Tunneled Pleural Catheter in Partially Entrapped Lung

Malignant Pleural Effusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637676
• Other study ID #: 2802
• Status: Completed
• Phase: Phase 2
• Start date: July 2008
• Est. completion date: September 2011

Study information

• Verified date: August 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Procedure:
• VATS, Talc-Pleurodesis, tunneled pleural drainage
poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter
• VATS, Talc-pleurodesis
poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter

Locations

Country	Name	City	State
Germany	Thoraxklinik, University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. — View 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. Epub 2007 Jun 13. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	global quality scale QL2		3 months
Secondary	clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis)		3 months