Clinical Trials Logo
  1. Home
  2. Lung Cancer, Nonsmall Cell
  3. NCT04981938
  4. Details
NCT04981938 Clinical Trial

Pulmonary Function After Arterial Sleeve Lobectomy

Lung Cancer, Nonsmall Cell Clinical Trial

Official title:
Perfusion and Functional Results After Pulmonary Artery Reconstruction During Oncologic Lung Resection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04981938
Other study ID # CHRUMontpellier
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 22, 2021
Est. completion date September 1, 2021

Study information
Verified date July 2021
Source Centre Hospitalier Régional Universitaire Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date September 1, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: 0

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Lobectomy with pulmonary artery reconstruction
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

Locations
Country Name City State
France NGUYEN Montpellier

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional Universitaire Montpellier

Country where clinical trial is conducted

France, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Gómez-Caro A, Martinez E, Rodríguez 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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Impact of pulmonary artery reconstruction on pulmonary function Comparison of post operative predicted FEV1 to post operative FEV1 2001-2020
Secondary pulmonary artery reconstruction patency Patency data of the arterial reconstruction (thoracic angioscan) 2001-2020
Secondary Pulmonary function according to the type of reconstruction Comparison of the results (FEV1 ans patency) according to the type of reconstruction 2001-2020
See also
  Status Clinical Trial Phase
Recruiting NCT06003075 - Induction Chemo-Nivo in Unresectable Stage III NSCLC Phase 2
Enrolling by invitation NCT06293833 - Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan N/A
Recruiting NCT03705806 - Palliative Thoracic ImmunoRT
Not yet recruiting NCT06060964 - Enabling Remote Access to Breathe Easier: A Novel Approach to Improve Symptom Management Early Phase 1
Completed NCT04634630 - The Influence of Cancer Stem-cells on Risk of Relapse in Patients Harboring Adenocarcinoma and Squamous Cell Carcinoma of the Lung
Completed NCT03689634 - Move For Surgery - A Novel Preconditioning Program Phase 3
Recruiting NCT05537922 - I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
Completed NCT03902834 - Move for Surgery (MFS): Evaluating the Use of Wearable Technology for Preconditioning Before Thoracic Surgery N/A
Active, not recruiting NCT03322072 - Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung TUmours Using Real-Time Tumour Tracking & Respiratory Gating N/A
Completed NCT02995889 - FLT-PET for Early Detection of Relapse in Patients With Irradiated Lung Cancer N/A
Recruiting NCT04237805 - A Phase I/II Clinical Study of SAF-189s in Non-small Cell Lung Cancer (NSCLC) Patients Phase 1/Phase 2
Terminated NCT05061940 - This SCR-103 Protocol Will Permit Sites to Proactively Assess TAA, HLA and HPV-16 Status in Patients With Selected Solid Tumors to Determine Suitability for Repertoire Immune Medicines Treatment Protocols.
Recruiting NCT05860296 - Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers Phase 1/Phase 2
Suspended NCT02991651 - Study of IRX4204 With Erlotinib in Previously Treated Advanced NSCLC Phase 1
Enrolling by invitation NCT04678440 - [18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients Early Phase 1
Recruiting NCT04222335 - Understanding and Overcoming the Early Adaptive Resistance to EGFR Tyrosine-kinase Inhibitors in Lung Cancer Patients N/A
Recruiting NCT04415320 - X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases Phase 2
Recruiting NCT02786589 - Plasmodium Immunotherapy for Lung Cancer Phase 1/Phase 2
Recruiting NCT05085028 - A Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Phase 3
Completed NCT05956782 - Breathe Easier II: A Dyad-based Multiple Behavior Intervention N/A

External Links