Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC

NCT07479277 | Recruiting DMC

• 1 other identifier: 001-FPO26
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer; Postoperative Air Leak; NSCLC

Keywords

Non-Small Cell Lung Cancer; NSCLC; VATS Lobectomy; Postoperative air leak; Pleural drainage; Progel Platinum; Surgical sealant; Thoracic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Postoperative hospital length of stay

  From surgery to hospital discharge, assessed up to 30 days after surgery

• Incidence and volume of postoperative air leaks

  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

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

• Postoperative safety outcomes

  During postoperative hospitalization and up to 30 days after surgery

• Duration of postoperative air leak

  From surgery to resolution of postoperative air leak during postoperative hospitalization, assessed up to 30 days after surgery

Study Arms (2)

Progel Group (PG)

EXPERIMENTAL

Fissure completion with mechanical staplers followed by application of Progel Platinum sealant along the fissure completion line.

Device: Progel Platinum

Standard Treatment Group (ST)

ACTIVE COMPARATOR

Fissure completion with mechanical staplers alone, according to current standard practice.

Procedure: Mechanical Stapling

Interventions

Progel Platinum DEVICE

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

Progel Group (PG)

Mechanical Stapling PROCEDURE

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

Standard Treatment Group (ST)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Written informed consent
• Planned VATS upper or lower lobectomy for NSCLC
• Minimally invasive thoracoscopic approach
• Middle lobectomy excluded

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (6)

Unità di Chirurgia Toracica Oncologica

Candiolo, Torino, 10060, 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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Andrea Droghetti MD

CONTACT

00390119933850; andrea.droghetti@ircc.it

Annamaria Nuzzo PHD

CONTACT

00390119933844; annamaria.nuzzo@ircc.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients undergoing VATS upper or lower lobectomy for NSCLC are randomized 1:1 intraoperatively to either standard fissure completion with mechanical staplers alone (control group) or mechanical staplers plus Progel Platinum sealant (experimental group). The study is multicenter and will be conducted in 8 thoracic surgery centers.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 18, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): February 27, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

IT (6)