Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection

NCT ID: NCT06544200

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2024-07-13

Brief Summary

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.

Detailed Description

The management of postoperative air leaks remains an unresolved issue in pulmonary resections. This complication can be present in up to 75% of patients undergoing major lung resections; however, it often resolves spontaneously. In 8% of cases, air leaks can persist for up to 5-7 days post-surgery, and are associated with a higher risk of complications, such as prolonged chest tube duration, increased incidence of postoperative infections and higher medical and non-medical costs. Sealants are non-invasive medical devices that help reduce or eliminate air leaks and bleeding. A recent study showed an increased risk of air leaks in patients undergoing segmentectomies compared to lobar resections; this study is designed to evaluate the efficacy of intraoperative use of Polymeric Hydrogel matrix in achieving aerostasis during anatomical segmental pulmonary resections via VATS or RATS, compared to patients receiving standard of care. All patients meet the eligibility criteria and successfully undergo a minimally invasive segmentectomy will undergo intraoperative evaluation of alveolar air leaks. Those with moderate 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), will be randomized to receive Polymeric Hydrogel matrix or no further treatment.The primary endpoint is to evaluate the efficacy in reducing postoperative air leaks secondary to the intraoperative application of Polymeric Hydrogel matrix (measured in days from the first postoperative day to the last day the air leaks are detected), compared to a control group receiving standard of care.The secondary endpoints include the evaluation of the postoperative permanence of chest tube, total length of hospital stay, medical and non-medical costs and postoperative complications up to 40 days of follow-up.

Conditions

Lung Cancer Stage I; Lung; Node; Air Leak From Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Polymeric Hydrogel Matrix

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.

Group Type: EXPERIMENTAL

Polymeric Hydrogel Matrix

Intervention Type: DEVICE

application of Polymeric Hydrogel Matrix along the suture line at the completion of lung resection

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Polymeric Hydrogel Matrix

application of Polymeric Hydrogel Matrix along the suture line at the completion of lung resection

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Padova

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Maria Comacchio

Thoracic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuele Nicotra, MDF

Role: PRINCIPAL_INVESTIGATOR

Thoracic Surgery Unit, University Hospital of Padua

Locations

Thoracic Surgery Unit

Padua, , Italy

Countries

Italy

References

Fuller 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.

Reference Type: BACKGROUND

PMID: 23590942 (View on PubMed)

Zaraca 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.

Reference Type: BACKGROUND

PMID: 29312730 (View on PubMed)

Suzuki 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.

Reference Type: BACKGROUND

PMID: 31078312 (View on PubMed)

Nicotra 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. 2025 Jun 21. doi: 10.1007/s13304-025-02291-1. Online ahead of print.

Reference Type: DERIVED

PMID: 40543008 (View on PubMed)

Other Identifiers

513n/AO24

Identifier Type: -

Identifier Source: org_study_id