First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.
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: Local Anesthesia Thoracoscopy, Pleuroscopy with Rigid Thoracoscope and Forceps biopsies.
- Who it may be relevant to
- Registry conditions: Suspected Malignant Lung Neoplasm, Pleural Effusion, Pleural Effusion, Malignant, Mesothelioma, Malignant. Basic parameters: 18 years — 90 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
- Greece
- 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
Local Anesthesia Thoracoscopy as a First Line Approach in the Diagnosis of Suspected Malignant Pleural Effusion: FLAT Trial.
Overview
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.
Detailed description
Diagnostic approach of patients with with unexplained lymphocytic exudate is the main subject of the study. Minimally invasive techniques (single entry thoracoscopy with local anesthesia -LAT) have been developed for the definitive biopsy of the parietal pleura, with which, in addition to the diagnosis, a therapeutic pleurodesis can be performed at the same time. Usually, diagnostic LAT is performed only after 3 negative pleural fluid cytological tests have been performed, thus delaying the diagnostic access and treatment of the patient.
The aim of this study is to evaluate the conventional diagnostic approach used in daily clinical practice (3 consecutive punctures of pleural effusion with cytological examination and in case of insufficient diagnosis pleural biopsy, either LAT or VATS depending on the clinical assessment of the patient) with the simplest immediate performance of LAT as soon as a pleural effusion suspected of malignancy is detected. Thus two subject groups will be compared. The first (LAT Group) will undergo Local Anesthesia Thoracoscopy as the first line option for the diagnosis of the suspected MPE. The control group will undergo the standard of care recommended guidelines for the diagnosis of MPE.
Interventions
- Procedure Local Anesthesia Thoracoscopy
The patient is placed in a lateral decubitus, with the affected hemithorax upwards. Ensuring a venous line and full monitoring of vital functions. Mild sedation is given and a dose of Ceftriaxone is given 30 minutes before. Local anesthesia is injected in layers, starting from the skin and working up to the intercostal muscles, intercostal nerve, and periosteum of the rib. Development of pneumothorax is done using a 16-gauge Boutin needle. 15 spontaneous breaths are sufficient to create a pneum - Device Pleuroscopy with Rigid Thoracoscope and Forceps biopsies
A video thoracoscope with an external light source, outer diameter 10 mm (Karl Storz), is inserted into the pleural cavity through a uniportal incision (1 - 1.5 cm) and complete inspection of the pleural cavity is performed. Parietal pleural biopsies are taken with a rigid 40 mm forceps (Karl Storz).
Primary outcome measures
- Time to Diagnosis [Time frame: From enrollment to final diagnosis of MDT, assesed up to 12 months]
- Hospitalization time [Time frame: From enrollment to hospital discharge, assesed up to 3 months]
Secondary outcome measures (3)
- Patient's discomfort/pain [Time frame: Day 1: immediately post-procedure. Day 2: 24hours post-procedure. Day 3 up to Day of tube removal: Every 24 hours. Time frame ends on removal of chest tube or patient dishcarge, assesment up to 2 weeks]
- Complications [Time frame: Day 1: immediately post-procedure. Day 2: 24hours post-procedure. Day 3 up to Day of tube removal: Every 24 hours. Time frame ends on removal of chest tube or patient dishcarge, assesment up to 3 months.]
- Rate of Non Specific Pleuritis [Time frame: Assesment up to 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Greece · 1 center
- Sotiria General Hospital of Thoracic Diseases — Athens
Publications
- Ferguson 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 PMID 37996118
- Wan 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
- Shaikh 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
- Gong 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
- Murthy 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
- Xu 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
- Li 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. PMID 36292425
- Arnold DT, De Fonseka D, Perry S, Morley A, Harvey JE, Medford A, Brett M, Maskell NA. Investigating unilateral pleural effusions: the role of cytology. Eur Respir J. 2018 Nov 8;52(5):1801254. doi: 10.1183/13993003.01254-2018. Print 2018 Nov. PMID 30262573
Identifiers
NCT: NCT06946498 · FLAT1STIPNKUA