NCT00637676

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

2.9 years

First QC Date

March 11, 2008

Last Update Submit

August 30, 2022

Conditions

Malignant Pleural Effusion

Keywords

malignant pleural effusionsubcutaneous tunneled drainagetalc pleurodesis

Outcome Measures

Primary Outcomes (1)

  • global quality scale QL2

    3 months

Secondary Outcomes (1)

  • clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis)

    3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Implantation of PleurX-Pleural catheter plus talc pleurodesis

Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage

2

ACTIVE COMPARATOR

talc pleurodesis, no implantation of PleurX-Pleural catheter

Procedure: VATS, Talc-pleurodesis

Interventions

VATS, Talc-Pleurodesis, tunneled pleural drainagePROCEDURE

poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter

Also known as: Device: PleurX-Pleural Catheter
1
VATS, Talc-pleurodesisPROCEDURE

poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter

Also known as: no PleurX-Pleural Catheter
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thoraxklinik, University of Heidelberg

Heidelberg, 69126, Germany

Location

Related Publications (4)

  • 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. doi: 10.1016/s0003-4975(99)01482-4.

    PMID: 10735665BACKGROUND

  • 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. doi: 10.1183/09031936.00164706. Epub 2007 Jun 13.

    PMID: 17567670BACKGROUND

  • Tremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest. 2006 Feb;129(2):362-368. doi: 10.1378/chest.129.2.362.

    PMID: 16478853BACKGROUND

  • Harzheim D, Sterman D, Shah PL, Eberhardt R, Herth FJ. Bronchoscopic Transparenchymal Nodule Access: Feasibility and Safety in an Endoscopic Unit. Respiration. 2016;91(4):302-6. doi: 10.1159/000445032. Epub 2016 Mar 24.

    PMID: 27007334RESULT

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Hans Hoffmann, MD, PhD

    Thoraxklinik University of Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 18, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

September 2, 2022

Record last verified: 2022-08

Locations

DE(1)