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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Implantation of PleurX-Pleural catheter plus talc pleurodesis |
|
| 2 | Active Comparator | talc pleurodesis, no implantation of PleurX-Pleural catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VATS, Talc-Pleurodesis, tunneled pleural drainage | Procedure | poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| global quality scale QL2 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Hoffmann, MD, PhD | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoraxklinik, University of Heidelberg | Heidelberg | 69126 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10735665 | Background | 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. | |
| 17567670 | Background | 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. |
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| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D013906 | Thoracoscopy |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
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| VATS, Talc-pleurodesis | Procedure | poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter |
|
|
| 16478853 | Background | 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. |
| 27007334 | Result | 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. |
| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |