Malignant Pleural Effusions (Mpe)FLEXPLEUR2NCT07726784
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
A study testing Single-Use Flexible Bronchoscope and Semi-Rigid Pleuroscope in people with Malignant Pleural Effusions (Mpe) and Medical Thoracoscopy, run by National University of Malaysia at 2 sites 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 years and older
- Conditions the study is for
- Malignant Pleural Effusions (Mpe), Medical Thoracoscopy, Pleural Effusion
- What is being tested?
- Single-Use Flexible Bronchoscope and Semi-Rigid Pleuroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesMalaysia
- Study dates
- 20 Aug 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age > 18 years
- Patient presents with an undifferentiated pleural effusion with or without initial diagnostic thoracocentesis, thereby necessitating definitive pleural tissue sampling.
- Demonstrated presence of a visually significant pleural effusion occupying at least one-third of the affected hemithorax on standard chest radiography, or a visually confirmed loculated effusion accessible via thoracic ultrasound mapping.
- The patient has demonstrated full willingness to participate and has signed the formal written informed consent form approved by the institutional review board.
Who cannot join
- Age < 18 years
- Patients with contraindications to perform medical thoracoscopy, e.g.:
- Uncorrectable coagulopathy (e.g., platelet count <50,000/µL, INR >1.5 despite correction)
- Severe hypoxemia not correctable with supplemental oxygen
- Hemodynamic instability
- Extensive pleural adhesions or obliterated pleural space on imaging
Show all 12Show fewer
- Uncontrolled cardiac arrhythmia or recent acute coronary syndrome
- Severe pulmonary hypertension with high procedural risk
- Inability to tolerate lateral decubitus position
- Refusal to provide informed consent
- Pregnancy
- Previous ipsilateral pleurodesis or thoracic surgery significantly altering pleural anatomy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia2 sites, 2 recruiting
- Recruiting
Hospital Canselor Tuanku Muhriz, National University of Malaysia,
Cheras, Kuala Lumput, 56000
Mohamed Faisal Abdul Hamid, MBBS(IIUM), +603-91456082 ext. 6597, faisal.hamid@ppukm.ukm.edu.my
- Recruiting
Faculty of Medicine, Hospital CAnselor Tuanku Muhriz UKM
Kuala Lumpur, Kuala Lumpur, 56000
Mohamed Faisal Abdul Hamid, MBBS
About this study
Official title: A Pilot Randomized Controlled Trial Comparing Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope Among Hospitalized Patients With Pleural Effusion (FLEXPLEUR2)
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 provides limited yield, whereas the diagnostic yield of thoracoscopy is substantially higher for 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 rigid thoracoscope (or of a semi-rigid/semi-flexible 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 trocar for the examination telescope, and the second 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. The unfamiliarity of the pulmonary physician with rigid instruments and familiarity with the flexible bronchoscope has led various investigators to attempt thoracoscopy with flexible endoscopes.
Flexible instruments allow concurrent suctioning to maintain a clear optical field, providing good views at the apex and paravertebral gutters. This method is considered useful for 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 MT using a disposable flexible bronchoscope be used as an alternative method to a semi-rigid pleuroscope for diagnosis of pleural effusion with a comparable outcome?
Research Hypotheses
- Medical thoracoscopy using a single-use flexible bronchoscope is feasible, defined by successful entry into the pleural space, adequate pleural visualization, successful pleural biopsy acquisition, and completion of the procedure without conversion to conventional semi-rigid pleuroscopy.
- There is no significant difference in the total duration of the procedure (in minutes) between medical thoracoscopy performed using the single-use flexible bronchoscope and the conventional semi-rigid pleuroscope.
- Medical thoracoscopy using a single-use flexible bronchoscope is operationally feasible, showing no significant difference in procedural success rates-defined as successful entry into the pleural space, adequate visualization, and successful tissue collection without requiring device crossover-when compared to the conventional semi-rigid pleuroscope.
- The immediate procedural cost-utilization and disposable hardware expenditures associated with the single-use flexible bronchoscope arm will be different from (or lower than) the conventional semi-rigid pleuroscope arm.
- There is no significant difference in the preliminary baseline diagnostic yields or the 48-hour post-procedural complication rates and profiles between the single-use flexible bronchoscope group and the conventional semi-rigid pleuroscope group.
