Tunneled Pleural Catheter in Partially Entrapped Lung

Heidelberg University

Status and phase: Completed; Phase 2

Conditions: Malignant Pleural Effusion

Treatments: Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage; Procedure: VATS, Talc-pleurodesis

Study type: Interventional

Funder types: Other

Identifiers

NCT00637676

2802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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50 participants in 2 patient groups

1

Active Comparator group

Description:

Implantation of PleurX-Pleural catheter plus talc pleurodesis

Treatment:

Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage

2

Active Comparator group

Description:

talc pleurodesis, no implantation of PleurX-Pleural catheter

Treatment:

Procedure: VATS, Talc-pleurodesis