An interventional study of Dual-function semi-rigid thoracoscopy and Rigid thoracoscopy in Pleural Effusion Disorder, sponsored by China-Japan Friendship Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Diagnostic
Medical thoracoscopy (rigid and semirigid) is an effective, safe method for diagnosing and managing pleural diseases. Rigid thoracoscopy demonstrates superior overall diagnostic yield compared to semirigid techniques (flexible forceps/cryobiopsy) due to its ability to obtain larger, deeper biopsies with rigid forceps. However, diagnostic rates become similar when biopsies are successfully obtained.
Limitations of rigid thoracoscopy include restricted maneuverability (especially in posterior/mediastinal areas), increased procedural pain from leveraging against ribs and larger trocars, higher sedation requirements, and a steep learning curve for pulmonologists.
To address these issues, a novel dual-function semirigid thoracoscope (UE FET-680, China) was developed. Its straight working channel accommodates standard rigid biopsy forceps, potentially matching rigid thoracoscopy's diagnostic yield while improving usability. This randomized trial will compare the efficacy and safety of this new device versus conventional rigid thoracoscopy in undiagnosed exudative pleural effusions.
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 92 is above the median of 80 across 142 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →China-Japan Friendship Hospital is the lead sponsor of 178 studies on the registry; 111 are open to participants now.
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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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Dual-function semi-rigid thoracoscopy
Device: Rigid thoracoscopy
Patients received pleural biopsy via dual-function semi-rigid thoracoscopy.
Patients received pleural biopsy via rigid thoracoscopy.
Diagnostic yield
Diagnostic yield is defined as the percentage of participants for whom the allocated thoracoscopic pleural biopsy provides a specific histopathological diagnosis. Malignant pleural disease and other defined histopathological diagnoses will be classified as diagnostic results. Non-specific pleuritis, fibrinous pleuritis, non-interpretable specimens, and cases in which no biopsy is obtained will be classified as non-diagnostic results.
Time frame: 7 days after the procedure.
Procedural Sedative and Analgesic Requirements
Procedural sedative and analgesic requirements will be assessed by recording the total dose of each sedative or analgesic agent administered during thoracoscopy, including midazolam, pentazocine, and tramadol. The dose of each agent will be recorded separately in milligrams and summarised by treatment group
Time frame: The day of thoracoscopy.
Disease-specific Diagnostic Sensitivity
Disease-specific diagnostic sensitivity is defined as the percentage of participants with a specific final diagnosis according to the reference standard whose allocated thoracoscopic pleural biopsy provides a specific histopathological diagnosis supporting the same disease. Participants with non-specific biopsy findings who are subsequently diagnosed with malignant pleural disease or tuberculous pleuritis during follow-up will be classified as false-negative biopsy results for the corresponding disease.
Time frame: Up to 12 months after thoracoscopy.
Sampling Quality of Pleural Biopsy Specimens
Sampling quality will be assessed using specimen size, specimen depth, and specimen interpretability. Specimen size will be measured as the largest cross-sectional area of the processed biopsy specimens on microscopic glass slides using ImageJ software and reported in square millimetres. Specimen depth will be assessed according to the presence of thoracic wall fatty tissue. Specimen interpretability will be classified as easily interpretable, interpretable with some difficulty, interpretable with great difficulty, or non-interpretable.
Time frame: Up to 4 weeks after thoracoscopy.
Procedure Duration
Procedure duration will be measured in minutes from skin incision to completion of chest tube placement and wound closure.
Time frame: The day of thoracoscopy.
Operator-assessed Device Performance
Operator-assessed device performance will include image quality, ease of manoeuvring, ease of obtaining a biopsy sample, and the operator's expectation that the biopsy sample will provide a definitive histological diagnosis. Each domain will be assessed immediately after the procedure using a visual analogue scale ranging from 0 to 100, with higher scores indicating better operator-assessed performance.
Time frame: Immediately after the thoracoscopic procedure
Post-thoracoscopy Pain Score
Patient-reported post-thoracoscopy pain will be assessed using a 100-mm visual analogue scale while at rest and while coughing. Scores range from 0 to 100, with higher scores indicating more severe pain.
Time frame: At 2, 6, 12, 24, and 48 hours after thoracoscopy
Procedure-related Complications
Procedure-related complications will be classified as major or minor complications. Major complications include empyema, major haemorrhage defined as a drop in haemoglobin of at least 1 g/dL or requiring blood transfusion, persistent air leak for more than 3 days, and re-expansion pulmonary oedema. Minor complications include subcutaneous emphysema, operative site infection, non-infective fever, and minor haemorrhage.
Time frame: At discharge from the index hospitalization, up to 30 days after thoracoscopy.
Postprocedural Length of Hospital Stay
Postprocedural length of hospital stay is defined as the number of days from the date of thoracoscopy to hospital discharge.
Time frame: At discharge from the index hospitalization, up to 30 days after thoracoscopy.
Direct Medical Costs During the Index Hospitalization
Direct medical costs during the index hospitalization will be extracted from hospital billing records. These costs include procedure-related costs, anaesthetic and analgesic medication costs, chest tube and drainage-related costs, postprocedural imaging and management costs, and postprocedural hospitalization costs. Costs will be reported in Chinese Yuan.
Time frame: At discharge from the index hospitalization, up to 30 days after thoracoscopy.
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data that underlie the results reported in the main publication will be made available upon reasonable request. The shared data will include baseline characteristics, allocated intervention, primary and secondary outcome data, and procedure-related complication data.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months after publication of the main trial results and ending 5 years after publication.
Access criteria: Researchers who submit a methodologically sound proposal. Access will be subject to approval by the study investigators and execution of a formal data-sharing agreement.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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