Progel Platinum to reduce air leaks 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

This trial will test whether applying Progel Platinum to stapled fissure lines during minimally invasive lobectomy for NSCLC shortens the time patients need chest drainage.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Fondazione del Piemonte per l'Oncologia (other)
• Drugs / interventions: immunotherapy
• Locations: 6 sites (Candiolo, Torino and 5 other locations)
• Trial ID: NCT07479277 on ClinicalTrials.gov

What this trial studies

E-SEAL is a prospective, randomized, controlled, multicenter trial that randomizes adults undergoing minimally invasive VATS upper or lower lobectomy for NSCLC 1:1 to standard stapling alone or stapling plus Progel Platinum sealant. The primary endpoint is pleural drainage duration in hours, and secondary endpoints include postoperative length of stay, air-leak incidence and duration, residual pleural space, complications, re-interventions, hospitalization costs, and follow-up up to 60 days after surgery or discharge. The trial is being conducted across multiple thoracic surgery centers in Italy with standardized operative and follow-up procedures. Eligible patients are screened to exclude those with factors likely to confound outcomes such as severe COPD, prior thoracic surgery, extensive adhesions, or induction chemo-radiotherapy.

Who should consider this trial

Good fit: Adults (≥18) scheduled for minimally invasive VATS upper or lower lobectomy for NSCLC who can provide informed consent and are not planned for middle, sleeve, or extended resections are the intended participants.

Not a fit: Patients with severe COPD (GOLD 3+), expected extensive pleural adhesions, redo or extended resections, renal insufficiency, albumin allergy, or prior induction radiochemotherapy are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If effective, the sealant could reduce chest tube duration, shorten hospital stays, and lower postoperative complications and costs.

How similar studies have performed: Preliminary non-randomized reports suggest Progel Platinum may reduce postoperative air leaks, but randomized controlled evidence has been limited until this multicenter trial.

Eligibility criteria

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 this trial is running

Candiolo, Torino and 5 other locations

• Unità di Chirurgia Toracica Oncologica — Candiolo, Torino, Italy (RECRUITING)
• Ospedale centrale di Bolzano, Chirurgia Toracica e Vascolare — Bolzano, Italy (NOT_YET_RECRUITING)
• Azienda Ospedaliero-Universitaria Careggi — Florence, Italy (NOT_YET_RECRUITING)
• Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan, Italy (NOT_YET_RECRUITING)
• Irccs Ismett — Palermo, Italy (NOT_YET_RECRUITING)
• Azienda Ospedaliera-Universitaria Pisana — Pisa, Italy (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Andrea Droghetti MD

Conditions: Non-Small Cell Lung Cancer, Postoperative Air Leak, NSCLC, VATS Lobectomy, Postoperative air leak, Pleural drainage, Progel Platinum, Surgical sealant