Study Design This is a prospective, single-centre, open-label, two-arm parallel-group randomized controlled trial comparing disposable flexible bronchoscopy versus semi-rigid pleuroscopy among hospital patients with pleural effusion.
Study Setting The study will be conducted in the Endoscopy Centre, Hospital Canselor Tuanku Muhriz UKM (HCTM UKM).
Sample Size The target sample size for this pilot parallel-group study is 36 subjects in total, randomized in a 1:1 ratio into two comparative arms: the Flexible Single-Use Bronchoscopy Group (n=18) and the Conventional Semi-Rigid Pleuroscopy Group (n=18).
Study Protocol All patients referred for medical thoracoscopy who fulfill the study inclusion and exclusion criteria will be screened for eligibility. Eligible patients will be approached by the study investigators and provided with detailed information regarding the study. Written informed consent will be obtained prior to enrolment. The decision to perform medical thoracoscopy will be made independently by the treating respiratory specialist based on routine clinical indications prior to study enrolment. The research intervention is limited to the allocation of the thoracoscopic device used during the procedure and does not alter the patient's standard clinical management. The study intervention consists solely of allocation to either the investigational device (UE Medical Single-Use Flexible Bronchoscope) or the standard-of-care comparator device (Olympus Semi-Rigid Pleuroscope), while all other aspects of patient management remain unchanged.
Following consent, participants will be randomized in a 1:1 ratio using block randomization to either the Single-Use Flexible Bronchoscope Group or the Conventional Semi-Rigid Pleuroscope Group. Participants who decline the allocated intervention after randomization will be withdrawn from the study and managed according to standard clinical practice. Their withdrawal will be documented, and no further study-specific data will be collected.
All procedures will be performed under local anaesthesia with conscious sedation according to institutional protocols. Procedures will be conducted by a respiratory specialist experienced in pleural interventions who has independently performed over fifty (50) medical thoracoscopy procedures. To ensure procedural consistency, standardization, and patient safety, an additional respiratory specialist will be present within the unit as an observer during the procedure.
After establishment of pleural access and insertion of the trocar, the allocated endoscope will be introduced into the pleural cavity. A systematic examination of the pleural space will then be performed, including inspection of the parietal pleura, visceral pleura, diaphragm, and accessible pleural surfaces. To ensure adequate visualization, all four layers of parietal pleura (costal, mediastinal, diaphragmatic, and cervical pleura) must be visualized according to the standard reporting checklist. Any abnormal pleural lesions, nodules, thickening, adhesions, or suspicious areas will be identified and targeted for biopsy.
Procedure duration will be measured from the time the endoscope enters the pleural cavity through the trocar until complete removal of the endoscope from the trocar at the end of the procedure. This duration will be recorded in minutes for subsequent analysis.
Pleural biopsy specimens will be obtained using standard biopsy forceps through the working channel of the allocated device. To ensure uniformity of tissue sampling between both study arms, a minimum of ten (10) adequate pleural biopsy specimens will be obtained whenever technically feasible and clinically safe. An adequate pleural biopsy specimen is defined as a tissue sample deemed macroscopically satisfactory by the operator and suitable for histopathological assessment. Additional biopsies may be obtained at the discretion of the operator if clinically indicated.
In the event of technical difficulties, inadequate visualization, inability to obtain satisfactory tissue samples, equipment failure, or any circumstance that may compromise patient safety, crossover to the alternative device will be permitted at the discretion of the operator. The reason for crossover will be documented and included in the final analysis.
Upon completion of the procedure, a chest drain will be inserted according to standard institutional practice. Pleural fluid and biopsy specimens will be submitted for histopathological, microbiological, cytological, and other relevant investigations as clinically indicated. Patients will be monitored during the procedure and for at least 48 hours thereafter for any procedure-related complications.
Data collected will include demographic characteristics, procedural duration, procedural success, need for crossover, diagnostic yield, complications, and immediate post-procedural outcomes. All data will be recorded using standardized case report forms and entered into a secure study database for analysis.
- Being tested
- Single-Use Flexible Bronchoscope, Semi-Rigid Pleuroscope
- Keywords
- PLEURAL EFFUSION, MEDICAL THORACOSCOPY
- Medical subject headings
- Pleural Effusion, Malignant, Myeloproliferative Disorder, Chronic, with Eosinophilia, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Use Flexible BronchoscopeDevice
The investigational device evaluated in this study is the UE Medical Single-Use Flexible Bronchoscope, a sterile disposable flexible endoscope equipped with a 2.8-mm working channel. The device is designed to visualize the pleural cavity and permit pleural tissue sampling with standard biopsy forceps during medical thoracoscopy.
Both devices are intended to achieve the same clinical objectives, namely pleural cavity inspection and pleural tissue sampling. The primary difference is that the investigational device is a single-use, disposable, flexible bronchoscope, whereas the comparator is a reusable, semi-rigid pleuroscope routinely used in clinical practice.
Semi-Rigid PleuroscopeDevice
The comparator device is the Olympus LTF-260 Semi-Rigid Pleuroscope, which represents the current standard-of-care instrument used for medical thoracoscopy at Hospital Canselor Tuanku Muhriz (HCTM) UKM. The semi-rigid pleuroscope features a flexible distal tip and a 2.8-mm working channel, enabling visualization of the pleural cavity and tissue acquisition during pleural biopsy.
Both devices are intended to achieve the same clinical objectives, namely pleural cavity inspection and pleural tissue sampling. The primary difference is that the investigational device is a single-use, disposable, flexible bronchoscope, whereas the comparator is a reusable, semi-rigid pleuroscope routinely used in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Semi-Rigid Pleuroscope | Active comparator | The comparator device is the Olympus LTF-260 Semi-Rigid Pleuroscope, which represents the current standard-of-care instrument used for medical thoracoscopy at Hospital Canselor Tuanku Muhriz (HCTM) UKM. The semi-rigid pleuroscope features a flexible distal tip and a 2.8-mm working channel, enabling visualization of the pleural cavity and tissue acquisition during pleural biopsy. Receives: Device: Semi-Rigid Pleuroscope |
| Single-Use Flexible Bronchoscope | Experimental | The investigational device evaluated in this study is the UE Medical Single-Use Flexible Bronchoscope, a sterile disposable flexible endoscope equipped with a 2.8-mm working channel. The device is designed to visualize the pleural cavity and permit pleural tissue sampling with standard biopsy forceps during medical thoracoscopy. Receives: Device: Single-Use Flexible Bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility rate (in percentage) of medical thoracoscopy using a single-use flexible bronchoscope compared with the conventional semi-rigid pleuroscope
Reported as a single percentage: the proportion of trial cases meeting 100% of defined feasibility criteria.
Individual measures (recruitment consent, intervention delivery, protocol adherence, technical pleural entry including visualization and biopsy, procedural completion without crossover, and 48-hour follow-up) will be evaluated per participant.
The final reported value is calculated as:
Overall Feasibility Rate (%)= Number of participants meeting all 7 feasibility criteria ÷ Total number of enrolled participants X 100%
Measured: Baseline up to 48 hours post-procedure
Secondary outcomes (5)
Difference in procedure duration (in minutes) between the single-use flexible bronchoscope and the conventional semi-rigid pleuroscope to evaluate time-efficiency.
Total duration of the medical thoracoscopy procedure in minutes, measured from the time the videoscope enters the pleural cavity through the trocar until complete removal of the videoscope from the trocar at the end of the procedure. This duration will be recorded in minutes for analysis.
Measured: During the procedure (From 30 to 60 minutes)
Procedural success rate (in percentage) between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope
The percentage of participants in each treatment group achieving procedural success, defined as successful entry into the pleural space and adequate tissue sample collection without requiring device crossover.
Measured: During the procedure (approximately 30 to 60 minutes)
Difference in immediate procedural and disposable hardware costs between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope
Total cost per participant for single-use devices, disposables, and procedural equipment, tracked via standard trial micro-costing inventory sheets at the time of procedure.
Measured: During procedure execution (up to 2 hours)
Diagnostic Yield Rate (in percentage) between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope
The percentage of participants in each group for whom pleural biopsy samples yielded a definitive histopathological or microbiological diagnosis.
