Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Multicenter Open-label Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pleural biopsy using dual-function semirigid thoracoscopy, Pleural biopsy using semirigid thoracoscopy.
- Who it may be relevant to
- Registry conditions: Pleural Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Protocol for a Multicenter Open-label Randomized Controlled Trial
Overview
We designed and developed a novel dual-function semirigid thoracoscope (UE FET-680; UE Corporation, Zhejiang, China) with a straight channel adapted to flexible and rigid forceps for pleural biopsy. Our preclinical trial has proven that the dual-function semirigid thoracoscope has larger and deeper sampling while retaining the entire thoracic accessibility and flexible bronchoscopic maneuvering habits of the semirigid thoracoscope. We designed this study to directly compare the diagnostic yield, quality of sampling, and safety between the dual-function semirigid thoracoscope and semirigid thoracoscope.
Interventions
- Device Pleural biopsy using dual-function semirigid thoracoscopy
Patients will receive pleural biopsy using dual-function semirigid thoracoscopy. - Device Pleural biopsy using semirigid thoracoscopy
Patients received pleural biopsy using semirigid thoracoscopy
Primary outcome measures
- Diagnostic yield [Time frame: 6 Month]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Unilateral pleural effusion of unclear etiology after a less invasive diagnosis
- Fully informed of the purpose and method of the study, agreed to participate in the study, and signed an informed consent form.
Exclusion criteria
- PaO2/FiO2 < 300
- Tendency for uncontrolled bleeding, unstable cardiovascular status, or severe heart failure
- A complete pleural symphysis, where it is not possible to create a pneumothorax
- Refractory cough
- Eastern Cooperative Oncology Group performance status 4
- Disagreements regarding study participation
- Participation in other studies within three months without withdrawal or termination.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Publications
- Lee P, Colt HG. Rigid and semirigid pleuroscopy: the future is bright. Respirology. 2005 Sep;10(4):418-25. doi: 10.1111/j.1440-1843.2005.00737.x. PMID 16135163
- 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. PMID 23418922
- Agarwal R, Aggarwal AN, Gupta D. Diagnostic accuracy and safety of semirigid thoracoscopy in exudative pleural effusions: a meta-analysis. Chest. 2013 Dec;144(6):1857-1867. doi: 10.1378/chest.13-1187. PMID 23928984
- Collins 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. PMID 3581930
- Venekamp LN, Velkeniers B, Noppen M. Does 'idiopathic pleuritis' exist? Natural history of non-specific pleuritis diagnosed after thoracoscopy. Respiration. 2005 Jan-Feb;72(1):74-8. doi: 10.1159/000083404. PMID 15753638
- Bhatnagar R, Maskell N. The modern diagnosis and management of pleural effusions. BMJ. 2015 Sep 8;351:h4520. doi: 10.1136/bmj.h4520. No abstract available. PMID 26350935
- Deng M, Liu X, Chen W, Wei S, Zheng Z, Liao L, Zhang Q, Li J, Tong R, Porcel JM, Wang T, Hou G. Dual-functIon Semi-rigid thoraCoscOpy Versus semi-rigid thoracoscopy for the diagnosis of plEuRal diseases: protocol for a multicentre, open-label, randomised controlled trial in China (DISCOVER-I). Respir Res. 2026 Feb 9;27(1):129. doi: 10.1186/s12931-026-03554-0. PMID 41656194
Identifiers
NCT: NCT06744725 · 2024-UE-1