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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progel Group (PG) | Experimental | Fissure completion with mechanical staplers followed by application of Progel Platinum sealant along the fissure completion line. |
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| Standard Treatment Group (ST) | Active Comparator | Fissure completion with mechanical staplers alone, according to current standard practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progel Platinum | Device | Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative hospital length of stay | Time from surgery to hospital discharge, measured in days. | From surgery to hospital discharge, assessed up to 30 days after surgery |
| Incidence and volume of postoperative air leaks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Droghetti MD | Contact | 00390119933850 | andrea.droghetti@ircc.it | |
| Annamaria Nuzzo PHD | Contact | 00390119933844 | annamaria.nuzzo@ircc.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unità di Chirurgia Toracica Oncologica | Recruiting | Candiolo | Torino | 10060 | Italy |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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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.
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| Mechanical Stapling | Procedure | Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy. |
|
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.
| 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 | Proportion of patients with residual pleural space detected on chest imaging during postoperative hospitalization or at follow-up assessment. | During postoperative hospitalization and at follow-up visits at 1 month and 2 months after discharge |
| Postoperative safety outcomes | Incidence of postoperative adverse events and complications, including thoracentesis, new chest drainage, hospital readmission, and re-intervention. | During postoperative hospitalization and up to 30 days after surgery |
| Duration of postoperative air leak | Time from surgery to resolution of postoperative air leak, measured in hours. | From surgery to resolution of postoperative air leak during postoperative hospitalization, assessed up to 30 days after surgery |
| Duration of surgical procedure | Total duration of the surgical procedure, measured in minutes. | During the surgical procedure |
| Mean daily and total postoperative air leak volume | Mean daily postoperative air leak volume and cumulative total postoperative air leak volume, measured in liters using the digital drainage system. | 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 | Quantitative postoperative air leak measures adjusted for the length of dissected pulmonary parenchyma to standardize comparisons between patients. | Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery |
| Ospedale centrale di Bolzano, Chirurgia Toracica e Vascolare | Not yet recruiting | Bolzano | Italy |
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| Azienda Ospedaliero-Universitaria Careggi | Not yet recruiting | Florence | Italy |
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| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Not yet recruiting | Milan | Italy |
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| Irccs Ismett | Not yet recruiting | Palermo | Italy |
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| Azienda Ospedaliera-Universitaria Pisana | Not yet recruiting | Pisa | Italy |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |