Tunneled Pleural Catheter in Partially Entrapped Lung
Information source: University of Heidelberg
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malignant Pleural Effusion
Intervention: VATS, Talc-Pleurodesis, tunneled pleural drainage (Procedure); VATS, Talc-pleurodesis (Procedure)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: University of Heidelberg Official(s) and/or principal investigator(s):
Hans Hoffmann, MD, PhD, Principal Investigator, Affiliation: Thoraxklinik, University of Heidelberg
Overall contact:
Thomas Schneider, MD, Phone: 0049 6221 396 8107, Email: thomas.schneider@thoraxklinik-heidelberg.de
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.
Clinical Details
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
Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study
Primary outcome: global quality scale QL2
Secondary outcome: clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis)
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Thomas Schneider, MD, Phone: 0049 6221 396 8107, Email: thomas.schneider@thoraxklinik-heidelberg.de
Thoraxklinik am Universitätsklinikum Heidelberg, 69115 Heidelberg, Germany
Additional Information
Related 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.
Starting date: April 2008
Ending date: June 2009
Last updated: March 17, 2008
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