Indwelling Pleural Catheter for Trapped Lung

Pleura; Effusion Clinical Trial

Official title:

Indwelling Pleural Catheter for Trapped Lung: a Pilot Study for Power Calculation of a Randomized Controlled Trial Comparing Pleurocath® Versus PleurX®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550027
• Other study ID #: R 574/17 - IEO 607
• Status: Completed
• Phase: Phase 3
• Start date: April 21, 2017
• Est. completion date: February 15, 2018

Study information

• Verified date: June 2018
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 15, 2018
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleura; Effusion
• Pleural Effusion

Intervention

Device:
• PleurX
Positioning of drainage PleurX
• Pleurocath
Positioning of drainage Pleurocath

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain)	Thoracic pain	Post operative day 4th
Primary	Visual Analog Scale (VAS) range 0 (no dyspnea) - 100 (maximim dyspnea)	Dyspnea	Post operative day 4th