Clinical trial NCT06544200: Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection
Official title: Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection: Randomized Comparison Between Polymeric Hydrogel Matrix and Standard of Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer Stage I
Lung; Node
Air Leak From Lung
Keywords: thoracoscopic surgery
Segmentectomy
Air Leak
Hydrogel Matrix
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: presence of postoperative air leaks
timeFrame: days from end of surgery up to 40 days of postoperative follow-up
Secondary outcomes:
measure: Chest drain length of stay
timeFrame: days from the first postoperative day up to 40 days of postoperative follow-up
measure: In-Hospital length of stay
timeFrame: days from the first postoperative day up to 40 days of postoperative follow-up
measure: Incidence of postoperative complications
timeFrame: days from the first postoperative day up to 40 days of postoperative follow-up
Other outcomes:
Locations:
city: Padua
country: Italy
facility: Thoracic Surgery Unit
Study officials:
affiliation: Thoracic Surgery Unit, University Hospital of Padua
name: Samuele Nicotra, MDF
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.