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Tunneled Pleural Catheter in Partially Entrapped Lung

Primary Purpose

Malignant Pleural Effusion

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
VATS, Talc-Pleurodesis, tunneled pleural drainage
VATS, Talc-pleurodesis
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion focused on measuring malignant pleural effusion, subcutaneous tunneled drainage, talc pleurodesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thoraxklinik, University of Heidelberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Implantation of PleurX-Pleural catheter plus talc pleurodesis

talc pleurodesis, no implantation of PleurX-Pleural catheter

Outcomes

Primary Outcome Measures

global quality scale QL2

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2008
Last Updated
August 30, 2022
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT00637676
Brief Title
Tunneled Pleural Catheter in Partially Entrapped Lung
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 Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion
Keywords
malignant pleural effusion, subcutaneous tunneled drainage, talc pleurodesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Implantation of PleurX-Pleural catheter plus talc pleurodesis
Arm Title
2
Arm Type
Active Comparator
Arm Description
talc pleurodesis, no implantation of PleurX-Pleural catheter
Intervention Type
Procedure
Intervention Name(s)
VATS, Talc-Pleurodesis, tunneled pleural drainage
Other Intervention Name(s)
Device: PleurX-Pleural Catheter
Intervention Description
poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter
Intervention Type
Procedure
Intervention Name(s)
VATS, Talc-pleurodesis
Other Intervention Name(s)
no PleurX-Pleural Catheter
Intervention Description
poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter
Primary Outcome Measure Information:
Title
global quality scale QL2
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Hoffmann, MD, PhD
Organizational Affiliation
Thoraxklinik University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoraxklinik, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
10735665
Citation
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.
Results Reference
background
PubMed Identifier
17567670
Citation
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.
Results Reference
background
PubMed Identifier
16478853
Citation
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.
Results Reference
background
PubMed Identifier
27007334
Citation
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.
Results Reference
result

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Tunneled Pleural Catheter in Partially Entrapped Lung

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