Pleural DiseasesPhase 3NCT01366261
Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
A Phase 3 study testing semirigid thoracoscopy and rigid thoracoscopy in people with Pleural Diseases, run by Aleš Rozman at 1 site in Slovenia.
Trial summary
The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Diseases
- What is being tested?
- semirigid thoracoscopy and rigid thoracoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSlovenia
- Study dates
- Jan 2008to Nov 2011
- Phase
- Phase 3
- 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
- 18 or more years old
- unilateral pleural effusion of unknown origin
- pleural irregularities suspicious for pleural malignancy
- referral for thoracoscopy after less invasive means of diagnosis had failed
Who cannot join
- uncontrolled bleeding tendency
- unstable cardiovascular status
- severe heart failure
- ECOG performance status 4
- persistent hypoxemia after evacuation of pleural fluid
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. The second aim was to compare safety and tolerability of both types of procedure, performed in local anesthesia with addition of intravenous sedation and analgesia.
- Conditions
- Pleural Diseases
- Being tested
- semirigid thoracoscopy, rigid thoracoscopy
- Keywords
- Flex-rigid pleuroscopy, pleural biopsy, pleural effusion, safety, thoracoscopy
- Medical subject headings
- Pleural Diseases, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semirigid thoracoscopyDevice
Also called autoclavable Olympus LTF-160 (Olympus Tokyo, Japan)
thoracoscopy with semirigid instrument
rigid thoracoscopyDevice
Also called autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope
thoracoscopy with rigid instrument
| Study group | Role | What they receive |
|---|---|---|
| semirigid thoracoscopy | Experimental | Semirigid instrument which we compare was autoclavable Olympus LTF-160 (Olympus Tokyo, Japan). Handle and its controls were similar to flexible fiberoptic bronchoscope, with the insertion portion composed of 22 cm long rigid part and distal 5 cm flexible tip with angulation range 1600 up / 1300 down. The external diameter of insertion portion was 7 mm with 2,8 mm inner channel diameter. The instrument was compatible with Olympus EVIS Exera 160 and 145 and EVIS 100 and 140 video processors and light sources, otherwise employed in video-bronchoscopy. Forceps, which we used was flexible FB-55CD-1 Olympus forceps with 5 mm long cusps and diameter, which fitted the diameter of inner channel of semirigid thoracoscope. Receives: Device: semirigid thoracoscopy |
| rigid thoracoscopy | Active comparator | The rigid instrument was autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope. The length of the instrument was 29 cm with 00 direction of view and 700 field of view. The external diameter of the instrument was 10 mm with 5,2 mm inner channel diameter. The instrument was compatible with Olympus Visera OTV-S7V and EVIS Exera II CV-180 video processors. Cusps of rigid forceps had outer diameter 5 mm and length 10 mm. Receives: Device: rigid thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic adequacy of semirigid thoracoscopy
- comparison of diagnostic adequacy of both instruments (number of definitive diagnosis in each group)
- size of the biopsy specimens in mm2
- interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible)
Measured: 12 months
Secondary outcomes (1)
safety
Major adverse events:
- bleeding
- infection
- reexpansion pulmonary edema
Minor adverse events:
- transient self-limited fever
- pain
- prolongued air leak
- subcutaneous emphysema 30-day mortality
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startJan 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural DiseasesStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aleš Rozman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aleš Rozman, The University Clinic of Pulmonary and Allergic Diseases Golnik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366261
- Sponsor's protocol ID
- endo-0001
- Status last verified
- Nov 2011
- First submitted
- 31 May 2011
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rozman A, Camlek L, Marc-Malovrh M, Triller N, Kern I. Rigid versus semi-rigid thoracoscopy for the diagnosis of pleural disease: a randomized pilot study. Respirology. 2013 May;18(4):704-10. doi: 10.1111/resp.12066.
PubMed 23418922
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
- ClinicalTrials.gov ID
- NCT01366261
- Acronym / sponsor ID
- endo-0001
- Conditions
- Pleural Diseases
- Keywords
- Flex-rigid pleuroscopy, pleural biopsy, pleural effusion, safety, thoracoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Aleš RozmanUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 6 Jun 2011 (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.
The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. The second aim was to compare safety and tolerability of both types of procedure, performed in local anesthesia with addition of intravenous sedation and analgesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| semirigid thoracoscopy | Experimental | Device: semirigid thoracoscopySemirigid instrument which we compare was autoclavable Olympus LTF-160 (Olympus Tokyo, Japan). Handle and its controls were similar to flexible fiberoptic bronchoscope, with the insertion portion composed of 22 cm long rigid part and distal 5 cm flexible tip with angulation range 1600 up / 1300 down. The external diameter of insertion portion was 7 mm with 2,8 mm inner channel diameter. The instrument was compatible with Olympus EVIS Exera 160 and 145 and EVIS 100 and 140 video processors and light sources, otherwise employed in video-bronchoscopy. Forceps, which we used was flexible FB-55CD-1 Olympus forceps with 5 mm long cusps and diameter, which fitted the diameter of inner channel of semirigid thoracoscope. |
| rigid thoracoscopy | Active comparator | Device: rigid thoracoscopyThe rigid instrument was autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope. The length of the instrument was 29 cm with 00 direction of view and 700 field of view. The external diameter of the instrument was 10 mm with 5,2 mm inner channel diameter. The instrument was compatible with Olympus Visera OTV-S7V and EVIS Exera II CV-180 video processors. Cusps of rigid forceps had outer diameter 5 mm and length 10 mm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 or more years old
- unilateral pleural effusion of unknown origin
- pleural irregularities suspicious for pleural malignancy
- referral for thoracoscopy after less invasive means of diagnosis had failed
Key exclusion criteria (5 listed)
- uncontrolled bleeding tendency
- unstable cardiovascular status
- severe heart failure
- ECOG performance status 4
- persistent hypoxemia after evacuation of pleural fluid
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 |
|---|---|---|
| semirigid thoracoscopyAlso: autoclavable Olympus LTF-160 (Olympus Tokyo, Japan)thoracoscopy with semirigid instrument | Device | semirigid thoracoscopy |
| rigid thoracoscopyAlso: autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscopethoracoscopy with rigid instrument | Device | rigid thoracoscopy |
Primary outcome
diagnostic adequacy of semirigid thoracoscopy
Time frame: 12 months
* comparison of diagnostic adequacy of both instruments (number of definitive diagnosis in each group) * size of the biopsy specimens in mm2 * interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible)
1 secondary outcome
safety
Time frame: 1 month
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 11 Nov 2011.
- Derived from this study: PubMed 23418922Rozman A, Camlek L, Marc-Malovrh M, Triller N, Kern I. Rigid versus semi-rigid thoracoscopy for the diagnosis of pleural disease: a randomized pilot study. Respirology. 2013 May;18(4):704-10. doi: 10.1111/resp.12066.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing semirigid thoracoscopy and rigid thoracoscopy in people with Pleural Diseases, run by Aleš Rozman at 1 site in Slovenia.
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 4 inclusion and 5 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 11 Nov 2011. 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 Slovenia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
diagnostic adequacy of semirigid thoracoscopy (time frame: 12 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 NCT01366261, which also lists 1 linked publication.
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 11 Nov 2011.