Clinical trial NCT06835231: Broncho-Vascular Lung Sparing Reconstructions and Pneumonectomies in Patients With Non Small Cell Lung Cancer
Official title: Broncho-vascular 'Lung Sparing' Reconstructions and Pneumonectomies in Patients With Non-small Cell Lung Cancer (Nsclc): Short-/Medium-term Results and Quality of Life
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing sleeve lobectomy or pneumonectomy at the O.U. of Thoracic Surgery of the IRCCS Azienda Ospedaliero Universitaria di Bologna from 01.01.2010 to 31.12.2020.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication rate
timeFrame: through study completion, an average of 18 months
measure: Overall Survival
timeFrame: through study completion, an average of 18 months
measure: Disease-Free Survival
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
measure: Early postoperative mortality
timeFrame: 30 and 90 days from the day of surgery
measure: Re-hospitalization
timeFrame: 30 days from the date of discharge
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria di Bologna
state: Emilia Romagna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pietro Bertoglio, MD
role: PRINCIPAL_INVESTIGATOR
References: