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

NCT06544200 | Completed

• 1 other identifier: 513n/AO24
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

thoracoscopic surgery; Segmentectomy; Air Leak; Hydrogel Matrix

Outcome Measures

Primary Outcomes (1)

• presence of postoperative air leaks

  The presence of postoperative air leaks from pleural drainage, from the end of surgery to the last day the air leaks are detected.

  days from end of surgery up to 40 days of postoperative follow-up

Secondary Outcomes (3)

• Chest drain length of stay

  days from the first postoperative day up to 40 days of postoperative follow-up

• In-Hospital length of stay

  days from the first postoperative day up to 40 days of postoperative follow-up

• Incidence of postoperative complications

  days from the first postoperative day up to 40 days of postoperative follow-up

Study Arms (2)

Polymeric Hydrogel Matrix

EXPERIMENTAL

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.

Device: Polymeric Hydrogel Matrix

Control Group

NO INTERVENTION

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.

Interventions

Polymeric Hydrogel Matrix DEVICE

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

Polymeric Hydrogel Matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Padova: lead

Study Sites (1)

Thoracic Surgery Unit

Padua, 35128, Italy

Location

Related Publications (4)

• 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.

  PMID: 23590942 BACKGROUND

• 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.

  PMID: 29312730 BACKGROUND

• 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.

  PMID: 31078312 BACKGROUND

• 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.

  PMID: 40543008 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Samuele Nicotra, MDF

  Thoracic Surgery Unit, University Hospital of Padua

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thoracic Surgeon

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 9, 2024
• Study Start: July 15, 2023
• Primary Completion: July 13, 2024
• Study Completion: July 13, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)