Measured: From time of procedure through final pathology report release (up to 14 days post-procedure)
Incidence of Immediate Treatment-Related Adverse Events Within 48 Hours between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope
The proportion (in percentage) of participants in each group who develop immediate procedure-related adverse events, comparing the single-use flexible bronchoscope group to the conventional semi-rigid pleuroscope group, measured by clinical chart review
Measured: Baseline up to 48 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start20 Aug 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural Effusions (Mpe)Studies 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
- Parallel groups
- Model description
- Investigational Product: The investigational device evaluated in this study is the UE Medical Single-Use Flexible Bronchoscope, a sterile disposable flexible endoscope equipped with a 2.8-mm working channel. The device is designed to visualize the pleural cavity and permit pleural tissue sampling with standard biopsy forceps during medical thoracoscopy. Comparator (Standard of Care) The comparator device is the Olympus LTF-260 Semi-Rigid Pleuroscope, which represents the current standard-of-care instrument used for medical thoracoscopy at Hospital Canselor Tuanku Muhriz (HCTM) UKM. The semi-rigid pleuroscope features a flexible distal tip and a 2.8-mm working channel, enabling visualization of the pleural cavity and tissue acquisition during pleural biopsy. The primary difference is that the investigational device is a single-use, disposable, flexible bronchoscope, whereas the comparator is a reusable, semi-rigid pleuroscope routinely used in clinical practice.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
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, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726784
- Sponsor's protocol ID
- JEP-2026-204
- Acronym
- FLEXPLEUR2
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protect participant privacy
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 23418922Gwin E, Pierce G, Boggan M, Kerby G, Ruth W. Pleuroscopy and pleural biopsy with the flexible fiberoptic bronchoscope. Chest. 1975 May;67(5):527-31. doi: 10.1378/chest.67.5.527.
PubMed 1126188Senno A, Moallem S, Quijano ER, Adeyemo A, Clauss RH. Thoracoscopy with the fiberoptic bronchoscope. A simple method in diagnosing pleuropulmonary diseases. J Thorac Cardiovasc Surg. 1974 Apr;67(4):606-11. No abstract available.
PubMed 4818537Marchetti GP, Pinelli V, Tassi GF. 100 years of thoracoscopy: historical notes. Respiration. 2011;82(2):187-92. doi: 10.1159/000326066. Epub 2011 Apr 8.
PubMed 21474917Shamsuddin AR, Mohamad Jailaini MF, Azmel AA, Abdul Hamid MF. Comparison of diagnostic yield and complication of medical thoracoscopy using Flexible Bronchoscope versus Semi-Rigid Pleuroscope among Hospitalized Patients with Pleural Effusion (FLEXPLEUR): a retrospective observational study. J Thorac Dis. 2025 Jun 30;17(6):3631-3642. doi: 10.21037/jtd-2025-135. Epub 2025 Jun 9.
PubMed 40688315Manoharan A, Argaez C. Pleuroscopy for the Diagnosis of Cancer in Patients with Pleural Effusion: A Review of the Diagnostic Accuracy, Safety, Cost-Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2020 Apr 16. Available from http://www.ncbi.nlm.nih.gov/books/NBK563003/
PubMed 33074637Loddenkemper R, Boutin C. Thoracoscopy: present diagnostic and therapeutic indications. Eur Respir J. 1993 Nov;6(10):1544-55.
PubMed 8112449Boutin C, Cargnino P, Viallat JR. Thoracoscopy in the early diagnosis of malignant pleural effusions. Endoscopy. 1980 Jul;12(4):155-60. doi: 10.1055/s-2007-1021734. No abstract available.
PubMed 7398596Menzies R, Charbonneau M. Thoracoscopy for the diagnosis of pleural disease. Ann Intern Med. 1991 Feb 15;114(4):271-6. doi: 10.7326/0003-4819-114-4-271.
PubMed 1987873Yokoyama T, Toda R, Tomioka R, Aizawa H. Medical Thoracoscopy Performed Using a Flexible Bronchoscope Inserted through a Chest Tube under Local Anesthesia. Diagn Ther Endosc. 2009;2009:394817. doi: 10.1155/2009/394817. Epub 2009 Jun 7.
