Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC (E-SEAL)

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 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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer; NSCLC; Postoperative Air Leak
• Intervention / Treatment: Device: Progel Platinum; Procedure: Mechanical Stapling

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Droghetti MD; Phone Number: 00390119933850; Email: andrea.droghetti@ircc.it
• Study Contact Backup: Name: Annamaria Nuzzo PHD; Phone Number: 00390119933844; Email: annamaria.nuzzo@ircc.it

Study Locations

• Italy
  • Bolzano, Italy
    • Not yet recruiting
    • Ospedale centrale di Bolzano, Chirurgia Toracica e Vascolare
    • Contact: Francesco Zaraca
  • Florence, Italy
    • Not yet recruiting
    • Azienda Ospedaliero-Universitaria Careggi
    • Contact: Alessandro Gonfiotti
  • Milan, Italy
    • Not yet recruiting
    • Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
    • Contact: Mario Nosotti
  • Palermo, Italy
    • Not yet recruiting
    • Irccs Ismett
    • Contact: Alessandro Bertani
  • Pisa, Italy
    • Not yet recruiting
    • Azienda Ospedaliera-Universitaria Pisana
    • Contact: Marcello Carlo Ambrogi
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Recruiting
      • Unità di Chirurgia Toracica Oncologica
      • Contact: Andrea Droghetti, MD; Phone Number: +390119933850; Email: andrea.droghetti@ircc.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progel Group (PG); Fissure completion with mechanical staplers followed by application of Progel Platinum sealant along the fissure completion line.	Device: Progel Platinum; Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy
Active Comparator: Standard Treatment Group (ST); Fissure completion with mechanical staplers alone, according to current standard practice.	Procedure: Mechanical Stapling; Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of pleural drainage	Time from surgery to chest tube removal, measured in hours.	From surgery to chest tube removal, assessed up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hospital length of stay	Time from surgery to hospital discharge, measured in days.	From surgery to hospital discharge, assessed up to 30 days after surgery
Incidence and volume of postoperative air leaks	Proportion of patients with at least one documented postoperative air leak and mean daily and total postoperative air leak volume, as recorded by the digital drainage system.	Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
Incidence of residual pleural space	Proportion of patients with residual pleural space detected on chest imaging during postoperative hospitalization or at follow-up assessment.	During postoperative hospitalization and at follow-up visits at 1 month and 2 months after discharge
Postoperative safety outcomes	Incidence of postoperative adverse events and complications, including thoracentesis, new chest drainage, hospital readmission, and re-intervention.	During postoperative hospitalization and up to 30 days after surgery
Duration of postoperative air leak	Time from surgery to resolution of postoperative air leak, measured in hours.	From surgery to resolution of postoperative air leak during postoperative hospitalization, assessed up to 30 days after surgery
Duration of surgical procedure	Total duration of the surgical procedure, measured in minutes.	During the surgical procedure
Mean daily and total postoperative air leak volume	Mean daily postoperative air leak volume and cumulative total postoperative air leak volume, measured in liters using the digital drainage system.	Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
Air leak indices corrected for length of dissected pulmonary parenchyma	Quantitative postoperative air leak measures adjusted for the length of dissected pulmonary parenchyma to standardize comparisons between patients.	Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery

Collaborators and Investigators

• Sponsor: Fondazione del Piemonte per l'Oncologia

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2026
• Primary Completion (Estimated): February 27, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Non-Small Cell Lung Cancer; Thoracic surgery; Surgical sealant; VATS Lobectomy; Pleural drainage; Postoperative air leak; Progel Platinum
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 001-FPO26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No