Clinical trial · Interventional
First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.
Local Anesthesia Thoracoscopy as a First Line Approach in the Diagnosis of Suspected Malignant Pleural Effusion: FLAT Trial.
NCT06946498CI-TRIAL-00088958FLATrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Non randomized study with two groups. The study group includes patients with suspected malignant pleural effusion, in whom the investigation of pleural effusion begins directly with pleural biopsy by Local Anesthesia Thoracoscopy (LAT). The Control Group includes patients who come to the same hospital and are treated with the Standard of Care (SOC) strategies were used. Efficacy of LAT, Sensitivity, Hospitalization, time to diagnosis and general safety and comfort of the groups' subjects will be assessed.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma, Malignant | Malignant Mesothelioma | ALIAS | 0.90 |
| Pleural Effusion | — | UNRESOLVED | — |
| Pleural Effusion, Malignant | — | UNRESOLVED | — |
| Suspected Malignant Lung Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local Anesthesia Thoracoscopy | Procedure | — | UNRESOLVED |
| Pleuroscopy with Rigid Thoracoscope and Forceps biopsies | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LAT Group
- description
- The study group includes patients in whom the investigation of pleural effusion begins directly with pleural biopsy by Local Anesthesia Thoracoscopy (LAT) under conscious sedation. In these patients, imaging with chest CT and/or thoracic ultrasound has been performed and lymphocytic exudate is confirmed in fluid aspiration.
- interventionNames
- Procedure: Local Anesthesia Thoracoscopy
- Device: Pleuroscopy with Rigid Thoracoscope and Forceps biopsies
- type
- NO_INTERVENTION
- label
- Control Group
- description
- The Control Group includes patients admitted with undiagnosed pleural lymphocytic exudate, who undergo Standard of Care (SOC) diagnostic strategies according to BTS guideline including among others, 3 samples for cytological examination (40-60 ml each), chest tube drainage, microbiological and immunological studies. If the diagnosis is not established and there is still indication for pleural biopsy patients are referred either for surgical biopsy or LAT.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Undiagnosed pleural effusion with the character of a lymphocytic exudate Exclusion Criteria: * Empyema * Transudate pleural effusion. * Central airway obstruction by tumor. * Existence of extensive adhesions that do not allow the development of iatrogenic pneumothorax and the safe entry of the thoracoscope. * Uncontrollable cough. * Acute respiratory failure and/or Hypercapnia. * Performance Status: 5
References
Publications (12)
- BACKGROUNDFerguson J, Tsim S, Kelly C, Alexander L, Shad S, Neilly M, Tate M, Zahra B, Saleh M, Cowell G, Banks E, Grundy S, Corcoran J, Downer N, Stanton A, Evison M, Rahman NM, Maskell N, Blyth KG. Staging by Thoracoscopy in potentially radically treatable Lung Cancer associated with Minimal Pleural Effusion (STRATIFY): protocol of a prospective, multicentre, observational study. BMJ Open Respir Res. 2023 Nov 23;10(1):e001771. doi: 10.1136/bmjresp-2023-001771. PMID 37996118
- BACKGROUNDWan YY, Zhai CC, Lin XS, Yao ZH, Liu QH, Zhu L, Li DZ, Li XL, Wang N, Lin DJ. Safety and complications of medical thoracoscopy in the management of pleural diseases. BMC Pulm Med. 2019 Jul 10;19(1):125. doi: 10.1186/s12890-019-0888-5. PMID 31291926
- BACKGROUNDShaikh F, Lentz RJ, Feller-Kopman D, Maldonado F. Medical thoracoscopy in the diagnosis of pleural disease: a guide for the clinician. Expert Rev Respir Med. 2020 Oct;14(10):987-1000. doi: 10.1080/17476348.2020.1788940. Epub 2020 Jul 12. PMID 32588676
- BACKGROUNDGong L, Huang G, Huang Y, Liu D, Tang X. Medical Thoracoscopy for the Management of Exudative Pleural Effusion: A Retrospective Study. Risk Manag Healthc Policy. 2020 Dec 4;13:2845-2855. doi: 10.2147/RMHP.S287758. eCollection 2020. PMID 33324122
- BACKGROUNDMurthy V, Bessich JL. Medical thoracoscopy and its evolving role in the diagnosis and treatment of pleural disease. J Thorac Dis. 2017 Sep;9(Suppl 10):S1011-S1021. doi: 10.21037/jtd.2017.06.37. PMID 29214061
- BACKGROUNDXu LL, Yang Y, Wang Z, Wang XJ, Tong ZH, Shi HZ. Malignant pleural mesothelioma: diagnostic value of medical thoracoscopy and long-term prognostic analysis. BMC Pulm Med. 2018 Apr 3;18(1):56. doi: 10.1186/s12890-018-0619-3. PMID 29615010
- BACKGROUNDLi D, Jackson K, Panchal R, Aujayeb A. Local Anaesthetic Thoracoscopy for Pleural Effusion-A Narrative Review. Healthcare (Basel). 2022 Oct 9;10(10):1978. doi: 10.3390/healthcare10101978.