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


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Pleural Effusion

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

global quality scale QL2

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Hans Hoffmann, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thoraxklinik, University of Heidelberg

Authority:

Germany:Koordinierungszentrum für klinische Studien, Universitätsklinikum Heidelberg; Voßstr.2;69115 Heidelberg

Study ID:

2802

NCT ID:

NCT00637676

Start Date:

July 2008

Completion Date:

September 2011

Related Keywords:

  • Malignant Pleural Effusion
  • malignant pleural effusion
  • subcutaneous tunneled drainage
  • talc pleurodesis
  • Pleural Effusion
  • Pleural Effusion, Malignant

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