evaluated by chest CT or thoracic ultrasound. A clinically significant reaccumulation of pleural fluid will be defined as an effusion with a maximum fluid depth greater than 25% of the AP window on chest CT or 1cm thoracic ultrasound along the lateral 1/3 of the thorax that is associated with shortness of breath or chest pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325192
|Contact: Kevin C Ma, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: David M DiBardino, MD 215-615-0359 email@example.com|
|Principal Investigator:||David DiBardino||University of Pennsylvania|