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

Active, not recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06835231
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2024-10
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-09-11
• Study Completion: 2025-11-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication rate	through study completion, an average of 18 months	Rate of postoperative complication
Overall Survival	through study completion, an average of 18 months	Overall Survival, from the date of surgery to the latest follow up or death
Disease-Free Survival	through study completion, an average of 18 months	Disease Free Survival, from the date of surgery to the first appearance of local, regional and/or distant recurrence

Secondary Outcome Measures

Name	Time	Method
Early postoperative mortality	30 and 90 days from the day of surgery	Mortality rate at 30 and 90 days from the day of surgery
Re-hospitalization	30 days from the date of discharge	Rate of rehospitalization in the first 30 days after discharge

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero Universitaria di Bologna; 🇮🇹 Bologna, Emilia Romagna, Italy