[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mediastinal-lymphadenopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mediastinal-lymphadenopathy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,81,104,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100644397","feasibility-and-preliminary-performance-of-an-ai-prototype-for-digital-rose-during-ebus-tbna-and-peripheral-tbna-a-prospective-pilot-study-ai-rose-feas-100644397",false,"NCT07662967","Feasibility and Preliminary Performance of an AI Prototype for Digital ROSE During EBUS-TBNA and Peripheral TBNA: a Prospective Pilot Study (AI-ROSE-FEAS)","Preliminary Feasibility and Diagnostic Performance of an Investigational Artificial Intelligence Prototype for Digital Rapid On-Site Evaluation (ROSE) of Cytological Slides During Diagnostic Bronchoscopy With Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) and Peripheral Transbronchial Needle Aspiration: a Prospective Monocentric Pilot Study (AI-ROSE-FEAS)","AI-ROSE-FEAS","Inclusion Criteria\n\n* Age ≥ 18 years.\n* Clinical indication for diagnostic bronchoscopy with EBUS-TBNA for mediastinal lymphadenopathy and\u002For TBNA on peripheral lung lesions, according to ACCP\u002FERS-ESTS guidelines and the Unit's diagnostic pathways.\n* The procedure will be performed in two-person mode with IP-ROSE performed as per the center's SOP.\n* Ability to provide written informed consent.\n* Willingness to undergo the required follow-up.\n\nExclusion Criteria\n\n* Absolute contraindications to bronchoscopy.\n* Known histological diagnosis of the target lesion (except re-staging).\n* Concomitant interventional procedures that alter the standard sequence.\n* Inability to provide written informed consent.\n* Any condition that, in the investigator's judgment, compromises patient safety or the reliability of the data.","ALL","18 Years",{"count":20,"type":21},65,"ESTIMATED","6 Months","OBSERVATIONAL","Rapid On-Site Evaluation (ROSE) of cytological slides obtained during EBUS-TBNA improves diagnostic yield by providing real-time adequacy assessment and preliminary diagnostic orientation after each needle pass. In centers without a dedicated cytopathologist, ROSE is performed by a second interventional pulmonologist acting as a dedicated ROSE operator (interventional pulmonologist-performed ROSE, IP-ROSE), a model associated with good but variable diagnostic performance compared to cytopathologist-performed ROSE.\n\nThis study evaluates the feasibility and preliminary diagnostic performance of an investigational artificial intelligence prototype for digital ROSE. The prototype, developed in-house by the Principal Investigator, analyzes microscopic images of Diff-Quik stained cytological slides acquired through a dedicated digital microscope, together with basic clinical data, via API calls to a multimodal AI model. It produces two outputs: sample adequacy (appropriate\u002Fnot appropriate) and malignancy suspicion (benign\u002Fmalignant), each with a confidence score. The AI output is recorded in the study database for research purposes only and is not shown to the operator in real time; it does not influence clinical decisions during the procedure.\n\nThe study is a prospective, monocentric, observational pilot study enrolling 65 adult patients undergoing EBUS-TBNA or peripheral TBNA with IP-ROSE at a single interventional pulmonology unit. The primary statistical unit is the individual ROSE slide, with an expected 130 to 160 evaluable slides. Co-primary endpoints are: (1) technical feasibility of the AI prototype, defined as the proportion of slides with valid AI output within 90 seconds; and (2) AI accuracy for sample adequacy assessment compared to the definitive cytopathological diagnosis, with an expected 95% confidence interval precision of ±5.5%. Secondary endpoints include AI accuracy for malignancy suspicion, agreement between the AI prototype and the IP-ROSE operator, and AI output latency.\n\nThe AI prototype is not a commercially approved or CE-marked medical device. It was developed internally by the Principal Investigator for research purposes and is evaluated exclusively within this study. Data from this pilot study will inform the design of a subsequent confirmatory non-inferiority trial, which will be the subject of separate registration and ethical approval.",[26,27,28,29,30,31,32],"Lung Neoplasms","Bronchoscopy","AI (Artificial Intelligence)","Mediastinal ( Chest) Masses","Mediastinal Lymphadenopathy","EBUS Guided Transbronchial Needle Aspiration","Lung Cancer (Diagnosis)",[34,35],"bronchoscopy","artificial intelligence","NOT_YET_RECRUITING","2026-06-17",{"date":39,"type":40},"2026-06-23","ACTUAL",{"date":42,"type":21},"2026-07-01",{"date":44,"type":21},"2027-03",{"name":46,"class":47},"Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100625605","comparison-of-two-needle-agitation-strategies-in-endobronchial-ultrasound-guided-transbronchial-needle-aspiration-ebus-tbna-for-diagnostic-yield-100625605","NCT07424807","Comparison