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NCT Number: NCT06835231

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, Emilia-Romagna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Complication rate

    Time frame: through study completion, an average of 18 months

    Rate of postoperative complication

  2. Overall Survival

    Time frame: through study completion, an average of 18 months

    Overall Survival, from the date of surgery to the latest follow up or death

  3. Disease-Free Survival

    Time frame: 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 outcomes

  1. Early postoperative mortality

    Time frame: 30 and 90 days from the day of surgery

    Mortality rate at 30 and 90 days from the day of surgery

  2. Re-hospitalization

    Time frame: 30 days from the date of discharge

    Rate of rehospitalization in the first 30 days after discharge

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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