PubMed 19536345Davidson AC, George RJ, Sheldon CD, Sinha G, Corrin B, Geddes DM. Thoracoscopy: assessment of a physician service and comparison of a flexible bronchoscope used as a thoracoscope with a rigid thoracoscope. Thorax. 1988 Apr;43(4):327-32. doi: 10.1136/thx.43.4.327.
PubMed 3406921Fielding D, Hopkins P, Serisier D. Frozen section of pleural biopsies at medical thoracoscopy assists in correctly identifying benign disease. Respirology. 2005 Nov;10(5):636-42. doi: 10.1111/j.1440-1843.2005.00761.x.
PubMed 16268918Valsecchi A, Arondi S, Marchetti G. Medical thoracoscopy: Analysis on diagnostic yield through 30 years of experience. Ann Thorac Med. 2016 Jul-Sep;11(3):177-82. doi: 10.4103/1817-1737.185755.
PubMed 27512506Collins TR, Sahn SA. Thoracocentesis. Clinical value, complications, technical problems, and patient experience. Chest. 1987 Jun;91(6):817-22. doi: 10.1378/chest.91.6.817.
PubMed 3581930Maskell NA, Butland RJ; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the investigation of a unilateral pleural effusion in adults. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii8-17. doi: 10.1136/thorax.58.suppl_2.ii8. No abstract available.
PubMed 12728146
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Comparing Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope Among Hospitalized Patients With Pleural Effusion (FLEXPLEUR2)
- ClinicalTrials.gov ID
- NCT07726784
- Acronym / sponsor ID
- FLEXPLEUR2 / JEP-2026-204
- Keywords
- PLEURAL EFFUSION, MEDICAL THORACOSCOPY
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 24 Jul 2026 (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 provides limited yield, whereas the diagnostic yield of thoracoscopy is substantially higher for 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 rigid thoracoscope (or of a semi-rigid/semi-flexible 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 trocar for the examination telescope, and the second 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. The unfamiliarity of the pulmonary physician with rigid instruments and familiarity with the flexible bronchoscope has led various investigators to attempt thoracoscopy with flexible endoscopes.
Flexible instruments allow concurrent suctioning to maintain a clear optical field, providing good views at the apex and paravertebral gutters. This method is considered useful for 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 MT using a disposable flexible bronchoscope be used as an alternative method to a semi-rigid pleuroscope for diagnosis of pleural effusion with a comparable outcome?
Research Hypotheses
- Medical thoracoscopy using a single-use flexible bronchoscope is feasible, defined by successful entry into the pleural space, adequate pleural visualization, successful pleural biopsy acquisition, and completion of the procedure without conversion to conventional semi-rigid pleuroscopy.
- There is no significant difference in the total duration of the procedure (in minutes) between medical thoracoscopy performed using the single-use flexible bronchoscope and the conventional semi-rigid pleuroscope.
- Medical thoracoscopy using a single-use flexible bronchoscope is operationally feasible, showing no significant difference in procedural success rates-defined as successful entry into the pleural space, adequate visualization, and successful tissue collection without requiring device crossover-when compared to the conventional semi-rigid pleuroscope.
- The immediate procedural cost-utilization and disposable hardware expenditures associated with the single-use flexible bronchoscope arm will be different from (or lower than) the conventional semi-rigid pleuroscope arm.
- There is no significant difference in the preliminary baseline diagnostic yields or the 48-hour post-procedural complication rates and profiles between the single-use flexible bronchoscope group and the conventional semi-rigid pleuroscope group.
Study Design This is a prospective, single-centre, open-label, two-arm parallel-group randomized controlled trial comparing disposable flexible bronchoscopy versus semi-rigid pleuroscopy among hospital patients with pleural effusion.
Study Setting The study will be conducted in the Endoscopy Centre, Hospital Canselor Tuanku Muhriz UKM (HCTM UKM).
Sample Size The target sample size for this pilot parallel-group study is 36 subjects in total, randomized in a 1:1 ratio into two comparative arms: the Flexible Single-Use Bronchoscopy Group (n=18) and the Conventional Semi-Rigid Pleuroscopy Group (n=18).
