RecruitingNot ApplicableNCT07479277

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


Sponsor

Fondazione del Piemonte per l'Oncologia

Enrollment

160 participants

Start Date

Feb 27, 2026

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria5

  • Age ≥18 years
  • Written informed consent
  • Planned VATS upper or lower lobectomy for NSCLC
  • Minimally invasive thoracoscopic approach
  • Middle lobectomy excluded

Exclusion Criteria8

  • 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

Interventions

DEVICEProgel Platinum

Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy

PROCEDUREMechanical Stapling

Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.


Locations(6)

Unità di Chirurgia Toracica Oncologica

Candiolo, Torino, Italy

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07479277