An interventional study of Single-Use Flexible Bronchoscope and Semi-Rigid Pleuroscope in Malignant Pleural Effusions (Mpe), Medical Thoracoscopy and Pleural Effusion, sponsored by National University of Malaysia. Recruiting at 2 sites in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by National University of Malaysia · Not applicable, Interventional, and Diagnostic
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.
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
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.
169 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.
This study's planned enrollment of 36 is below the median of 55 across 125 interventional studies indexed under Pleural Effusion, Malignant.
Browse Pleural Effusion, Malignant studies →National University of Malaysia is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Semi-Rigid Pleuroscope
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.
Device: Single-Use Flexible Bronchoscope
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.
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.
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%
Time frame: Baseline up to 48 hours post-procedure
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.
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
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.
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
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.
Time frame: 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.
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
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
Time frame: Baseline up to 48 hours post-procedure
PDFs hosted by the registry, ClinicalTrials.gov.
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