Dual-function Semirigid Thoracoscopy Versus Semirigid Thoracoscopy for the Diagnosis of Pleural Diseases: A Multicenter Open-label Randomized Controlled Trial
NCT ID: NCT06744725
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
334 participants
INTERVENTIONAL
2025-01-01
2026-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Dual-function semirigid thoracoscopy
Patients received pleural biopsy using dual-function semirigid thoracoscopy.
Pleural biopsy using dual-function semirigid thoracoscopy
Patients will receive pleural biopsy using dual-function semirigid thoracoscopy.
Semirigid thoracoscopy
Patients received pleural biopsy using semirigid thoracoscopy
Pleural biopsy using semirigid thoracoscopy
Patients received pleural biopsy using semirigid thoracoscopy
Interventions
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Pleural biopsy using dual-function semirigid thoracoscopy
Patients will receive pleural biopsy using dual-function semirigid thoracoscopy.
Pleural biopsy using semirigid thoracoscopy
Patients received pleural biopsy using semirigid thoracoscopy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Gang Hou
Professor
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Mingming Deng, MD,PhD
Role: primary
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2024-UE-1
Identifier Type: -
Identifier Source: org_study_id