[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588829":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":66,"collaborators":69,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":19,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":48,"whyStopped":19,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"National and Kapodistrian University of Athens","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002For thoracic ultrasound has been performed and lymphocytic exudate is confirmed in fluid aspiration.",[13,14],"Procedure: Local Anesthesia Thoracoscopy","Device: Pleuroscopy with Rigid Thoracoscope and Forceps biopsies",{"label":16,"type":17,"description":18,"interventionNames":19},"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.",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"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.\n\nDevelopment 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.\n\nA 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 \\\u003C250ml and lung re-expansion.",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":19},"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).",[9],[32],{"name":33,"affiliation":5,"role":34},"Grigorios Stratakos, Professor","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"Nektarios ANAGNOSTOPOULOS, Ass. professor","CONTACT","+306946869480","aris.anag@yahoo.gr",{"name":42,"role":38,"phone":43,"phoneExt":19,"email":44},"Michail Kon\u002Fnos Tsatsis, MD, MSc, PhDc","+306979234105","tsatsis.mihail@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Sotiria General Hospital of Thoracic Diseases","RECRUITING","Athens","Attica","11527","Greece","GR",{"type":55,"coordinates":56},"Point",[57,58],23.72784,37.98376,{"lat":58,"lon":57},[61,63],{"name":62,"role":38,"phone":39,"phoneExt":19,"email":40},"Nektratios Anagnostopoulos, Ass. Professor",{"name":64,"role":65,"phone":19,"phoneExt":19,"email":19},"Michail Kon\u002Fnos Tsatsis, MD, MSc, PhD(c)","PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Stratakos Grigorios","Professor of Interventional Pulmonology",[70],{"name":71,"class":6},"Sotiria Thoracic Diseases Hospital of Athens","100588829","first-local-anaesthesia-thoracoscopy-for-pleural-effusion-diagnosis-100588829",false,"NCT06946498","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.","FLAT","Inclusion Criteria:\n\n* Undiagnosed pleural effusion with the character of a lymphocytic exudate\n\nExclusion Criteria:\n\n* Empyema\n* Transudate pleural effusion.\n* Central airway obstruction by tumor.\n* Existence of extensive adhesions that do not allow the development of iatrogenic pneumothorax and the safe entry of the thoracoscope.\n* Uncontrollable cough.\n* Acute respiratory failure and\u002For Hypercapnia.\n* Performance Status: 5","ALL","18 Years","90 Years",{"count":84,"type":85},100,"ESTIMATED","INTERVENTIONAL",[88],"NA","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).\n\nThe 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.",[91,92,93,94],"Suspected Malignant Lung Neoplasm","Pleural Effusion","Pleural Effusion, Malignant","Mesothelioma, Malignant",[96,23,97,98,99,100],"Malignant Pleural Effusion","Medical Thoracoscopy","Lung cancer","Mesothelioma","Lymphocytic Exudate","2025-04-20",{"date":103,"type":104},"2025-04-27","ACTUAL",{"date":106,"type":104},"2023-05-23",{"date":108,"type":85},"2026-12-31",{"name":5,"class":6},1]