Pleurisy With EffusionRISENCT01726556
A Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
A study testing Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany) and Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan) in people with Pleurisy With Effusion, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument designed for the same purpose which is claimed to be more user-friendly. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pleurisy With Effusion
- What is being tested?
- Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany) and Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2011to Dec 2012
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with an exudative (as defined by Light's criteria) pleural effusion of unknown etiology after a microbiological (namely gram stain and acid fast bacillus stain) and cytological examination
Who cannot join
- Significant hypoxemia on room air
- Hemodynamic instability
- Significant cardiac disease (known myocardial infarction in last 6 weeks or presence of unstable angina)
- Refractory cough
- Lack of pleural space due to adhesions
- Uncorrected coagulopathy
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
About this study
Official title: A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument designed for the same purpose which is claimed to be more user-friendly. The two devices have not been compared in a head-to-head trial in published literature. The investigators attempt to conduct a randomised comparative trial between the two devices.
- Conditions
- Pleurisy With Effusion
- Being tested
- Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany), Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)
- Keywords
- Pleural effusion, Semirigid thoracoscopy, Rigid thoracoscopy
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)Device
Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany
Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)Device
Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan
| Study group | Role | What they receive |
|---|---|---|
| Rigid thoracoscopy | Active comparator | Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany. Receives: Device: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany) |
| Semirigid thoracoscopy | Active comparator | The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan. Receives: Device: Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of thoracoscopic biopsy by intention to treat analysis
The proportion of patients where thoracoscopic pleural biopsy yielded a diagnosis that was consistent with the present clinical picture and the further follow-up of the patients, would be calculated and compared between the two arms
Measured: 3 months
Secondary outcomes (4)
Yield of biopsies successfully completed
The diagnostic yield of only those procedures would be considered separately where a biopsy could be successfully done and compared between the two arms
Measured: 3 months
Complications
Number of major and minor complications encountered in the two arms
Measured: 3 months
Scar size
Scar size (in mm) in the longest axis
Measured: At the end of the procedure
Biopsy size
Biopsy size (in mm) in the longest axis
Measured: At the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
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 Pleurisy With 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahajal Dhooria, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Ritesh Agarwal, MD, DM, Principal investigator, PGIMER, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726556
- Sponsor's protocol ID
- 1Trg-PG-2012/5054
- Acronym
- RISE
- Status last verified
- Jan 2013
- First submitted
- 7 Nov 2012
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dhooria S, Singh N, Aggarwal AN, Gupta D, Agarwal R. A randomized trial comparing the diagnostic yield of rigid and semirigid thoracoscopy in undiagnosed pleural effusions. Respir Care. 2014 May;59(5):756-64. doi: 10.4187/respcare.02738. Epub 2013 Oct 8.
PubMed 24106326
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
- ClinicalTrials.gov ID
- NCT01726556
- Acronym / sponsor ID
- RISE / 1Trg-PG-2012/5054
- Conditions
- Pleurisy With Effusion
- Keywords
- Pleural effusion, Semirigid thoracoscopy, Rigid thoracoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Nov 2012 (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.
Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument designed for the same purpose which is claimed to be more user-friendly. The two devices have not been compared in a head-to-head trial in published literature. The investigators attempt to conduct a randomised comparative trial between the two devices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rigid thoracoscopy | Active comparator | Device: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany. |
| Semirigid thoracoscopy | Active comparator | Device: Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with an exudative (as defined by Light's criteria) pleural effusion of unknown etiology after a microbiological (namely gram stain and acid fast bacillus stain) and cytological examination
Key exclusion criteria (6 listed)
- Significant hypoxemia on room air
- Hemodynamic instability
- Significant cardiac disease (known myocardial infarction in last 6 weeks or presence of unstable angina)
- Refractory cough
- Lack of pleural space due to adhesions
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 |
|---|---|---|
| Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany | Device | Rigid thoracoscopy |
| Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan | Device | Semirigid thoracoscopy |
Primary outcome
Diagnostic yield of thoracoscopic biopsy by intention to treat analysis
Time frame: 3 months
The proportion of patients where thoracoscopic pleural biopsy yielded a diagnosis that was consistent with the present clinical picture and the further follow-up of the patients, would be calculated and compared between the two arms
4 secondary outcomes
Yield of biopsies successfully completed
Time frame: 3 months
Complications
Time frame: 3 months
Scar size
Time frame: At the end of the procedure
Biopsy size
Time frame: At the end of the procedure
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 10 Jan 2013.
- Derived from this study: PubMed 24106326Dhooria S, Singh N, Aggarwal AN, Gupta D, Agarwal R. A randomized trial comparing the diagnostic yield of rigid and semirigid thoracoscopy in undiagnosed pleural effusions. Respir Care. 2014 May;59(5):756-64. doi: 10.4187/respcare.02738. Epub 2013 Oct 8.
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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.
Ritesh Agarwal, MD, DM principal investigator
PGIMER, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany) and Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan) in people with Pleurisy With Effusion, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 1 inclusion and 6 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 10 Jan 2013. 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 India. 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.
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 yield of thoracoscopic biopsy by intention to treat analysis (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 NCT01726556, 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 10 Jan 2013.