Pleural EffusionFLEXPLEURNCT06162429
Medical Thoracoscopy With Flexible Bronchoscopy Versus Semi-Rigid Pleuroscope in Pleural Effusion (FLEXPLEUR)
An observational study of Pleural Effusion, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Pleural effusion is a common problem in hospital patients. It may arise from a wide range of diseases. There is a multitude of recognised causes of pleural effusion, and in addition, other pleural conditions such as pleural thickening and pneumothorax represent a significant burden to the healthcare system and to… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Flexible Bronchoscopy and Semi-Rigid Pleuroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 188 participants
- Where
- 1 siteMalaysia
- Study dates
- 31 Jan 2024to 1 Nov 2024
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects admitted for pleural effusion who underwent a single MT with flexible bronchoscopy or semi-rigid pleuroscopy.
Who may be able to join
- Age 18 years and above
- Subjects admitted to Faculty of Medicine UKM during the study period and underwent a single MT with flexible bronchoscopy or semi-rigid pleuroscopy.
Who cannot join
- Age < 18 years.
- Patients with incomplete data
- Patients' medical record that cannot be retrieved.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
National University of Malaysia
Kuala Lumpur, Kuala Lumpur, 56000
About this study
Official title: Comparison of Diagnostic Yield and Complication of Medical Thoracoscopy Using Flexible Bronchoscope Versus Semi-Rigid Pleuroscope Among Hospitalized Patients With Pleural Effusion
Pleural effusion is a common problem in hospital patients. It may arise from a wide range of diseases. There is a multitude of recognised causes of pleural effusion, and in addition, other pleural conditions such as pleural thickening and pneumothorax represent a significant burden to the healthcare system and to patients. However, the diagnosis of this condition may sometimes be difficult. In pleural effusions undiagnosed by thoracocentesis, closed pleural biopsy increases the yield by ∼10% and 40%, respectively, in malignant and tuberculous pleural effusions, whereas the diagnostic yield of thoracoscopy is ∼93% in both malignant and tuberculous pleural effusions. Hence, medical thoracoscopy (MT) (pleuroscopy) is the gold standard in the diagnosis of pleural effusion and it is indicated when less invasive tests have failed. MT is a procedure in which the pleura is directly and visually examined. An endoscope is inserted into the intercostal space by creating a pneumothorax with an incision through the chest wall. The pleural space and its lining can be inspected and therapeutic interventions performed.
There are two different techniques that can be performed for diagnostic and therapeutic thoracoscopy. One method recommends a single-entry site, the use of a usually 9-mm rigid thoracoscope (or of a semi-rigid/semi-flexible 7-mm pleuroscope) with a working channel for accessory instruments and an optical biopsy forceps, both performed under local anaesthesia. The other method requires two entry sites: one for a 7-mm trocar for the examination telescope, and the other for a 5-mm trocar for accessory instruments including the biopsy forceps, and is usually performed with conscious sedation or general anaesthesia.
Read more
In the trained hands of a pulmonologist, MT is a safe and effective procedure for diagnosing and treating multiple pleural diseases. Valsecchi et al reported a pathological diagnostic yield of 71% over a span of 30 years in around 2000 patients. The unfamiliarity of the pulmonary physician with the rigid instrument and familiarity with the flexible bronchoscope has led various investigators to attempt thoracoscopy even with a fibreoptic bronchoscope.
The use of a flexible fibreoptic instrument to examine the pleural space was reported by Senno et al in the 1970s in the United States. Studies showed that flexible bronchoscope, when used as a thoracoscope, maintains a clear optical field by allowing concurrent suctioning, which is analogous to the suction techniques used during flexible bronchoscopy and better views at the apex and paravertebral gutters.This method is, therefore, considered to be useful for surgeons or physicians with experience in chest drainage and flexible bronchoscopy as well as safe and well tolerated with a minimal degree of discomfort and expense.
