Clinical trial · Interventional
Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Postoperative Air Leak | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mechanical Stapling | Procedure | — | UNRESOLVED |
| Progel Platinum | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Progel Group (PG)
- description
- Fissure completion with mechanical staplers followed by application of Progel Platinum sealant along the fissure completion line.
- interventionNames
- Device: Progel Platinum
- type
- ACTIVE_COMPARATOR
- label
- Standard Treatment Group (ST)
- description
- Fissure completion with mechanical staplers alone, according to current standard practice.
- interventionNames
- Procedure: Mechanical Stapling
Primary outcomes (1)
- measure
- Duration of pleural drainage
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available