of Two Needle Agitation Strategies in Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) for Diagnostic Yield","A Randomized, Single-Blind Controlled Trial Comparing Two Needle Agitation Strategies During Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration for Diagnostic Yield in Patients With Enlarged Mediastinal Lymph Nodes","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Presence of enlarged mediastinal or hilar lymph nodes requiring diagnostic evaluation on chest computed tomography (CT), defined as short-axis diameter ≥ 10 mm measured on axial images\n* Clinical indication for EBUS-TBNA\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Uncorrected coagulation disorders (platelet count \\\u003C 100,000\u002Fmm³; International normalized ratio (INR) \\> 1.5; or prothrombin time \\\u003C 50% of control)\n* Acute myocardial infarction within the preceding 4 weeks or ongoing unstable angina\n* Significant upper airway obstruction (benign or malignant) with ≥ 50% reduction in tracheal lumen diameter\n* Hemodynamic instability (e.g., persistent hypotension, significant arrhythmia, or need for vasopressors)\n* Respiratory failure refractory to oxygen therapy, defined as sustained Peripheral oxygen saturation (SpO₂) ≤ 90% despite supplemental oxygen\n* Intractable cough precluding bronchoscopy\n* History of severe allergy to local anesthetics or sedative agents used during the procedure\n* Refusal or inability to provide informed consent",{"count":56,"type":21},180,"INTERVENTIONAL",[59],"NA","The goal of this clinical trial is to learn whether the number of needle agitations during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) affects diagnostic yield in patients with enlarged mediastinal lymph nodes. The study will also evaluate tissue sample quality and the safety of different needle agitation strategies.\n\nThe main questions it aims to answer are:\n\nDoes the number of needle agitations improve diagnostic yield? Does a higher number of needle agitations increase tissue core length and specimen adequacy? Are there differences in procedure-related complications between the two needle agitation strategies? Researchers will compare two needle agitation strategies during EBUS-TBNA to see if one approach provides better diagnostic performance, improved sample quality, and similar procedural safety.\n\nParticipants will:\n\n* Undergo EBUS-TBNA as part of their clinical evaluation\n* Be randomly assigned to one of two needle agitation strategies\n* Have tissue samples measured for core length and assessed for diagnostic adequacy\n* Be monitored for procedure-related complications",[30],[63,64,65,66,67,68,69],"EBUS-TBNA","Needle Agitation","Tissue Core Length","Specimen Adequacy","Mediastinal Lymph Nodes","Randomized Controlled Trial","diagnostic yield","RECRUITING","2026-04-27",{"date":73,"type":40},"2026-05-01",{"date":75,"type":40},"2026-02-16",{"date":77,"type":21},"2028-12",{"name":79,"class":47},"Phan Quang Hieu",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":57,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":80},"100616137","safety-and-performance-profile-of-cryobiopsy-in-bronchial-endoscopy-100616137","NCT07301697","Safety and Performance Profile of Cryobiopsy in Bronchial Endoscopy","SeReCryo","Inclusion Criteria:\n\n* All patients who have undergone, or are eligible for, a cryobiopsy according to national or international recommendations, or after failure of a first diagnostic test followed by a collegial discussion regarding the indication for cryobiopsy.\n* Procedure performed within the bronchial endoscopy department of the New Civil Hospital of the University Hospitals of Strasbourg.\n* For diffuse interstitial lung diseases: decision to perform a transbronchial cryobiopsy after case review in a multidisciplinary consultation meeting for patients whose specific type of ILD could not be determined with thoracic imaging and biological tests alone, for patients not eligible for surgical lung biopsy (SLB) due to the severity of their respiratory condition, or as an alternative to SLB (according to the recommendations of the European Respiratory Society).\n* For lymph node puncture (EBUS-cryobiopsy): after discussing the case in a multidisciplinary concentration meeting, in patients with a lesion and\u002For mediastinal adenopathy, as a second- or third-line procedure, following the diagnostic failure of bronchial fibroscopy and\u002For transbronchial needle aspiration guided by endobronchial ultrasound (EBUS-TBNA). For patients with a strong suspicion of lymphoma, EBUS-cryobiopsy can be performed as a first-line procedure in parallel with EBUS-TBNA (which is systematically performed during the same procedure) in order to reduce the diagnostic delay.