Tunneled Pleural Catheter in Partially Entrapped Lung

August 30, 2022 updated by: Felix JF Herth, Heidelberg University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69126
        • Thoraxklinik, University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • no PleurX-Pleural Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
global quality scale QL2
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Hans Hoffmann, MD, PhD, Thoraxklinik University of Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 17, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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