Clinical trial · Interventional
Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection
Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection: Randomized Comparison Between Polymeric Hydrogel Matrix and Standard of Care
- 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)
In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), a still unsolved issue is represented by intraoperative alveolar air leaks (IOAALs), which if prolonged beyond the fifth postoperative day can lead to higher risk of complications and higher medical costs. The polymeric hydrogel matrix (PHM) is a novel tool to manage intraoperative IOAALs. The primary end-point of our study was to verify whether PHM would be able to reduce postoperative air leaks; secondary end-points were the possible reduction of the permanence time of the chest drain (CD) and the hospital length (HL) in the PHM group compared with no treatment.
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 |
|---|---|---|---|
| Air Leak From Lung | — | UNRESOLVED | — |
| Lung Cancer Stage I | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Lung; Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polymeric Hydrogel Matrix | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Polymeric Hydrogel Matrix
- description
- single application of Polymeric Hydrogel Matrix at the completion of lung resection, in patients with moderate intraoperative alveolar air leaks (30-60 ml/respiratory act), measured at the Ventilation Mechanical Test, which consists in 1 minute volumetric ventilation with a constant flow and a peak pressure of 22 cmH2O, 12 respiratory rates per minute and a positive end-expiratory pressure (PEEP) of 5 cmH2O.
- interventionNames
- Device: Polymeric Hydrogel Matrix
- type
- NO_INTERVENTION
- label
- Control Group
- description
- no further treatment at the completion of lung resection, in patients with moderate intraoperative alveolar air leaks (30-60 ml/respiratory act), measured at the Ventilation Mechanical Test, which consists in 1 minute volumetric ventilation with a constant flow and a peak pressure of 22 cmH2O, 12 respiratory rates per minute and a positive end-expiratory pressure (PEEP) of 5 cmH2O.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients aged \> 18 years * undergoing anatomical pulmonary resection (segmentectomy) via VATS or RATS * benign and/or malignant lung disease * No known allergy to any of the components of the device Exclusion Criteria: * Refusal or inability to give informed consent to the study protocol * Age \< 18 years * Pregnancy * Chronic Kidney Failure * Allergies or contraindications to any of the Polymeric Hydrogel Matrix components * Patients undergoing pulmonary resections different than segmentectomy (wedge, lobectomy, bilobectomy, pneumonectomy) * Patients undergoing open surgery * More than one chest tube after lung resection
References
Publications (4)
- BACKGROUNDFuller C. Reduction of intraoperative air leaks with Progel in pulmonary resection: a comprehensive review. J Cardiothorac Surg. 2013 Apr 16;8:90. doi: 10.1186/1749-8090-8-90. PMID 23590942
- BACKGROUNDZaraca F, Vaccarili M, Zaccagna G, Maniscalco P, Dolci G, Feil B, Perkmann R, Bertolaccini L, Crisci R. Cost-effectiveness analysis of sealant impact in management of moderate intraoperative alveolar air leaks during video-assisted thoracoscopic surgery lobectomy: a multicentre randomised controlled trial. J Thorac Dis. 2017 Dec;9(12):5230-5238. doi: 10.21037/jtd.2017.11.109. PMID 29312730
- BACKGROUNDSuzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9. PMID 31078312
- DERIVEDNicotra S, Comacchio GM, Mammana M, Sambataro V, Pagliarini G, Bonis A, Boemo D, Bovo P, Rebusso A, Schiavon M, Cannone G, Faccioli E, Dell'Amore A, Rea F. Air leaks management using polymeric hydrogel matrix after thoracoscopic lung segmentectomy: a single-center prospective randomized trial with a cost-effective analysis. Updates Surg. 2026 Apr;78(2):953-959. doi: 10.1007/s13304-025-02291-1. Epub 2025 Jun 21. PMID 40543008