[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629792":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":52,"studyPopulation":44,"armGroups":53,"interventions":66,"overallOfficials":44,"centralContacts":77,"locations":87,"responsibleParty":162,"collaborators":44,"id":164,"slug":44,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":165,"sex":171,"minAge":172,"maxAge":173,"enrollmentInfo":174,"targetDuration":44,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":185,"overallStatus":90,"whyStopped":44,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"Fondazione del Piemonte per l'Oncologia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Duration of pleural drainage","Time from surgery to chest tube removal, measured in hours.","From surgery to chest tube removal, assessed up to 30 days after surgery",[14,18,22,26,30,34,38,41],{"measure":15,"description":16,"timeFrame":17},"Postoperative hospital length of stay","Time from surgery to hospital discharge, measured in days.","From surgery to hospital discharge, assessed up to 30 days after surgery",{"measure":19,"description":20,"timeFrame":21},"Incidence and volume of postoperative air leaks","Proportion of patients with at least one documented postoperative air leak and mean daily and total postoperative air leak volume, as recorded by the digital drainage system.","Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery",{"measure":23,"description":24,"timeFrame":25},"Incidence of residual pleural space","Proportion of patients with residual pleural space detected on chest imaging during postoperative hospitalization or at follow-up assessment.","During postoperative hospitalization and at follow-up visits at 1 month and 2 months after discharge",{"measure":27,"description":28,"timeFrame":29},"Postoperative safety outcomes","Incidence of postoperative adverse events and complications, including thoracentesis, new chest drainage, hospital readmission, and re-intervention.","During postoperative hospitalization and up to 30 days after surgery",{"measure":31,"description":32,"timeFrame":33},"Duration of postoperative air leak","Time from surgery to resolution of postoperative air leak, measured in hours.","From surgery to resolution of postoperative air leak during postoperative hospitalization, assessed up to 30 days after surgery",{"measure":35,"description":36,"timeFrame":37},"Duration of surgical procedure","Total duration of the surgical procedure, measured in minutes.","During the surgical procedure",{"measure":39,"description":40,"timeFrame":21},"Mean daily and total postoperative air leak volume","Mean daily postoperative air leak volume and cumulative total postoperative air leak volume, measured in liters using the digital drainage system.",{"measure":42,"description":43,"timeFrame":21},"Air leak indices corrected for length of dissected pulmonary parenchyma","Quantitative postoperative air leak measures adjusted for the length of dissected pulmonary parenchyma to standardize comparisons between patients.",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":44,"timePerspective":44,"maskingInfo":50},"RANDOMIZED","PARALLEL","Patients undergoing VATS upper or lower lobectomy for NSCLC are randomized 1:1 intraoperatively to either standard fissure completion with mechanical staplers alone (control group) or mechanical staplers plus Progel Platinum sealant (experimental group). The study is multicenter and will be conducted in 8 thoracic surgery centers.","TREATMENT",{"masking":51,"maskingDescription":44,"whoMasked":44},"NONE","Lobectomy is the standard surgical treatment for many patients with early-stage NSCLC, but postoperative air leak remains a frequent complication associated with prolonged chest tube duration, longer hospitalization, and increased healthcare costs. Preliminary non-randomized evidence suggests that Progel Platinum may improve intraoperative sealing of fissure lines and reduce postoperative air leaks. E-SEAL is a prospective, randomized, controlled, multicenter study in 8 thoracic surgery centers. Eligible adult patients undergoing minimally invasive VATS upper or lower lobectomy for NSCLC are randomized 1:1 to stapling alone or stapling plus Progel Platinum. The primary endpoint is pleural drainage duration in hours. Secondary endpoints include postoperative length of stay, hospitalization costs, postoperative air leak incidence and volume, residual pleural space, complications, re-interventions, and follow-up outcomes up to 60 days after surgery\u002Fdischarge.",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"Progel Group (PG)","EXPERIMENTAL","Fissure completion with mechanical staplers followed by application of Progel Platinum sealant along the fissure completion line.",[59],"Device: Progel Platinum",{"label":61,"type":62,"description":63,"interventionNames":64},"Standard Treatment Group (ST)","ACTIVE_COMPARATOR","Fissure completion with mechanical staplers alone, according to current standard practice.",[65],"Procedure: Mechanical Stapling",[67,72],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":44},"DEVICE","Progel Platinum","Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy",[55],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":44},"PROCEDURE","Mechanical Stapling","Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.",[61],[78,83],{"name":79,"role":80,"phone":81,"phoneExt":44,"email":82},"Andrea Droghetti MD","CONTACT","00390119933850","andrea.droghetti@ircc.it",{"name":84,"role":80,"phone":85,"phoneExt":44,"email":86},"Annamaria Nuzzo PHD","00390119933844","annamaria.nuzzo@ircc.it",[88,106,118,129,140,151],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Unità di Chirurgia Toracica Oncologica","RECRUITING","Candiolo","Torino","10060","Italy","IT",{"type":97,"coordinates":98},"Point",[99,100],7.59812,44.95858,{"lat":100,"lon":99},[103],{"name":104,"role":80,"phone":105,"phoneExt":44,"email":82},"Andrea Droghetti, MD","+390119933850",{"facility":107,"status":108,"city":109,"state":44,"zip":44,"country":94,"countryCode":95,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Ospedale centrale di Bolzano, Chirurgia Toracica e Vascolare","NOT_YET_RECRUITING","Bolzano",{"type":97,"coordinates":111},[112,113],11.33982,46.49067,{"lat":113,"lon":112},[116],{"name":117,"role":80,"phone":44,"phoneExt":44,"email":44},"Francesco Zaraca",{"facility":119,"status":108,"city":120,"state":44,"zip":44,"country":94,"countryCode":95,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Azienda Ospedaliero-Universitaria Careggi","Florence",{"type":97,"coordinates":122},[123,124],11.24626,43.77925,{"lat":124,"lon":123},[127],{"name":128,"role":80,"phone":44,"phoneExt":44,"email":44},"Alessandro Gonfiotti",{"facility":130,"status":108,"city":131,"state":44,"zip":44,"country":94,"countryCode":95,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico","Milan",{"type":97,"coordinates":133},[134,135],12.59836,42.78235,{"lat":135,"lon":134},[138],{"name":139,"role":80,"phone":44,"phoneExt":44,"email":44},"Mario Nosotti",{"facility":141,"status":108,"city":142,"state":44,"zip":44,"country":94,"countryCode":95,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Irccs Ismett","Palermo",{"type":97,"coordinates":144},[145,146],13.3636,38.1166,{"lat":146,"lon":145},[149],{"name":150,"role":80,"phone":44,"phoneExt":44,"email":44},"Alessandro Bertani",{"facility":152,"status":108,"city":153,"state":44,"zip":44,"country":94,"countryCode":95,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Azienda Ospedaliera-Universitaria Pisana","Pisa",{"type":97,"coordinates":155},[156,157],10.4036,43.70853,{"lat":157,"lon":156},[160],{"name":161,"role":80,"phone":44,"phoneExt":44,"email":44},"Marcello Carlo Ambrogi",{"type":163,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100629792",false,"NCT07479277","Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC","A Multicenter, Randomized, Parallel-Group Trial Evaluating Progel Platinum Added to Mechanical Stapling Versus Mechanical Stapling Alone in Patients Undergoing VATS Upper or Lower Lobectomy for Non-Small Cell Lung Cancer","E-SEAL","Inclusion Criteria:\n\n* Age ≥18 years\n* Written informed consent\n* Planned VATS upper or lower lobectomy for NSCLC\n* Minimally invasive thoracoscopic approach\n* Middle lobectomy excluded\n\nExclusion Criteria:\n\n* Induction radiochemotherapy or chemo-immunotherapy\n* Severe COPD: GOLD 3 or higher\n* Sleeve resection or extended resection involving other lobes\u002Fchest wall\u002Fpericardium, etc.\n* Albumin intolerance\u002Fallergy\n* Renal insufficiency\n* Redo surgery\n* Use of sealants\u002Fadhesives other than the study approach\n* Expected extensive pleural adhesions","ALL","18 Years","99 Years",{"count":175,"type":176},160,"ESTIMATED","INTERVENTIONAL",[179],"NA","This multicenter randomized trial evaluates whether routine use of Progel Platinum surgical sealant on stapled fissure lines during VATS upper or lower lobectomy for NSCLC reduces pleural drainage duration compared with standard stapling alone. Secondary objectives include postoperative length of stay, incidence and duration of postoperative air leaks, residual pleural space, safety outcomes, and hospitalization costs.",[182,183,184],"Non-Small Cell Lung Cancer","Postoperative Air Leak","NSCLC",[182,184,186,187,188,69,189,190],"VATS Lobectomy","Postoperative air leak","Pleural drainage","Surgical sealant","Thoracic surgery","2026-03-16",{"date":193,"type":194},"2026-03-18","ACTUAL",{"date":196,"type":194},"2026-02-27",{"date":198,"type":176},"2027-12-31",{"name":5,"class":6},6]