Suspected Malignant Lung NeoplasmFLATNCT06946498
First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.
A study testing Local Anesthesia Thoracoscopy and Pleuroscopy with Rigid Thoracoscope and Forceps biopsies in people with Suspected Malignant Lung Neoplasm and Pleural Effusion, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Suspected Malignant Lung Neoplasm, Pleural Effusion, Pleural Effusion, Malignant
- What is being tested?
- Local Anesthesia Thoracoscopy and Pleuroscopy with Rigid Thoracoscope and Forceps biopsies
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 23 May 2023to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undiagnosed pleural effusion with the character of a lymphocytic exudate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Sotiria General Hospital of Thoracic Diseases
Athens, Attica, 11527
Nektratios Anagnostopoulos, Ass. Professor, +306946869480, aris.anag@yahoo.gr
Michail Kon/nos Tsatsis, MD, MSc, PhD(c)
About this study
Official title: Local Anesthesia Thoracoscopy as a First Line Approach in the Diagnosis of Suspected Malignant Pleural Effusion: FLAT Trial.
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.
Read the 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.
- Conditions
- Suspected Malignant Lung Neoplasm, Pleural Effusion, Pleural Effusion, Malignant, Mesothelioma, Malignant
- Being tested
- Local Anesthesia Thoracoscopy, Pleuroscopy with Rigid Thoracoscope and Forceps biopsies
- Keywords
- Malignant Pleural Effusion, Local Anesthesia Thoracoscopy, Medical Thoracoscopy, Lung cancer, Mesothelioma, Lymphocytic Exudate
- Medical subject headings
- Pleural Effusion, Pleural Effusion, Malignant, Mesothelioma, Malignant, Lung Neoplasms, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Anesthesia ThoracoscopyProcedure or surgery
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 pneumothorax, and entry of rigid thoracoscope into the hemithorax through a 11-13 mm Trocar. Multiple biopsies from the parietal pleura are taken and pleurodesis is made according to operator judgment. A chest drain 20-22 G is placed and sutured.
A chest X-ray is performed 2-8 hours later after the patient is transferred to the ward. Chest drain is removed after 24h if fluid production is <250ml and lung re-expansion.
Pleuroscopy with Rigid Thoracoscope and Forceps biopsiesDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| LAT Group | Experimental | 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. Receives: Procedure: Local Anesthesia Thoracoscopy; Device: Pleuroscopy with Rigid Thoracoscope and Forceps biopsies |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Diagnosis
Time to diagnosis is defined as the period between the first thoracentesis ,showing a lymphocytic exudate, of a newly discovered pleural effusion in a patient without prior signs of pleural disease to the time of multi-disciplinary team final diagnosis involving a pathology report of biopsy samples.
Measured: From enrollment to final diagnosis of MDT, assesed up to 12 months
Hospitalization time
The time from the patient's admission in the hospital with diagnosis of unexplained lymphocytic pleural effusion until discharge with or without final diagnosis.
Measured: From enrollment to hospital discharge, assesed up to 3 months
Secondary outcomes (3)
Patient's discomfort/pain
A Visual Analogue Scale (VAS) measures the intensity of pain the patient feels after the intervention (Medical Thoracoscopy vs Surgical Biopsy). A horizontal line ranging from 0 to 10, (0=No pain, 10=Extreme pain), is used. The patient is examined every day, until his discharge and is asked to mark on the line his respective level of discomfort/pain.
Measured: 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
We compare the rate of post interventional complications across the two groups (Surgical biopsy vs LAT)
Measured: 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
We aim to asses wheter the rate of positive pleural biopsies for non specific pleuritis differed significantly between Surgical biopsy group and LAT group.
Measured: Assesment up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start23 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Suspected Malignant Lung NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Sotiria Thoracic Diseases Hospital of Athens
- Responsible party
- Principal investigator, Stratakos Grigorios, National and Kapodistrian University of Athens
- Investigators
- Grigorios Stratakos, Professor, Study director, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946498
- Sponsor's protocol ID
- FLAT1STIPNKUA
- Acronym
- FLAT
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a preliminary study design and for confidentiality rationales in order to protect the novelty of diagnostic strategies implemented in this research .
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 Nov 23;10(1):e001771. doi: 10.1136/bmjresp-2023-001771.
PubMed 37996118Wan 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.
PubMed 31291926Shaikh 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.
PubMed 32588676Gong 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.
PubMed 33324122Murthy 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.
PubMed 29214061Xu 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.
PubMed 29615010Li 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.
PubMed 36292425Arnold 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.
PubMed 30262573Kiani A, Abedini A, Karimi M, Samadi K, Sheikhy K, Farzanegan B, Pour Abdollah M, Jamaati H, Jabardarjani HR, Masjedi MR. Diagnostic Yield of Medical Thoracoscopy in Undiagnosed Pleural Effusion. Tanaffos. 2015;14(4):227-31.
PubMed 27114723Wu YB, Xu LL, Wang XJ, Wang Z, Zhang J, Tong ZH, Shi HZ. Diagnostic value of medical thoracoscopy in malignant pleural effusion. BMC Pulm Med. 2017 Aug 4;17(1):109. doi: 10.1186/s12890-017-0451-1.
PubMed 28778184Kassirian S, Hinton SN, Cuninghame S, Chaudhary R, Iansavitchene A, Amjadi K, Dhaliwal I, Zeman-Pocrnich C, Mitchell MA. Diagnostic sensitivity of pleural fluid cytology in malignant pleural effusions: systematic review and meta-analysis. Thorax. 2023 Jan;78(1):32-40. doi: 10.1136/thoraxjnl-2021-217959. Epub 2022 Feb 2.
PubMed 35110369Tsim S, Paterson S, Cartwright D, Fong CJ, Alexander L, Kelly C, Holme J, Evison M, Blyth KG. Baseline predictors of negative and incomplete pleural cytology in patients with suspected pleural malignancy - Data supporting 'Direct to LAT' in selected groups. Lung Cancer. 2019 Jul;133:123-129. doi: 10.1016/j.lungcan.2019.05.017. Epub 2019 May 16.
PubMed 31200818