An interventional study of Rapid pleurodesis protocol and Placebo in Pleural Effusion, Malignant, Pleurodesis and Pleural Diseases, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-08.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
The primary objective of the study is to evaluate whether the use of a rapid pleurodesis protocol using 10% iodopovidone immediately after tunneled pleural catheter placement improves time to IPC removal compared to patients who receive an IPC alone.
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.
169 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.
This study's enrollment of 11 is below the median of 55 across 125 interventional studies indexed under Pleural Effusion, Malignant.
Browse Pleural Effusion, Malignant studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of MPE as defined by
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this arm will receive placebo only (100mL of normal saline) into the pleural space delivered via the newly placed tunneled intrapleural catheter
Other: Placebo
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
* The pleural space will be evacuated completely through the newly placed IPC * 20mL of 10% iodopovidone and 80mL of normal saline will be instilled into the pleural space * The patient will be transferred to the recovery unit * Two hours after instillation the pleural space will be drained * After recovery from anesthesia and complete drainage of the pleurodesis mix, the subject will be discharged * Subjects will be asked to drain their effusion on a daily basis for the next 7 days and then on an every other day basis.
Also known as: iodine pleurodesis
* The pleural space will be evacuated completely through the newly placed IPC * Only placebo (normal saline) will be instilled into the pleural space * The patient will be transferred to the recovery unit * Two hours after instillation the pleural space will be drained * After recovery from anesthesia and complete drainage of the pleurodesis mix, the subject will be discharged * Subjects will be asked to drain their effusion on a daily basis for the next 7 days and then on an every other day basis.
Time to catheter removal
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.
Time frame: 90 days
Change in Global Health Related Quality of Life
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.
Time frame: 30 days, 60 days, and 90 days after catheter placement
Change in symptoms of pain and breathlessness
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 frame: 30 days, 60 days, and 90 days after catheter placement
Time to return of clinically significant pleural effusion
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
Time frame: 90 days
Rate of successful pleurodesis at 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.
Time frame: 90 days
Plan to share: No
This study is terminated, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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