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

NCT06835231 | Active Not Recruiting

• 1 other identifier: SP2021
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Complication rate

  Rate of postoperative complication

  through study completion, an average of 18 months

• Overall Survival

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

  through study completion, an average of 18 months

• Disease-Free Survival

  Disease Free Survival, from the date of surgery to the first appearance of local, regional and/or distant recurrence

  through study completion, an average of 18 months

Secondary Outcomes (2)

• Early postoperative mortality

  30 and 90 days from the day of surgery

• Re-hospitalization

  30 days from the date of discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, Emilia-Romagna, 40138, Italy

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pietro Bertoglio, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 19, 2025
• Study Start: October 1, 2022
• Primary Completion: September 11, 2025
• Study Completion: November 11, 2025
• Last Updated: February 19, 2025

Record last verified: 2024-10

Locations

IT (1)