Study Protocol All patients referred for medical thoracoscopy who fulfill the study inclusion and exclusion criteria will be screened for eligibility. Eligible patients will be approached by the study investigators and provided with detailed information regarding the study. Written informed consent will be obtained prior to enrolment. The decision to perform medical thoracoscopy will be made independently by the treating respiratory specialist based on routine clinical indications prior to study enrolment. The research intervention is limited to the allocation of the thoracoscopic device used during the procedure and does not alter the patient's standard clinical management. The study intervention consists solely of allocation to either the investigational device (UE Medical Single-Use Flexible Bronchoscope) or the standard-of-care comparator device (Olympus Semi-Rigid Pleuroscope), while all other aspects of patient management remain unchanged.
Following consent, participants will be randomized in a 1:1 ratio using block randomization to either the Single-Use Flexible Bronchoscope Group or the Conventional Semi-Rigid Pleuroscope Group. Participants who decline the allocated intervention after randomization will be withdrawn from the study and managed according to standard clinical practice. Their withdrawal will be documented, and no further study-specific data will be collected.
All procedures will be performed under local anaesthesia with conscious sedation according to institutional protocols. Procedures will be conducted by a respiratory specialist experienced in pleural interventions who has independently performed over fifty (50) medical thoracoscopy procedures. To ensure procedural consistency, standardization, and patient safety, an additional respiratory specialist will be present within the unit as an observer during the procedure.
After establishment of pleural access and insertion of the trocar, the allocated endoscope will be introduced into the pleural cavity. A systematic examination of the pleural space will then be performed, including inspection of the parietal pleura, visceral pleura, diaphragm, and accessible pleural surfaces. To ensure adequate visualization, all four layers of parietal pleura (costal, mediastinal, diaphragmatic, and cervical pleura) must be visualized according to the standard reporting checklist. Any abnormal pleural lesions, nodules, thickening, adhesions, or suspicious areas will be identified and targeted for biopsy.
Procedure duration will be measured from the time the endoscope enters the pleural cavity through the trocar until complete removal of the endoscope from the trocar at the end of the procedure. This duration will be recorded in minutes for subsequent analysis.
Pleural biopsy specimens will be obtained using standard biopsy forceps through the working channel of the allocated device. To ensure uniformity of tissue sampling between both study arms, a minimum of ten (10) adequate pleural biopsy specimens will be obtained whenever technically feasible and clinically safe. An adequate pleural biopsy specimen is defined as a tissue sample deemed macroscopically satisfactory by the operator and suitable for histopathological assessment. Additional biopsies may be obtained at the discretion of the operator if clinically indicated.
In the event of technical difficulties, inadequate visualization, inability to obtain satisfactory tissue samples, equipment failure, or any circumstance that may compromise patient safety, crossover to the alternative device will be permitted at the discretion of the operator. The reason for crossover will be documented and included in the final analysis.
Upon completion of the procedure, a chest drain will be inserted according to standard institutional practice. Pleural fluid and biopsy specimens will be submitted for histopathological, microbiological, cytological, and other relevant investigations as clinically indicated. Patients will be monitored during the procedure and for at least 48 hours thereafter for any procedure-related complications.
Data collected will include demographic characteristics, procedural duration, procedural success, need for crossover, diagnostic yield, complications, and immediate post-procedural outcomes. All data will be recorded using standardized case report forms and entered into a secure study database for analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigational Product: The investigational device evaluated in this study is the UE Medical Single-Use Flexible Bronchoscope, a sterile disposable flexible endoscope equipped with a 2.8-mm working channel. The device is designed to visualize the pleural cavity and permit pleural tissue sampling with standard biopsy forceps during medical thoracoscopy. Comparator (Standard of Care) The comparator device is the Olympus LTF-260 Semi-Rigid Pleuroscope, which represents the current standard-of-care instrument used for medical thoracoscopy at Hospital Canselor Tuanku Muhriz (HCTM) UKM. The semi-rigid pleuroscope features a flexible distal tip and a 2.8-mm working channel, enabling visualization of the pleural cavity and tissue acquisition during pleural biopsy. The primary difference is that the investigational device is a single-use, disposable, flexible bronchoscope, whereas the comparator is a reusable, semi-rigid pleuroscope routinely used in clinical practice.