\n* For the retrospective analysis: all patients who underwent a cryobiopsy, and those who had a CT-guided lung biopsy for diagnostic assessment of an ILD or evaluation of suspected pulmonary neoplasm, since July 2024.\n\nExclusion Criteria:\n\n* \\- Patients under 18 years of age.\n* Pregnant or breastfeeding women.\n* Patients under guardianship, curatorship, or legal protection.\n* Patients at increased risk of bleeding: patients on anticoagulants not stopped for 24 hours, or on direct oral anticoagulants not stopped for 5 days, or with INR \\> 1.5 for patients on VKAs and heparin. Patients on dual antiplatelet therapy. Platelet count below 50 G\u002FL.\n* Saturation below 90% on oxygen therapy with a maximum allowable flow of 2 L\u002Fmin.\n* Pre-existing severe heart disease: unstable angina, myocardial infarction, decompensated heart failure.\n* Known pulmonary hypertension with systolic pulmonary arterial pressure above 50 mmHg on transthoracic echocardiography.\n* Inability to provide the subject with informed information (emergency situation, subject has difficulty understanding, etc.)",{"count":89,"type":21},30,[59],"Transbronchial cryobiopsy is a relatively recent technique, increasingly used for the diagnosis of various respiratory diseases, including neoplasms, diffuse interstitial lung diseases (ILDs), and rejection after lung transplantation. Currently, its use is included in European recommendations for the diagnosis of interstitial lung diseases. EBUS-cryobiopsy, on the other hand, has proven useful in the evaluation of lesions and mediastinal lymphadenopathy. Several studies have compared this method to the reference technique, EBUS-TBNA (endobronchial ultrasound-guided transbronchial needle aspiration), and the results suggest a higher diagnostic yield for cryobiopsy, particularly for detecting benign lesions and lymphomas. However, to date, no French recommendation has yet been published regarding the precise role of this examination in the management of mediastinal lesions. Since July 2024, transbronchial cryobiopsies and EBUS-cryobiopsies have been routinely performed in the thoracic endoscopy department of Strasbourg University Hospital by an experienced team of interventional pulmonologists. The indications are those described above, after approval in a multidisciplinary consultation meeting. The number of prospective studies on cryobiopsies is currently limited. With this study, the investigators aim to carry out work intended to complement the current data on the profitability and safety of using cryobiopsies in the center, based on their results obtained since July 2024, as well as through prospective data collection from procedures performed over a one-year period. In addition to a prospective component, this study has the strong point of evaluating the procedure conducted by a limited number of experienced operators, thereby reducing the risk of significant inter-operator variability, as has been observed in previous studies. Finally, this is the first French study on the subject. The investigators hypothesize that performing cryobiopsies in a large university hospital by experienced operators allows for obtaining satisfactory diagnostic results under good safety conditions.",[30,93,94],"Mediastinal Lesions","Diffuse Interstitial Lung Diseases","2026-01-13",{"date":97,"type":40},"2026-01-15",{"date":99,"type":40},"2026-01-09",{"date":101,"type":21},"2027-04-19",{"name":103,"class":47},"University Hospital, Strasbourg, France",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100542828","mediastinal-ebus-cryobiopsy-study-in-sweden-100542828","NCT06347939","Mediastinal EBUS Cryobiopsy Study In Sweden","Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden","MECRIS","Inclusion Criteria:\n\n* Mediastinal lymphadenopathy with a diameter greater than 1 cm.\n* Indication for assessment and sampling according to clinical praxis\n* Age \\> 18 years\n* Patients consent to participate in the study.\n\nExclusion Criteria:\n\n* Hemodynamically instable patient\n* Myocardial infarction in the last six weeks prior to participating in the study.\n* Life threatening arrythmia\n* Respiratory failure and inadequate blood oxygenation despite oxygen supply.\n* Tracheal obstruction of high grade.\n* High bleeding risk\n* Patient not willing to participate in the study\n* Patient not speaking swedish and needing translator during the procedure",{"count":113,"type":21},200,"This study is a prospective observational non-randomized clinical trial where all the participitants undergo the same procedure and every participitant's samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB on all the study participants.The cryobiopsy samples are numbered to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same participitant. