Indwelling Pleural Catheter for Trapped Lung

European Institute of Oncology20 enrolled

Overview

Malignant pleural effusion (MPE) is a complication of almost any site of primary cancer as well as primary tumors of the pleura. Half of MPE patients have non-expendable trapped lungs not suitable for talc pleurodesis. Indwelling pleural catheters (IPCs), however, can be used in this cohort of patients, bringing about an improvement in dyspnea and quality of life (QOL). The aim of this study is to obtain pilot data - comparing patients receiving two different types of indwelling pleural catethers normally used in clinical practice (10 patients receiving Pleurocath® and 10 patients receiving PleurX®) - for power calculation of a Randomized Controlled Trial comparing two different drainages for MPE trapped lung.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pleura; Effusion

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, with a clinical confident diagnosis of symptomatic malignant pleural effusion, enrolled for VATS exploration but not amenable of VATS talc poudrage because of trapped lung (patients with only partial expansion however receiving talc poudrage, but needing permanent pleural cathetes, are also eligible) Exclusion Criteria: * \- Age younger than 18 years * Expected survival of less than 3 months * Chylothorax * Total white blood cell count less than 1000/microL * Pregnancy or lactating mothers * Irreversible bleeding diathesis * Irreversible visual impairment * Contraindications to general anesthesia * Poor general clinical conditions ( ECOG PS \>=2) * Patients unable to provide informed consent

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain)

Thoracic pain

Time frame: Post operative day 4th

Visual Analog Scale (VAS) range 0 (no dyspnea) - 100 (maximim dyspnea)

Dyspnea