Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC
Recruiting · NCT07479277 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Mechanical StaplingProgel Platinum
What this trial is about
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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age ≥18 years
- Written informed consent
- Planned VATS upper or lower lobectomy for NSCLC
- Minimally invasive thoracoscopic approach
- Middle lobectomy excluded
Exclusion criteria
- Induction radiochemotherapy or chemo-immunotherapy
- Severe COPD: GOLD 3 or higher
- Sleeve resection or extended resection involving other lobes/chest wall/pericardium, etc.
- Albumin intolerance/allergy
- Renal insufficiency
- Redo surgery
- Use of sealants/adhesives other than the study approach
- Expected extensive pleural adhesions
Where it is running
6 locations listed.
- Ospedale centrale di Bolzano, Chirurgia Toracica e Vascolare - Bolzano, Italy
- Azienda Ospedaliero-Universitaria Careggi - Florence, Italy
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - Milan, Italy
- Irccs Ismett - Palermo, Italy
- Azienda Ospedaliera-Universitaria Pisana - Pisa, Italy
- Unità di Chirurgia Toracica Oncologica - Candiolo, Torino, Italy