Clinical trial NCT00637676: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Pleural Effusion
Keywords: malignant pleural effusion
subcutaneous tunneled drainage
talc pleurodesis
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2008-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: global quality scale QL2
timeFrame: 3 months
Secondary outcomes:
measure: clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis)
timeFrame: 3 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik, University of Heidelberg
Study officials:
affiliation: Thoraxklinik University of Heidelberg
name: Hans Hoffmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.