Read the detailed description
RESEARCH QUESTION Can Medical thorascopy using a flexible bronchoscope be used as an alternative method to a semi-rigid pleuroscopy for diagnosis of pleural effusion with a comparable outcome?
RESEARCH HYPOTHESES
- No difference in the diagnostic yield between flexible bronchoscopy and semi-rigid pleuroscopy
- No difference in the complication rate between flexible bronchoscopy and semi-rigid pleuroscopy
- Duration of procedure in flexible bronchoscopy is longer compared to semi-rigid pleuroscopy.
- The predictors of diagnostic yield in flexible bronchoscopy are similar to semi-rigid pleroscopy.
- No difeference in the specimen size taken from flexible bronchoscopy versus semi-rigid pleuroscopy
NOVELTY This is first study in Malaysia that we know of that has attempted to evaluate the diagnostic yield of medical thoracosopy using flexible bronchoscope and its complications. This study may be used to see whether there is a suitable alternative for respiratory physician to safely diagnosed pleural disease after a failed non-invasive procedure. While conventional medical thoracoscopy is the more expensive procedure, the true difference in procedure-related costs associated with flexible bronchoscope compared to semi-rigid pleuroscope is unknown due to the lack of cost-analysis study. Perhaps this study can provide the basis for future study to analyse the true cost-benefit of using flexible bronchoscope in medical thoracoscopy.
RESEARCH OBJECTIVES
GENERAL OBJECTIVE To compare the diagnostic yield, complication and duration of MT using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
SPECIFIC OBJECTIVES
- To compare the type of complication using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
- To compare the rate of complication using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
- To compare the duration of procedure using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
- To determine the predictors of diagnostic yield of flexible bronchoscope in hospital patients with pleural effusion.
- To compare the size of biopsy samples from flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
SIGNIFICANCE OF RESEARCH This research proposal is important to improve the diagnosis of hospital patients presenting with pleural effusion in Malaysia. Semi-rigid pleuroscope is expensive and not widely available, whereas flexible bronchoscope is more readily available and can be used as an alternative for medical thoracoscopic pleural biopsy. There is no previous study looking at diagnostic yield comparison between flexible bronchoscope and semi-rigid pleuroscope. This study could potentially serve as a feasibility study that can help future investigators prepare for full-scale research leading to intervention.
- Conditions
- Pleural Effusion
- Being tested
- Flexible Bronchoscopy, Semi-Rigid Pleuroscopy
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible BronchoscopyProcedure or surgery
Subjects with pleural effusion who underwent medical thoracoscopy using flexible bronchoscopy
Semi-Rigid PleuroscopyProcedure or surgery
Subjects with pleural effusion who underwent medical thorascopy using semi-rigid pleuroscopy
| Study group | Role | What they receive |
|---|---|---|
| Flexible Thoracoscopy | Subjects with pleural effusion who underwent medical thoracoscopy using flexible bronchoscopy in the Respiratory Unit, Department of Internal Medicine, Faculty of Medicine UKM Receives: Procedure: Flexible Bronchoscopy | |
| Semi-Rigid Pleuroscopy | Subjects with pleural effusion who underwent semi-rigid pleuroscopy using flexible bronchoscopy in the Respiratory Unit, Department of Internal Medicine, Faculty of Medicine UKM Receives: Procedure: Semi-Rigid Pleuroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the diagnostic yield (in percentage) using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
Subjects underwent medical thoracoscopy and the purpose is to compare the diagnostic yield, complication and duration of MT using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
Measured: between October 2017 to October 2022
Secondary outcomes (3)
To compare the rate of complication (in percentage) using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
Subjects underwent medical thoracoscopy and the purpose is to compare the rate of complication using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
Measured: between October 2017 to October 2022
To compare the duration of procedure (in minutes) using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
Subjects underwent medical thoracoscopy and the purpose is to compare the duration of procedure using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
Measured: between October 2017 to October 2022
To determine the predictors of diagnostic yield of flexible bronchoscope in hospital patients with pleural effusion
Subjects underwent medical thoracoscopy and the purpose is to determine the predictors of diagnostic yield of flexible bronchoscope in hospital patients with pleural effusion
Measured: between October 2017 to October 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start31 Jan 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Faisal Abdul Hamid, MBBS (IIUM), Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162429
- Sponsor's protocol ID
- FF-2023-128
- Acronym
- FLEXPLEUR
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diagnostic Yield and Complication of Medical Thoracoscopy Using Flexible Bronchoscope Versus Semi-Rigid Pleuroscope Among Hospitalized Patients With Pleural Effusion
- ClinicalTrials.gov ID
- NCT06162429
- Acronym / sponsor ID
- FLEXPLEUR / FF-2023-128
- Conditions
- Pleural Effusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 8 Dec 2023 (actual)
- 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.
