Tunneled Pleural Catheter in Partially Entrapped Lung

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-09-30

Brief Summary

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An open randomized, prospective, single center; parallel group trial to compare efficiency and safety of PleurX-Pleural Catheter versus standard surgical treatment in patients with malignant pleural effusion and partial entrapment of the lung.

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Detailed Description

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Patients with malignant pleural effusions undergo VATS-procedure. In the intraoperative finding of a partially entrapped lung, patients are randomized in 2 groups.

Arm 1: Insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery.

Arm 2: Insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery. Additionally, a subcutaneous tunneled catheter will be inserted and will remain in situ

Follow up period is 3 Months

Primary objective is the comparison of quality of life between the 2 arms.

Secondary objective is the reliability of the subcutaneous tunnelled catheter in practice as well as function and dysfunction of the drainage system. Clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis) are observed.

Conditions

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Malignant Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Implantation of PleurX-Pleural catheter plus talc pleurodesis

Group Type ACTIVE_COMPARATOR

VATS, Talc-Pleurodesis, tunneled pleural drainage

Intervention Type PROCEDURE

poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter

2

talc pleurodesis, no implantation of PleurX-Pleural catheter

Group Type ACTIVE_COMPARATOR

VATS, Talc-pleurodesis

Intervention Type PROCEDURE

poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter

Interventions

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VATS, Talc-Pleurodesis, tunneled pleural drainage

poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter

Intervention Type PROCEDURE

VATS, Talc-pleurodesis

poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter

Intervention Type PROCEDURE

Other Intervention Names

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Device: PleurX-Pleural Catheter no PleurX-Pleural Catheter

Eligibility Criteria

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Inclusion Criteria

* One-sided malignant pleural effusion, first occurrence, or following repeated pleuracentesis
* History of dyspnea relieved after pleuracentesis
* Patient is suitable for VATS
* Surgery is indicated by diagnostic necessity
* Ability of subject to understand character and individual consequences of clinical trial
* Written informed consent must be available before enrolment in the trial
* For women with childbearing potential, adequate contraception.
* Histological proven pleural carcinosis by immediate sectioning
* Intraoperative: partial entrapment of the lung

Exclusion Criteria

* Prior lobectomy or pneumonectomy on the affected side
* The patient is not operable for general reasons or Karnofsky performance score \< 50
* Intraoperative suspicion of a pleural empyema
* Chylothorax
* Prior attempts at pleurodesis
* Intended or prior intrapleural chemotherapy or radiotherapy
* Pregnancy and lactation
* Participation in other competing clinical trials and observation period of competing trials

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No