Tunneled Pleural Catheter in Partially Entrapped Lung - Tabular View

Tracking Information

First Received Date ^ICMJE

March 11, 2008

Last Updated Date

March 17, 2008

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00637676 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Tunneled Pleural Catheter in Partially Entrapped Lung

Official Title ^ICMJE

Randomized Trial of Tunneled Pleural Catheter Versus Standard Chest Tube in Management of Malignant Pleural Effusion in Patients With Partial Entrapment of the Lung

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Malignant Pleural Effusion

Intervention ^ICMJE

Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage
Procedure: VATS, Talc-pleurodesis

Study Arms / Comparison Groups

Active Comparator: Implantation of PleurX-Pleural catheter plus talc pleurodesis
Active Comparator: talc pleurodesis, no implantation of PleurX-Pleural catheter

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00637676

Responsible Party

Thomas Schneider, MD, Thoraxklinik Heidelberg

Study ID Numbers ^ICMJE

2802

Study Sponsor ^ICMJE

University of Heidelberg

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Hans Hoffmann, MD, PhD

Thoraxklinik, University of Heidelberg

Information Provided By

University of Heidelberg

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP