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
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Age ≥18 years
• Written informed consent
• Planned VATS upper or lower lobectomy for NSCLC
• Minimally invasive thoracoscopic approach
• Middle lobectomy excluded
Locations
Other Locations
Italy
Ospedale centrale di Bolzano, Chirurgia Toracica e Vascolare
NOT_YET_RECRUITING
Bolzano
Unità di Chirurgia Toracica Oncologica
RECRUITING
Candiolo
Azienda Ospedaliero-Universitaria Careggi
NOT_YET_RECRUITING
Florence
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
Irccs Ismett
NOT_YET_RECRUITING
Palermo
Azienda Ospedaliera-Universitaria Pisana
NOT_YET_RECRUITING
Pisa
Contact Information
Primary
Andrea Droghetti MD
andrea.droghetti@ircc.it
00390119933850
Backup
Annamaria Nuzzo PHD
annamaria.nuzzo@ircc.it
00390119933844
Time Frame
Start Date: 2026-02-27
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 160
Treatments
Experimental: Progel Group (PG)
Fissure completion with mechanical staplers followed by application of Progel Platinum sealant along the fissure completion line.
Active_comparator: Standard Treatment Group (ST)
Fissure completion with mechanical staplers alone, according to current standard practice.
Related Therapeutic Areas
Sponsors
Leads: Fondazione del Piemonte per l'Oncologia