Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion

PRIMARY OBJECTIVE:

I. To evaluate dyspnea using the visual analog scale (VAS) scale at one week in patients with symptomatic septated malignant neoplasm of the pleural effusion (MPE) and a non-draining/inadequately draining indwelling pleural catheter (IPC).

SECONDARY OBJECTIVE:

I. To evaluate dyspnea using the visual analog scale (VAS) scale at 48 hours (+/-12 hours) after treatment with intrapleural alteplase, in patients with septated MPE and a nondraining/inadequately draining IPC. In addition, complications, quality adjusted survival (calculated using the SF-6D to determine utilities and then integrating utilities over time to arrive at quality-adjusted survival), change in dyspnea (using the Borg score and VAS scale) at 1 week (+/- 1 day), 2 weeks (+/- 2 days) and every 4 weeks (+/- 2 days) after the intervention until IPC removal or death.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.

ARM II: Patients receive placebo instilled into the IPC which is capped for 1-2 hours before the catheter is drained. Beginning 1 week later, patients may receive alteplase as in arm I.

Inclusion criteria

• Referral to pulmonary services for inability to drain fully via IPC
• Presence of a symptomatic septated pleural effusion
• A pleural effusion of significant moderate to large volume based on:

• Chest radiograph: effusion filling >= 1/3 of the hemithorax, or
• Computed tomography (CT)-scan: AP depth of the effusion >= 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung surrounded by effusion, or
• Ultrasound: effusion spanning at least three intercostal spaces, with a >= 3 cm in at least one intercostal space, while the patient sits upright
• Age > 18
• Borg score >= 3
• Absence of a blocked IPC as demonstrated by a flush with 20 cc of saline x1 without resistance
• Presence of septated effusion based on ultrasound (US) and chest CT

Exclusion criteria

• Inability to provide informed consent
• Study subject has any disease or condition that interferes with safe completion of the study including:

• Uncorrectable coagulopathy based on criteria followed by cardiopulmonary center for procedures.
• Active bleeding
• Known allergic reaction to thrombolytics
• Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
• No septations and/or no loculations on bedside pre-procedure ultrasound
• Patient is asymptomatic
• Blocked IPC as determined by saline flush