| Arm | Type | Receives |
|---|---|---|
| Semi-Rigid Pleuroscope | Active comparator | Device: Semi-Rigid PleuroscopeThe comparator device is the Olympus LTF-260 Semi-Rigid Pleuroscope, which represents the current standard-of-care instrument used for medical thoracoscopy at Hospital Canselor Tuanku Muhriz (HCTM) UKM. The semi-rigid pleuroscope features a flexible distal tip and a 2.8-mm working channel, enabling visualization of the pleural cavity and tissue acquisition during pleural biopsy. |
| Single-Use Flexible Bronchoscope | Experimental | Device: Single-Use Flexible BronchoscopeThe investigational device evaluated in this study is the UE Medical Single-Use Flexible Bronchoscope, a sterile disposable flexible endoscope equipped with a 2.8-mm working channel. The device is designed to visualize the pleural cavity and permit pleural tissue sampling with standard biopsy forceps during medical thoracoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Patient presents with an undifferentiated pleural effusion with or without initial diagnostic thoracocentesis, thereby necessitating definitive pleural tissue sampling.
- Demonstrated presence of a visually significant pleural effusion occupying at least one-third of the affected hemithorax on standard chest radiography, or a visually confirmed loculated effusion accessible via thoracic ultrasound mapping.
- The patient has demonstrated full willingness to participate and has signed the formal written informed consent form approved by the institutional review board.
Key exclusion criteria (12 listed)
- Age < 18 years
- Patients with contraindications to perform medical thoracoscopy, e.g.:
- Uncorrectable coagulopathy (e.g., platelet count <50,000/µL, INR >1.5 despite correction)
- Severe hypoxemia not correctable with supplemental oxygen
- Hemodynamic instability
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 |
|---|---|---|
| Single-Use Flexible BronchoscopeThe investigational device evaluated in this study is the UE Medical Single-Use Flexible Bronchoscope, a sterile disposable flexible endoscope equipped with a 2.8-mm working channel. The device is designed to visualize the pleural cavity and permit pleural tissue sampling with standard biopsy forceps during medical thoracoscopy. Both devices are intended to achieve the same clinical objectives, namely pleural cavity inspection and pleural tissue sampling. The primary difference is that the investigational device is a single-use, disposable, flexible bronchoscope, whereas the comparator is a reusable, semi-rigid pleuroscope routinely used in clinical practice. | Device | Single-Use Flexible Bronchoscope |
| Semi-Rigid PleuroscopeThe comparator device is the Olympus LTF-260 Semi-Rigid Pleuroscope, which represents the current standard-of-care instrument used for medical thoracoscopy at Hospital Canselor Tuanku Muhriz (HCTM) UKM. The semi-rigid pleuroscope features a flexible distal tip and a 2.8-mm working channel, enabling visualization of the pleural cavity and tissue acquisition during pleural biopsy. Both devices are intended to achieve the same clinical objectives, namely pleural cavity inspection and pleural tissue sampling. The primary difference is that the investigational device is a single-use, disposable, flexible bronchoscope, whereas the comparator is a reusable, semi-rigid pleuroscope routinely used in clinical practice. | Device | Semi-Rigid Pleuroscope |
Primary outcome
Feasibility rate (in percentage) of medical thoracoscopy using a single-use flexible bronchoscope compared with the conventional semi-rigid pleuroscope
Time frame: Baseline up to 48 hours post-procedure
Reported as a single percentage: the proportion of trial cases meeting 100% of defined feasibility criteria. Individual measures (recruitment consent, intervention delivery, protocol adherence, technical pleural entry including visualization and biopsy, procedural completion without crossover, and 48-hour follow-up) will be evaluated per participant. The final reported value is calculated as: Overall Feasibility Rate (%)= Number of participants meeting all 7 feasibility criteria ÷ Total number of enrolled participants X 100%
5 secondary outcomes
Difference in procedure duration (in minutes) between the single-use flexible bronchoscope and the conventional semi-rigid pleuroscope to evaluate time-efficiency.
Time frame: During the procedure (From 30 to 60 minutes)
Procedural success rate (in percentage) between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope
Time frame: During the procedure (approximately 30 to 60 minutes)
Difference in immediate procedural and disposable hardware costs between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope
Time frame: During procedure execution (up to 2 hours)
Diagnostic Yield Rate (in percentage) between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope
Time frame: From time of procedure through final pathology report release (up to 14 days post-procedure)
Incidence of Immediate Treatment-Related Adverse Events Within 48 Hours between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope
Time frame: Baseline up to 48 hours post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: 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.