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis).\n\nFollow up four weeks after the procedure to assess the risk for postoperative complications.",[30,116,117,118,119],"Lung Cancer","Sarcoidosis","Lymphoma","Tuberculosis",[121,122,117,119,118],"Mediastinal lymphadenopathy","Lung cancer","2025-07-14",{"date":125,"type":40},"2025-07-17",{"date":127,"type":40},"2024-04-01",{"date":129,"type":21},"2028-12-31",{"name":131,"class":47},"Region Skane",2,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":57,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":80},"100573098","confocal-laser-endomicroscopy-assisted-endobronchial-ultrasound-guided--transbronchial-mediastinal-cryobiopsy-via-a-tunnel-for-diagnosing-mediastinal-lymphadenopathy-100573098","NCT06741852","Confocal Laser Endomicroscopy Assisted Endobronchial Ultrasound-guided- Transbronchial Mediastinal Cryobiopsy Via a Tunnel for Diagnosing Mediastinal Lymphadenopathy","The Diagnostic Yield and Safety of Confocal Laser Endomicroscopy Assisted Endobronchial Ultrasound-guided Mediastinal Cryobiopsy Via a Tunnel for Diagnosing Mediastinal Lymphadenopathy: a Multi-center Randomized Controlled Trial.","Inclusion Criteria:\n\n* (1) Age ≥18 years old; (2) Patients with at least one mediastinal and\u002For hilar lymphadenopathy (short-axis ≥1cm that is detected by chest CT or contrast CT; (3) Patients with recently discovered mediastinal lesions, clinical respiratory symptoms of cough, expectoration, thoracalgia, or complicated lung lesions implicated by thoracic image, which indicates the need of biopsy to identify the etiology; (4) Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.\n\nExclusion Criteria:\n\n* (1) The lesion is a mediastinal cyst or abscess; (2) Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy; (3) EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy; (4) EBUS did not detect lesions in the hilum and\u002For mediastinum; (5) Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc.",{"count":141,"type":21},98,[59],"Mediastinal and\u002For hilar lymphadenopathy (MHL) becoming more and more common in clinical practice with the development of imaging technique. MHL is secondary to various benign and malignant disorders that could be life-threatening conditions due to compression of airways or blood vessels. Accurate and timely diagnosis is important for managing patients with lymphadenopathy. Nowadays, several invasive mediastinal tissue samplings have been designed and development.\n\nFor patients with metastatic lymphadenopathy, endobronchial ultrasound (EBUS) guided transbronchial needle aspiration has been recommended as a first-line diagnostic method by several guidelines due to its highly diagnostic sensitivity for non-small cell lung cancer and acceptable safety.However, the relatively limited material retrieved by needle aspiration restricts its diagnostic yield in non-metastatic lymphadenopathy including sarcoidosis, lymphoma, tuberculosis, etc.6,7 It is important to obtain the representative sample which showed the specific pathology for diagnosing patients with non-metastatic lymphadenopathy. Therefore, previous studies attempt to use transbronchial mediastinal cryobiopsy (TBMC) to obtain acquiring samples with sufficient volume suitable for histological and molecular analyses.\n\nDespite several studies have proved that TBMC has a highly diagnostic yield, the heterogeneity of pathologic characteristics in lymph node makes obtaining a representative sample difficult. To overcome the sampling heterogeneity and obtain the possibility of obtaining a representative sample in mediastinal lesions, increasing sampling number had been proved as an effective method in previous studies (5-times TBNA, thrice TBMC). With the increasing sampling number, the potential risk related to the procedure is higher than before.\n\nNeedle-based confocal laser endomicroscopy (nCLE) is a laser-based imaging technique that utilizes fluorescence for real-time microscopic imaging at the biopsy needle tip. Compared to EBUS, nCLE enables real-time visualisation of cell shapes, there by acting a real-time microscope. Besides, we had developed a novel procedure which can built a tunnel between airway wall and target lymph node using a puncture dilation catheter and allows various tools to perform procedure, its efficacy and safety had been proved in our published studies.Based on this tunnel, we could perform TBMC under the nCLE guidance. The area with representative pathology of lymph node may be detected by nCLE, and shorten the sampling number. However, it remains unknown which of these techniques is the superior match for needle biopsy.",[30],"2024-12-16",{"date":147,"type":40},"2024-12-19",{"date":149,"type":21},"2025-01-01",{"date":151,"type":21},"2026-12-31",{"name":153,"class":47},"China-Japan Friendship Hospital"]