Tunneled Pleural Catheter in Partially Entrapped Lung - Full Text View

Sponsor:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00637676

Purpose

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.

Condition	Intervention	Phase
Malignant Pleural Effusion	Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage Procedure: VATS, Talc-pleurodesis	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study
Official Title:	Randomized Trial of Tunneled Pleural Catheter Versus Standard Chest Tube in Management of Malignant Pleural Effusion in Patients With Partial Entrapment of the Lung

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

global quality scale QL2 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Implantation of PleurX-Pleural catheter plus talc pleurodesis	Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter
2: Active Comparator talc pleurodesis, no implantation of PleurX-Pleural catheter	Procedure: VATS, Talc-pleurodesis poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637676

Contacts

Contact: Thomas Schneider, MD	0049 6221 396 8107	thomas.schneider@thoraxklinik-heidelberg.de
Contact: Hans Hoffmann, MD, PhD	0049 6221 396 8104	hans.hoffmann@urz.uni-heidelberg.de

Locations

Germany
Thoraxklinik am Universitätsklinikum Heidelberg
69115 Heidelberg, Germany

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Hans Hoffmann, MD, PhD

Thoraxklinik, University of Heidelberg

More Information

Publications:

Putnam JB Jr, Walsh GL, Swisher SG, Roth JA, Suell DM, Vaporciyan AA, Smythe WR, Merriman KW, DeFord LL. Outpatient management of malignant pleural effusion by a chronic indwelling pleural catheter. Ann Thorac Surg. 2000 Feb;69(2):369-75.

Tremblay A, Mason C, Michaud G. Use of tunnelled catheters for malignant pleural effusions in patients fit for pleurodesis. Eur Respir J. 2007 Oct;30(4):759-62. Epub 2007 Jun 13.

Tremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest. 2006 Feb;129(2):362-8.

Responsible Party:	Thoraxklinik Heidelberg ( Thomas Schneider, MD )
Study ID Numbers:	2802
Study First Received:	March 11, 2008
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00637676 History of Changes
Health Authority:	Germany:Koordinierungszentrum für klinische Studien, Universitätsklinikum Heidelberg; Voßstr.2;69115 Heidelberg

Keywords provided by University of Heidelberg:

malignant pleural effusion
subcutaneous tunneled drainage
talc pleurodesis

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Pleural Effusion
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Pleural Diseases
Pleural Effusion, Malignant
Pleural Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009