Tunneled Pleural Catheter in Partially Entrapped Lung

Heidelberg University50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Malignant Pleural Effusion

Interventions

VATS, Talc-Pleurodesis, tunneled pleural drainagePROCEDURE

poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter

VATS, Talc-pleurodesisPROCEDURE

poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Thoraxklinik, University of Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

global quality scale QL2

Time frame: 3 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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