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NCT Number: NCT07479277

Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms NSCLC Neoplasms Neoplasms by Site Postoperative Air Leak Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unità di Chirurgia Toracica Oncologica, Candiolo, Torino, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progel Platinum

Device

Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy

Mechanical Stapling

Procedure

Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Duration of surgical procedure

    Time frame: During the surgical procedure

    Total duration of the surgical procedure, measured in minutes.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Droghetti MD

CONTACT

[email protected]

00390119933850

Annamaria Nuzzo PHD

CONTACT

[email protected]

00390119933844

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study title

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

Acronym: E-SEAL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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