Health TrialsbyHealthPanel

Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC

ConditionsNon-Small Cell Lung CancerPostoperative Air LeakNSCLC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorFondazione del Piemonte per l'Oncologia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Written informed consent

Planned VATS upper or lower lobectomy for NSCLC

Minimally invasive thoracoscopic approach

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Progel Group (PG)Experimental treatment 1 intervention
Group B: Standard Treatment Group (ST)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of pleural drainage

Time from surgery to chest tube removal, measured in hours.

Time frame
From surgery to chest tube removal, assessed up to 30 days after surgery

Secondary outcomes

1

Postoperative hospital length of stay

Time from surgery to hospital discharge, measured in days.

Time frame
From surgery to hospital discharge, assessed up to 30 days after surgery
2

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.

Time frame
Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
3

Incidence of residual pleural space

Proportion of patients with residual pleural space detected on chest imaging during postoperative hospitalization or at follow-up assessment.

Time frame
During postoperative hospitalization and at follow-up visits at 1 month and 2 months after discharge
4

Postoperative safety outcomes

Incidence of postoperative adverse events and complications, including thoracentesis, new chest drainage, hospital readmission, and re-intervention.

Time frame
During postoperative hospitalization and up to 30 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione del Piemonte per l'Oncologia

Lead sponsor

Source ClinicalTrials.gov
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