Tunneled Pleural Catheter in Partially Entrapped Lung

Phase 2

Completed

• Conditions: Malignant Pleural Effusion
• Interventions: Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage; Procedure: VATS, Talc-pleurodesis

• Registration Number: NCT00637676
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-18
• Study Start: 2008-07
• Primary Completion: 2011-06
• Study Completion: 2011-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	VATS, Talc-Pleurodesis, tunneled pleural drainage	Implantation of PleurX-Pleural catheter plus talc pleurodesis
2	VATS, Talc-pleurodesis	talc pleurodesis, no implantation of PleurX-Pleural catheter

Primary Outcome Measures

Name	Time	Method
global quality scale QL2	3 months

Secondary Outcome Measures

Name	Time	Method
clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis)	3 months

Trial Locations

Locations (1)

Thoraxklinik, University of Heidelberg; 🇩🇪 Heidelberg, Germany