Clinical trial NCT03325192: Rapid Pleurodesis Through an Indwelling Pleural Catheter
Official title: A Randomized, Double Blinded, Controlled Trial of a Rapid Pleurodesis Protocol After Indwelling Pleural Catheter Placement for Malignant Pleural Effusions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pleural Effusion, Malignant
Pleurodesis
Pleural Diseases
Keywords: Indwelling Pleural Catheter
Pleurodesis
Iodopovidone
Pleural Effusion, Malignant
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Controlled, Double Blinded, Parallel Design, Trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of MPE as defined by

   1. A diagnosis a pleural effusion in the setting of known malignancy. AND
   2. Confirmed malignant involvement of the pleural space by fluid cytology or pleural biopsy. OR
   3. Evidence of pleural disease on radiographic imaging. OR
   4. A recurrent effusion with no other identifiable cause after thorough workup.
2. Symptomatic from the pleural effusions (shortness of breath, cough, or chest pain)
3. Prior thoracentesis with post procedure symptomatic relief
4. Recurrence of symptoms with re-accumulation of pleural effusion
5. Lung re-expansion after thoracentesis on chest imaging within last 30 days

Exclusion Criteria:

1. Malignant pleural effusion due to a hematologic malignancy
2. ECOG \>4
3. Any history of trapped lung
4. Prior attempted pleurodesis on the affected site
5. Age \<18
6. Pregnant or lactating
7. Known allergy to iodopovidone (Betadine)
8. Unable or unwilling to provide consent
9. Uncorrectable coagulopathy (INR \> 1.5, aPTT \> 1.5 x the upper limit of normal) or thrombocytopenia (\< 50,000)
10. Anatomic contraindication to IPC (overlying skin abnormalities)
11. Unable or unwilling to care for IPC and adhere to drainage protocol
12. Need for bilateral IPC placement

Primary outcomes:
measure: Time to catheter removal
timeFrame: 90 days
Secondary outcomes:
measure: Change in Global Health Related Quality of Life
timeFrame: 30 days, 60 days, and 90 days after catheter placement
measure: Change in symptoms of pain and breathlessness
timeFrame: 30 days, 60 days, and 90 days after catheter placement
measure: Time to return of clinically significant pleural effusion
timeFrame: 90 days
measure: Rate of successful pleurodesis at 90 days
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kevin C Ma
role: PRINCIPAL_INVESTIGATOR
References:
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