Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Progel Platinum, Mechanical Stapling.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer, Postoperative Air Leak, NSCLC. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
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.
Interventions
- Device Progel Platinum
Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy - Procedure Mechanical Stapling
Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.
Primary outcome measures
- Duration of pleural drainage [Time frame: From surgery to chest tube removal, assessed up to 30 days after surgery]
Secondary outcome measures (8)
- Postoperative hospital length of stay [Time frame: 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]
- Incidence of residual pleural space [Time frame: 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]
- 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]
- Duration of surgical procedure [Time frame: 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 6 centers
- Unità di Chirurgia Toracica Oncologica — Candiolo
- Ospedale centrale di Bolzano, Chirurgia Toracica e Vascolare — Bolzano
- Azienda Ospedaliero-Universitaria Careggi — Florence
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan
- Irccs Ismett — Palermo
- Azienda Ospedaliera-Universitaria Pisana — Pisa
Identifiers
NCT: NCT07479277 · 001-FPO26