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Tunneled Pleural Catheter in Partially Entrapped Lung

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felix JF Herth, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00637676
First received: March 11, 2008
Last updated: September 22, 2011
Last verified: March 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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 Heidelberg University:

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: July 2008
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Other Name: Device: PleurX-Pleural Catheter
Active Comparator: 2
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
Other Name: no PleurX-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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Thoraxklinik, University of Heidelberg
Heidelberg, Germany, 69126
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Hans Hoffmann, MD, PhD Thoraxklinik, University of Heidelberg
  More Information

Publications:
Responsible Party: Felix JF Herth, Head, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00637676     History of Changes
Other Study ID Numbers: 2802
Study First Received: March 11, 2008
Last Updated: September 22, 2011
Health Authority: Germany:Koordinierungszentrum für klinische Studien, Universitätsklinikum Heidelberg; Voßstr.2;69115 Heidelberg

Keywords provided by Heidelberg University:
malignant pleural effusion
subcutaneous tunneled drainage
talc pleurodesis

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Neoplasms
Neoplasms by Site
Pleural Diseases
Pleural Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014