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

March 16, 2026 updated by: Fondazione del Piemonte per l'Oncologia

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 Frame: From surgery to chest tube removal, assessed up to 30 days after surgery
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 Frame: From surgery to hospital discharge, assessed up to 30 days after surgery
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
Time Frame: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
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
Time Frame: During postoperative hospitalization and at follow-up visits at 1 month and 2 months after discharge
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
Time Frame: During postoperative hospitalization and up to 30 days after surgery
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 Frame: From surgery to resolution of postoperative air leak during postoperative hospitalization, assessed up to 30 days after surgery
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
Time Frame: During the surgical procedure
Total duration of the surgical procedure, measured in minutes.
During the surgical procedure
Mean daily and total postoperative air leak volume
Time Frame: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
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
Time Frame: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione del Piemonte per l'Oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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