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Broncho-Vascular Lung Sparing Reconstructions and Pneumonectomies in Patients With Non Small Cell Lung Cancer

Broncho-vascular 'Lung Sparing' Reconstructions and Pneumonectomies in Patients With Non-small Cell Lung Cancer (Nsclc): Short-/Medium-term Results and Quality of Life

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06835231
Enrollment
140
Registered
2025-02-19
Start date
2022-10-01
Completion date
2025-11-11
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Brief summary

The aim of this study is to evaluate the medium- to long-term results of patients operated with bronchial and/or vascular sleeves. We will also evaluate the differences in terms of complications and medium-term results with patients undergoing pneumonectomy.

Detailed description

Many studies have confirmed the validity in functional and prognostic terms of resections lung 'lung-sparing' or 'broncho-vascular sleeve' resections), i.e. with sparing of lung parenchyma. This concept is applicable to small peripheral neoplasms for which there is increasing use of segmental resections instead of lobar resections, but above all - and this is the subject of the present study - for larger neoplasms and/or neoplasms that develop in the proximity of hilar structures with involvement of vascular-bronchial afferents. They are widely described in the literature as bronchial and vascular reconstruction techniques that allow both the preservation of a significant portion of lung parenchyma and consensually guarantee the surgical procedure's oncological radicality. In addition to the preservation of a functionally valid and effective portion of the lung, with the unquestionable benefits in terms of quality of life for the patient, this type of technique surgical technique with reconstruction offers an additional advantage, making it possible to avoid sacrificing sacrifice of the entire lung (pneumonectomy procedure), an operation that has a considerably higher morbidity and mortality rate. However, these techniques can also be associated with complications, some of them specific and inherent to (a) the bronchial anastomosis (which may go into dehiscence or stenosis) or b) arterial plastics (in its different forms and with different types of complications); finally, they are procedures that may entail technical surgical difficulties not negligible and are for this reason usually the prerogative of high-volume thoracic surgery centres. high-volume thoracic surgery centres. The scientific literature has often focused on long-term oncological outcomes, many studies are available in this regard. In contrast, fewer studies have focused on the short-to-medium-term results (peri-operative period and period within \<5aa) and the quality of life of life experienced by the patient after surgery. For example, the development of stenosis cicatricial stenosis of the bronchial anastomosis as well as other technique-specific issues (effectiveness of pulmonary vascular axis reconstruction) has only rarely been explored in detail. The aim of this study is to examine the characteristics and risk factors of patients undergoing sleeve surgery who subsequently developed anastomosis stenosis or technical complications in a broader sense and the results in terms of prognosis from an oncological point of view.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients aged 18 years or older (\>18 years) who underwent sleeve lung resection in the period between 01.01.2010 to 31.12.2020 for NSCLC. * For the group undergoing pneumonectomy patients aged 18 years or older (\>18 years) undergoing pneumonectomy for NSCLC will be included in the same period (01.01.2010 and 31.12.2020). * Informed consent for participation in the study.

Exclusion criteria

* Other neoplasm treated with chemotherapy in the 3 years prior to lung resection surgery. * Pathologic involvement N3 or stage IV

Design outcomes

Primary

MeasureTime frameDescription
Complication ratethrough study completion, an average of 18 monthsRate of postoperative complication
Overall Survivalthrough study completion, an average of 18 monthsOverall Survival, from the date of surgery to the latest follow up or death
Disease-Free Survivalthrough study completion, an average of 18 monthsDisease Free Survival, from the date of surgery to the first appearance of local, regional and/or distant recurrence

Secondary

MeasureTime frameDescription
Early postoperative mortality30 and 90 days from the day of surgeryMortality rate at 30 and 90 days from the day of surgery
Re-hospitalization30 days from the date of dischargeRate of rehospitalization in the first 30 days after discharge

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026