Progel Platinum to reduce air leaks after VATS lobectomy for NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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
• Email: andrea.droghetti@ircc.it
• Phone: 00390119933850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.