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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Fondazione del Piemonte per l'Oncologia · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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/discharge.

Conditions

• Non-Small Cell Lung Cancer
• Postoperative Air Leak
• NSCLC

Interventions

Type	Name	Description
DEVICE	Progel Platinum	Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy
PROCEDURE	Mechanical Stapling	Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.

Timeline

• Start date: 2026-02-27
• Primary completion: 2027-02-27
• Completion: 2027-12-31
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

6 sites across 1 country: Italy