Malignant Pleural EffusionPhase 2NCT00637676
Tunneled Pleural Catheter in Partially Entrapped Lung
A Phase 2 study testing VATS, Talc-Pleurodesis, tunneled pleural drainage and VATS, Talc-pleurodesis in people with Malignant Pleural Effusion, run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- VATS, Talc-Pleurodesis, tunneled pleural drainage and VATS, Talc-pleurodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- For women with childbearing potential, adequate contraception.
- Histological proven pleural carcinosis by immediate sectioning
- Intraoperative: partial entrapment of the lung
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Malignant Pleural Effusion
- Being tested
- VATS, Talc-Pleurodesis, tunneled pleural drainage, VATS, Talc-pleurodesis
- Keywords
- malignant pleural effusion, subcutaneous tunneled drainage, talc pleurodesis
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS, Talc-Pleurodesis, tunneled pleural drainageProcedure or surgery
Also called Device: PleurX-Pleural Catheter
poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter
VATS, Talc-pleurodesisProcedure or surgery
Also called no PleurX-Pleural Catheter
poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Implantation of PleurX-Pleural catheter plus talc pleurodesis Receives: Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage |
| 2 | Active comparator | talc pleurodesis, no implantation of PleurX-Pleural catheter Receives: Procedure: VATS, Talc-pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
global quality scale QL2
Measured: 3 months
Secondary outcomes (1)
clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix JF Herth, Heidelberg University
- Investigators
- Hans Hoffmann, MD, PhD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637676
- Sponsor's protocol ID
- 2802
- Status last verified
- Aug 2022
- First submitted
- 11 Mar 2008
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10735665Tremblay 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.
PubMed 17567670Tremblay 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.
PubMed 16478853Harzheim 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.
PubMed 27007334
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00637676
- Acronym / sponsor ID
- 2802
- Conditions
- Malignant Pleural Effusion
- Keywords
- malignant pleural effusion, subcutaneous tunneled drainage, talc pleurodesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainageImplantation of PleurX-Pleural catheter plus talc pleurodesis |
| 2 | Active comparator | Procedure: VATS, Talc-pleurodesistalc pleurodesis, no implantation of PleurX-Pleural catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VATS, Talc-Pleurodesis, tunneled pleural drainageAlso: Device: PleurX-Pleural Catheterpoudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter | Procedure or surgery | 1 |
| VATS, Talc-pleurodesisAlso: no PleurX-Pleural Catheterpoudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter | Procedure or surgery | 2 |
Primary outcome
global quality scale QL2
Time frame: 3 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 10735665Putnam 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.
- Background: PubMed 17567670Tremblay 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.
- Background: PubMed 16478853Tremblay 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.
- Results publication: PubMed 27007334Harzheim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Hoffmann, MD, PhD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VATS, Talc-Pleurodesis, tunneled pleural drainage and VATS, Talc-pleurodesis in people with Malignant Pleural Effusion, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global quality scale QL2 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00637676, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.