Non-Small Cell Lung Cancer, NSCLC, Postoperative Air Leak
Conditions
Keywords
Non-Small Cell Lung Cancer, NSCLC, VATS Lobectomy, Postoperative air leak, Pleural drainage, Progel Platinum, Surgical sealant, Thoracic surgery
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.
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
DEVICEProgel Platinum
Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy
PROCEDUREMechanical Stapling
Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.
Sponsors
Fondazione del Piemonte per l'Oncologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of pleural drainage | From surgery to chest tube removal, assessed up to 30 days after surgery | Time from surgery to chest tube removal, measured in hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative hospital length of stay | From surgery to hospital discharge, assessed up to 30 days after surgery | Time from surgery to hospital discharge, measured in days. |
| 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 | 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. |
| Incidence of residual pleural space | 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. |
| Postoperative safety outcomes | 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. |
| Duration of postoperative air leak | 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. |
| Duration of surgical procedure | During the surgical procedure | Total duration of the surgical procedure, measured in minutes. |
| Mean daily and total postoperative air leak volume | 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. |
| Air leak indices corrected for length of dissected pulmonary parenchyma | 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. |
Countries
Italy
Contacts
CONTACTAndrea Droghetti MD
CONTACTAnnamaria Nuzzo PHD
Outcome results
None listed