- Background: PubMed 1126188Gwin E, Pierce G, Boggan M, Kerby G, Ruth W. Pleuroscopy and pleural biopsy with the flexible fiberoptic bronchoscope. Chest. 1975 May;67(5):527-31. doi: 10.1378/chest.67.5.527.
- Background: PubMed 4818537Senno A, Moallem S, Quijano ER, Adeyemo A, Clauss RH. Thoracoscopy with the fiberoptic bronchoscope. A simple method in diagnosing pleuropulmonary diseases. J Thorac Cardiovasc Surg. 1974 Apr;67(4):606-11. No abstract available.
- Background: PubMed 21474917Marchetti GP, Pinelli V, Tassi GF. 100 years of thoracoscopy: historical notes. Respiration. 2011;82(2):187-92. doi: 10.1159/000326066. Epub 2011 Apr 8.
- Background: PubMed 40688315Shamsuddin AR, Mohamad Jailaini MF, Azmel AA, Abdul Hamid MF. Comparison of diagnostic yield and complication of medical thoracoscopy using Flexible Bronchoscope versus Semi-Rigid Pleuroscope among Hospitalized Patients with Pleural Effusion (FLEXPLEUR): a retrospective observational study. J Thorac Dis. 2025 Jun 30;17(6):3631-3642. doi: 10.21037/jtd-2025-135. Epub 2025 Jun 9.
- Background: PubMed 33074637Manoharan A, Argaez C. Pleuroscopy for the Diagnosis of Cancer in Patients with Pleural Effusion: A Review of the Diagnostic Accuracy, Safety, Cost-Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2020 Apr 16. Available from http://www.ncbi.nlm.nih.gov/books/NBK563003/
- Background: PubMed 8112449Loddenkemper R, Boutin C. Thoracoscopy: present diagnostic and therapeutic indications. Eur Respir J. 1993 Nov;6(10):1544-55.
- Background: PubMed 7398596Boutin C, Cargnino P, Viallat JR. Thoracoscopy in the early diagnosis of malignant pleural effusions. Endoscopy. 1980 Jul;12(4):155-60. doi: 10.1055/s-2007-1021734. No abstract available.
- Background: PubMed 1987873Menzies R, Charbonneau M. Thoracoscopy for the diagnosis of pleural disease. Ann Intern Med. 1991 Feb 15;114(4):271-6. doi: 10.7326/0003-4819-114-4-271.
- Background: PubMed 19536345Yokoyama T, Toda R, Tomioka R, Aizawa H. Medical Thoracoscopy Performed Using a Flexible Bronchoscope Inserted through a Chest Tube under Local Anesthesia. Diagn Ther Endosc. 2009;2009:394817. doi: 10.1155/2009/394817. Epub 2009 Jun 7.
- Background: PubMed 3406921Davidson AC, George RJ, Sheldon CD, Sinha G, Corrin B, Geddes DM. Thoracoscopy: assessment of a physician service and comparison of a flexible bronchoscope used as a thoracoscope with a rigid thoracoscope. Thorax. 1988 Apr;43(4):327-32. doi: 10.1136/thx.43.4.327.
- Background: PubMed 16268918Fielding D, Hopkins P, Serisier D. Frozen section of pleural biopsies at medical thoracoscopy assists in correctly identifying benign disease. Respirology. 2005 Nov;10(5):636-42. doi: 10.1111/j.1440-1843.2005.00761.x.
- Individual participant dataSharing planned: No. Protect participant privacy
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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.
Mohamed Faisal Abdul Hamid, MBBS(IIUM) principal investigator
Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Use Flexible Bronchoscope and Semi-Rigid Pleuroscope in people with Malignant Pleural Effusions (Mpe) and Medical Thoracoscopy, run by National University of Malaysia at 2 sites 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Faisal Abdul Hamid, MBBS(IIUM) (+603-91456082 ext. 6597, faisal.hamid@hctm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility rate (in percentage) of medical thoracoscopy using a single-use flexible bronchoscope compared with the conventional semi-rigid pleuroscope (time frame: Baseline up to 48 hours post-procedure). 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 NCT07726784, which also lists 16 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 11 Sep 2026.