Lung Cancer, Nonsmall CellNCT04981938
Pulmonary Function After Arterial Sleeve Lobectomy
An observational study of Lung Cancer, Nonsmall Cell, run by Centre Hospitalier Régional Universitaire Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nonsmall Cell
- What is being tested?
- Lobectomy with pulmonary artery reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 0
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perfusion and Functional Results After Pulmonary Artery Reconstruction During Oncologic Lung Resection
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).
Read more
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.
- Conditions
- Lung Cancer, Nonsmall Cell
- Being tested
- Lobectomy with pulmonary artery reconstruction
- Keywords
- artery pulmonary reconstruction, sleeve lobectomy, lobectomy with angioplasty, arterial sleeve lobectomy, pulmonary function
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lobectomy with pulmonary artery reconstructionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Lobectomy with angioplasty | 81 patients who underwent lobectomy with pulmonary artery reconstruction during oncologic lung resection from January 2001 to December 2020 Receives: Procedure: Lobectomy with pulmonary artery reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2001-2020
Secondary outcomes (3)
Impact of pulmonary artery reconstruction on pulmonary function
Comparison of post operative predicted FEV1 to post operative FEV1
Measured: 2001-2020
pulmonary artery reconstruction patency
Patency data of the arterial reconstruction (thoracic angioscan)
Measured: 2001-2020
Pulmonary function according to the type of reconstruction
Comparison of the results (FEV1 ans patency) according to the type of reconstruction
Measured: 2001-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start22 Jul 2021
- Primary completion31 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer, Nonsmall CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Universitaire Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aude NGUYEN, Centre Hospitalier Régional Universitaire Montpellier
- Investigators
- SOLOVEI Laurence, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981938
- Sponsor's protocol ID
- CHRUMontpellier
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25038016D'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.
PubMed 29029026Cerezo 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.
PubMed 19501519Cerfolio 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.
PubMed 17532380Galetta 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.
PubMed 26209482Gomez-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.
PubMed 19021970Ma 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.
PubMed 24289720Madariaga 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.
PubMed 31336066
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion and Functional Results After Pulmonary Artery Reconstruction During Oncologic Lung Resection
- ClinicalTrials.gov ID
- NCT04981938
- Acronym / sponsor ID
- CHRUMontpellier
- Conditions
- Lung Cancer, Nonsmall Cell
- Keywords
- artery pulmonary reconstruction, sleeve lobectomy, lobectomy with angioplasty, arterial sleeve lobectomy, pulmonary function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Universitaire MontpellierUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lobectomy with angioplasty | – | Procedure: Lobectomy with pulmonary artery reconstruction81 patients who underwent lobectomy with pulmonary artery reconstruction during oncologic lung resection from January 2001 to December 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lobectomy with pulmonary artery reconstructionLobectomy 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 | Procedure or surgery | Lobectomy with angioplasty |
Primary outcome
Impact of pulmonary artery reconstruction on perfusion on the remaining lung lobe (ventilation/perfusion scan)
Time frame: 2001-2020
Comparison of perfusion data on pre and post operative ventilation/perfusion scan
3 secondary outcomes
Impact of pulmonary artery reconstruction on pulmonary function
Time frame: 2001-2020
pulmonary artery reconstruction patency
Time frame: 2001-2020
Pulmonary function according to the type of reconstruction
Time frame: 2001-2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Background: PubMed 25038016D'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.
- Background: PubMed 29029026D'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.
- Background: PubMed 19501519Cerezo 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.
- Background: PubMed 17532380Cerfolio 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.
- Background: PubMed 26209482Galetta 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.
- Background: PubMed 19021970Gomez-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.
- Background: PubMed 24289720Ma 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.
- Background: PubMed 31336066Madariaga 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SOLOVEI Laurence principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Nonsmall Cell, run by Centre Hospitalier Régional Universitaire Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of pulmonary artery reconstruction on perfusion on the remaining lung lobe (ventilation/perfusion scan) (time frame: 2001-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981938, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.