Pleural effusion is a common problem in hospital patients. It may arise from a wide range of diseases. There is a multitude of recognised causes of pleural effusion, and in addition, other pleural conditions such as pleural thickening and pneumothorax represent a significant burden to the healthcare system and to patients. However, the diagnosis of this condition may sometimes be difficult. In pleural effusions undiagnosed by thoracocentesis, closed pleural biopsy increases the yield by ∼10% and 40%, respectively, in malignant and tuberculous pleural effusions, whereas the diagnostic yield of thoracoscopy is ∼93% in both malignant and tuberculous pleural effusions. Hence, medical thoracoscopy (MT) (pleuroscopy) is the gold standard in the diagnosis of pleural effusion and it is indicated when less invasive tests have failed. MT is a procedure in which the pleura is directly and visually examined. An endoscope is inserted into the intercostal space by creating a pneumothorax with an incision through the chest wall. The pleural space and its lining can be inspected and therapeutic interventions performed.
There are two different techniques that can be performed for diagnostic and therapeutic thoracoscopy. One method recommends a single-entry site, the use of a usually 9-mm rigid thoracoscope (or of a semi-rigid/semi-flexible 7-mm pleuroscope) with a working channel for accessory instruments and an optical biopsy forceps, both performed under local anaesthesia. The other method requires two entry sites: one for a 7-mm trocar for the examination telescope, and the other for a 5-mm trocar for accessory instruments including the biopsy forceps, and is usually performed with conscious sedation or general anaesthesia.
In the trained hands of a pulmonologist, MT is a safe and effective procedure for diagnosing and treating multiple pleural diseases. Valsecchi et al reported a pathological diagnostic yield of 71% over a span of 30 years in around 2000 patients. The unfamiliarity of the pulmonary physician with the rigid instrument and familiarity with the flexible bronchoscope has led various investigators to attempt thoracoscopy even with a fibreoptic bronchoscope.
The use of a flexible fibreoptic instrument to examine the pleural space was reported by Senno et al in the 1970s in the United States. Studies showed that flexible bronchoscope, when used as a thoracoscope, maintains a clear optical field by allowing concurrent suctioning, which is analogous to the suction techniques used during flexible bronchoscopy and better views at the apex and paravertebral gutters.This method is, therefore, considered to be useful for surgeons or physicians with experience in chest drainage and flexible bronchoscopy as well as safe and well tolerated with a minimal degree of discomfort and expense.
Detailed description
RESEARCH QUESTION Can Medical thorascopy using a flexible bronchoscope be used as an alternative method to a semi-rigid pleuroscopy for diagnosis of pleural effusion with a comparable outcome?
RESEARCH HYPOTHESES
- No difference in the diagnostic yield between flexible bronchoscopy and semi-rigid pleuroscopy
- No difference in the complication rate between flexible bronchoscopy and semi-rigid pleuroscopy
- Duration of procedure in flexible bronchoscopy is longer compared to semi-rigid pleuroscopy.
- The predictors of diagnostic yield in flexible bronchoscopy are similar to semi-rigid pleroscopy.
