NCT04981938

Brief Summary

Lung cancer is the leading cause of cancer death worldwide. Despite the evolution of medical and multimodal treatments, surgical treatment remains the curative management in the localized cancer. Historically, in central lung tumors, pneumonectomy was the gold standard. Currently, bronchial sleeve lobectomy is recommended as first-line treatment over pneumonectomy when complete resection is possible (Grade 2C). In the case of pulmonary artery invasion, lobectomy with arterial resection and reconstruction is now an accepted option for central localized cancer. Despite surgical challenge, arterial sleeve lobectomy is oncologically comparable with pneumonectomy while avoiding the high morbi-mortality. Indeed, this surgery has shown better results than pneumonectomy in terms of overall survival, post-operative mortality, and quality of life. Initially performed in patients with impaired cardio-pulmonary reserves, this parenchymal sparing procedure can be realised in all patients, when anatomical conditions allow a complete resection. In the literature, no study has yet specifically investigated postoperative respiratory function after arterial sleeve lobectomy. The investigators designed a retrospective monocentric study at the University Hospital of Montpellier on 81 lobectomies with pulmonary artery sleeve resection for lung cancer, from January 2001 to December 2020.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 23, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 17, 2021

Status Verified

July 1, 2021

Enrollment Period

9 days

First QC Date

July 23, 2021

Last Update Submit

September 14, 2021

Conditions

Keywords

artery pulmonary reconstructionsleeve lobectomylobectomy with angioplastyarterial sleeve lobectomypulmonary function

Outcome Measures

Primary Outcomes (1)

  • Impact of pulmonary artery reconstruction on perfusion on the remaining lung lobe (ventilation/perfusion scan)

    Comparison of perfusion data on pre and post operative ventilation/perfusion scan

    2001-2020

Secondary Outcomes (3)

  • Impact of pulmonary artery reconstruction on pulmonary function

    2001-2020

  • pulmonary artery reconstruction patency

    2001-2020

  • Pulmonary function according to the type of reconstruction

    2001-2020

Study Arms (1)

Lobectomy with angioplasty

81 patients who underwent lobectomy with pulmonary artery reconstruction during oncologic lung resection from January 2001 to December 2020

Procedure: Lobectomy with pulmonary artery reconstruction

Interventions

Lobectomy with pulmonary artery reconstruction under general anesthesia with selective intubation, by postero-lateral thoracotomy in the fifth intercostal space Subgroups : different types of pulmonary artery reconstruction such as : * Tangential vascular reconstruction with direct suture * Circumferential resection and end-to-end anastomosis * bypass reconstruction with heterologous biografts, synthetic grafts, or pericardium patch

Lobectomy with angioplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes 81 patients: 18 womens, 63 mens There was no significant difference in patient characteristics. The most common resection was left upper lobectomy (52/81). 61 patients had a lung cancer with invasion of the left pulmonary artery. The most common histology was squamous cell carcinoma (42/81). 28 patients underwent a double sleeve (angioplasty and bronchoplasty) The type of arterial reconstruction was distributed as follows: * 25 bypass * 17 patch angioplasty * 16 circumferential resection and end-to-end anastomosis * 23 tangential vascular reconstruction with direct suture

You may qualify if:

  • all major lung resection with pulmonary artery reconstruction for lung cancer
  • from January 2001 to December 2020 at University Hospital of Montpellier
  • patient \> 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NGUYEN

Montpellier, 34000, France

Location

Related Publications (8)

  • D'Andrilli A, Maurizi G, Andreetti C, Ciccone AM, Ibrahim M, Poggi C, Venuta F, Rendina EA. Pulmonary artery reconstruction with pulmonary vein conduit for lung cancer: medium-term results. Ann Thorac Surg. 2014 Sep;98(3):990-5. doi: 10.1016/j.athoracsur.2014.04.110. Epub 2014 Jul 16.

    PMID: 25038016BACKGROUND
  • D'Andrilli A, Maurizi G, Ciccone AM, Andreetti C, Ibrahim M, Menna C, Vanni C, Venuta F, Rendina EA. Long-segment pulmonary artery resection to avoid pneumonectomy: long-term results after prosthetic replacement. Eur J Cardiothorac Surg. 2018 Feb 1;53(2):331-335. doi: 10.1093/ejcts/ezx353.

    PMID: 29029026BACKGROUND
  • Cerezo F, Cano JR, Espinosa D, Salvatierra A. New technique for pulmonary artery reconstruction. Eur J Cardiothorac Surg. 2009 Aug;36(2):422-3. doi: 10.1016/j.ejcts.2009.03.060. Epub 2009 Jun 5.

    PMID: 19501519BACKGROUND
  • Cerfolio RJ, Bryant AS. Surgical techniques and results for partial or circumferential sleeve resection of the pulmonary artery for patients with non-small cell lung cancer. Ann Thorac Surg. 2007 Jun;83(6):1971-6; discussion 1976-7. doi: 10.1016/j.athoracsur.2007.01.048.

    PMID: 17532380BACKGROUND
  • Galetta D, Borri A, Gasparri R, Petrella F, Spaggiari L. Surgical Techniques and Long-Term Results of Pulmonary Artery Reconstruction in Patients With Lung Cancer. Ann Thorac Surg. 2015 Oct;100(4):1196-202; discussion 1202. doi: 10.1016/j.athoracsur.2015.04.124. Epub 2015 Jul 21.

    PMID: 26209482BACKGROUND
  • Gomez-Caro A, Martinez E, Rodriguez A, Sanchez D, Martorell J, Gimferrer JM, Haverich A, Harringer W, Pomar JL, Macchiarini P. Cryopreserved arterial allograft reconstruction after excision of thoracic malignancies. Ann Thorac Surg. 2008 Dec;86(6):1753-61; discussion 1761. doi: 10.1016/j.athoracsur.2008.06.027.

    PMID: 19021970BACKGROUND
  • Ma Q, Liu D, Guo Y, Shi B, Tian Y, Song Z, Zhang Z, Ge B, Wang X, D'Amico TA. Surgical techniques and results of the pulmonary artery reconstruction for patients with central non-small cell lung cancer. J Cardiothorac Surg. 2013 Dec 1;8:219. doi: 10.1186/1749-8090-8-219.

    PMID: 24289720BACKGROUND
  • Madariaga MLL, Geller A, Lanuti M, Ott H, Allan JS, Donahue DM, Mathisen DJ, Wright CD, Gaissert HA. Pulmonary Artery Resection During Lung Resection for Malignancy. Ann Thorac Surg. 2019 Dec;108(6):1692-1700. doi: 10.1016/j.athoracsur.2019.05.079. Epub 2019 Jul 20.

    PMID: 31336066BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • SOLOVEI Laurence

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thoracic surgery resident

Study Record Dates

First Submitted

July 23, 2021

First Posted

July 29, 2021

Study Start

July 22, 2021

Primary Completion

July 31, 2021

Study Completion

September 1, 2021

Last Updated

September 17, 2021

Record last verified: 2021-07

Locations