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

Not Applicable

Recruiting

• Conditions: Lung Cancer Stage I; Lung; Node; Air Leak From Lung
• Interventions: Device: Polymeric Hydrogel Matrix

• Registration Number: NCT06544200
• Lead Sponsor: University Hospital Padova

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.

Study Timeline

• Study Start: 2023-07-15
• Study First Submitted: 2024-07-30
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polymeric Hydrogel Matrix	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.

Primary Outcome Measures

Name	Time	Method
presence of postoperative air leaks	days from end of surgery up to 40 days of postoperative follow-up	The presence of postoperative air leaks from pleural drainage, from the end of surgery to the last day the air leaks are detected.

Secondary Outcome Measures

Name	Time	Method
In-Hospital length of stay	days from the first postoperative day up to 40 days of postoperative follow-up	The length of hospital stay, measured from the first postoperative day until the patient is discharged from the hospital ward
Chest drain length of stay	days from the first postoperative day up to 40 days of postoperative follow-up	The duration of pleural drainage placement from the first postoperative day until the day of its removal
Incidence of postoperative complications	days from the first postoperative day up to 40 days of postoperative follow-up	Any complications arising in patients are recorded and assigned a severity grade according to the Clavien-Dindo classification.

Trial Locations

Locations (1)

Thoracic Surgery Unit; 🇮🇹 Padua, Italy