- No difeference in the specimen size taken from flexible bronchoscopy versus semi-rigid pleuroscopy
NOVELTY This is first study in Malaysia that we know of that has attempted to evaluate the diagnostic yield of medical thoracosopy using flexible bronchoscope and its complications. This study may be used to see whether there is a suitable alternative for respiratory physician to safely diagnosed pleural disease after a failed non-invasive procedure. While conventional medical thoracoscopy is the more expensive procedure, the true difference in procedure-related costs associated with flexible bronchoscope compared to semi-rigid pleuroscope is unknown due to the lack of cost-analysis study. Perhaps this study can provide the basis for future study to analyse the true cost-benefit of using flexible bronchoscope in medical thoracoscopy.
RESEARCH OBJECTIVES
GENERAL OBJECTIVE To compare the diagnostic yield, complication and duration of MT using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
SPECIFIC OBJECTIVES
- To compare the type of complication using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
- To compare the rate of complication using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
- To compare the duration of procedure using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
- To determine the predictors of diagnostic yield of flexible bronchoscope in hospital patients with pleural effusion.
- To compare the size of biopsy samples from flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
SIGNIFICANCE OF RESEARCH This research proposal is important to improve the diagnosis of hospital patients presenting with pleural effusion in Malaysia. Semi-rigid pleuroscope is expensive and not widely available, whereas flexible bronchoscope is more readily available and can be used as an alternative for medical thoracoscopic pleural biopsy. There is no previous study looking at diagnostic yield comparison between flexible bronchoscope and semi-rigid pleuroscope. This study could potentially serve as a feasibility study that can help future investigators prepare for full-scale research leading to intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible Thoracoscopy | – | Procedure: Flexible BronchoscopySubjects with pleural effusion who underwent medical thoracoscopy using flexible bronchoscopy in the Respiratory Unit, Department of Internal Medicine, Faculty of Medicine UKM |
| Semi-Rigid Pleuroscopy | – | Procedure: Semi-Rigid PleuroscopySubjects with pleural effusion who underwent semi-rigid pleuroscopy using flexible bronchoscopy in the Respiratory Unit, Department of Internal Medicine, Faculty of Medicine UKM |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects admitted for pleural effusion who underwent a single MT with flexible bronchoscopy or semi-rigid pleuroscopy.
Key inclusion criteria (2 listed)
- Age 18 years and above
- Subjects admitted to Faculty of Medicine UKM during the study period and underwent a single MT with flexible bronchoscopy or semi-rigid pleuroscopy.
Key exclusion criteria (3 listed)
- Age < 18 years.
- Patients with incomplete data
- Patients' medical record that cannot be retrieved.
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 |
|---|---|---|
| Flexible BronchoscopySubjects with pleural effusion who underwent medical thoracoscopy using flexible bronchoscopy | Procedure or surgery | Flexible Thoracoscopy |
| Semi-Rigid PleuroscopySubjects with pleural effusion who underwent medical thorascopy using semi-rigid pleuroscopy | Procedure or surgery | Semi-Rigid Pleuroscopy |
Primary outcome
To compare the diagnostic yield (in percentage) using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
Time frame: between October 2017 to October 2022
Subjects underwent medical thoracoscopy and the purpose is to compare the diagnostic yield, complication and duration of MT using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
3 secondary outcomes
To compare the rate of complication (in percentage) using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
Time frame: between October 2017 to October 2022
To compare the duration of procedure (in minutes) using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.
Time frame: between October 2017 to October 2022
To determine the predictors of diagnostic yield of flexible bronchoscope in hospital patients with pleural effusion
Time frame: between October 2017 to October 2022
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 7 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Mohamed Faisal Abdul Hamid, MBBS (IIUM) principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion, run by National University of Malaysia at 1 site in Malaysia.
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 2 inclusion and 3 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 7 Nov 2024. 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 Malaysia. 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?
To compare the diagnostic yield (in percentage) using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion. (time frame: between October 2017 to October 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2024.