Rapid Pleurodesis Through an Indwelling Pleural Catheter (RAPID)

University of Pennsylvania

Status: Terminated

Conditions: Pleural Effusion, Malignant; Pleural Diseases; Pleurodesis

Treatments: Other: Placebo; Drug: Rapid pleurodesis protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03325192

827688

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 2 patient groups, including a placebo group

Standard of care

Placebo Comparator group

Description:

Subjects in this arm will receive placebo only (100mL of normal saline) into the pleural space delivered via the newly placed tunneled intrapleural catheter

Treatment:

Other: Placebo

Rapid pleurodesis protocol

Experimental group

Description:

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

Treatment:

Drug: Rapid pleurodesis protocol