Resectable Lung Non-Small Cell CarcinomaVaPosVentNCT06276530
Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling
A study testing EOS imaging for musculoskeletal disorder, Movement analysis by an optoelectronic camera. and Stabilometric measurement by strength platform in people with Resectable Lung Non-Small Cell Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims to identify physiopathologic mechanisms related to surgical approaches during lobectomies for non-small cell lung cancer which can explain the better quality of life and the decrease of of post-operative complications in minimally invasive techniques (video-assisted thoracic surgery and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Lung Non-Small Cell Carcinoma
- What is being tested?
- EOS imaging for musculoskeletal disorder, Movement analysis by an optoelectronic camera. and Stabilometric measurement by strength platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients admitted for major lung resection
- Surgical approach by conventional postern-lateral thoracotomy
- Surgical approach by minimally invasive RATS
Who cannot join
- Extended lung resection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of Thoracic and Vascular Surgery Tenon University Hospital
Paris, 75020
Harry ETIENNE, M.D., PhD, +33 6 67 96 82 89, h.etienne@hotmail.fr
About this study
This study aims to identify physiopathologic mechanisms related to surgical approaches during lobectomies for non-small cell lung cancer which can explain the better quality of life and the decrease of of post-operative complications in minimally invasive techniques (video-assisted thoracic surgery and robotic-assisted thoracic surgery) compared to conventional thoracotomy.
Read the detailed description
In 2018, 46363 new cases of lung cancers have been diagnosed in France. It is the second most frequent cancer in men and the third most frequent cancer in women. It is the deadliest cancer in men and second deadliest cancer in women with 33117 deaths in 2018. The gold standard treatment is lobectomy with lymph node dissection in patients with a resectable tumor. The main surgical approach has long been conventional thoracotomy. It is associated with prolonged post-operative pain and discomfort because of rib spreading which injures the intercostal nerve and a costo-transverse disjunction. Moreover, in patients with narrowed intercostal space or restrictive syndrome, cher is a high risk of rib fracture associated. Alternative surgical approaches have been developed to reduce the pain and discomfort during a lobectomy. Minimally invasive approaches are mainly represented by video-assisted thoracic surgery (VATS) and robotic-assisted thoracic surgery (RATS). These approaches are characterized by the use of an endoscope during the whole procedure associated with specific instruments and the absence of rib spreading. With these technique, a similar disease-specific long-term survival is obtained compared to conventional thoracotomy. These techniques also reduce post-operative complications, post-operative acute and chronic pain and improve the quality of life. The discomfort and the decrease in quality of life comes from the pain related to the incision but could also come from the postural dysfunction , more frequent and severe after conventional thoracotomy. The physiopathology behind this postural dysfunction are not well known but seem to be related to partially to the mechanical alteration of the rib cage and partially and because of a mechanical dysfunction related to the diaphragm following the surgery. The rib cage is an important element of postural stability. The diaphragm has a key role in both breathing and posture. Alterations of these structures dedicated to stability and ventilation are potentially associated with central mechanisms which end up in an adaptation of posture-respiratory coupling. By comparing conventional thoracotomy and VATS, it has been shown that lobectomy by VATS is associated with less disruption in posture and posture-respiratory coupling compared to thoracotomy. But no data hast yet compared RATS and conventional thoracotomy. The investigators hypothesized that RATS would cause less disruption in the postural alignment, in the perception of verticality and posture-respiratory coupling index (in static position and by walking) compared to conventional thoracotomy. In this context, the investigators aim to compare the effects of conventional thoracotomy with RATS on the rib cage and the posture-respiratory coupling.
- Conditions
- Resectable Lung Non-Small Cell Carcinoma
- Being tested
- EOS imaging for musculoskeletal disorder, Movement analysis by an optoelectronic camera., Stabilometric measurement by strength platform
- Keywords
- Posture-respiratory coupling,, Robotic-assisted thoracic surgery, Conventional thoracotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS imaging for musculoskeletal disorderOther
The patients will have a low radiation 2D/3D biplane imaging of the rib cage, and spine before and after surgery.
Movement analysis by an optoelectronic camera.Other
Movement analysis by an optoelectronic camera before and after surgery.
Stabilometric measurement by strength platformOther
Stabilometric measurement by strength platform before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Thoracotomy | Active comparator | The patients in this group will have a major lung resection through a conventional postero-lateral thoracotomy. Receives: Other: EOS imaging for musculoskeletal disorder; Other: Movement analysis by an optoelectronic camera.; Other: Stabilometric measurement by strength platform |
| RATS (robotic-assisted thoracoscopic surgery) | Active comparator | The patients in this group will have a major lung resection through a minimally invasive approach by RATS. Receives: Other: EOS imaging for musculoskeletal disorder; Other: Movement analysis by an optoelectronic camera.; Other: Stabilometric measurement by strength platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic kyphosis (T1- T12 angle) and vertical alignment head-pelvis and head- C7 vertebra (angle OD-HA and OD-C7) (EOS)
Variation between pre- and post-operative measurement
Measured: Assessment one week before surgery and 4 weeks surgery.
Secondary outcomes (4)
Width of rib cage (EOS)
Variation between pre- and post-operative measurement in centimeters
Measured: Assessment one week before surgery and 4 weeks after surgery.
Rib cage volume (EOS)
Variation between pre- and post-operative measurement in Liter
Measured: Assessment one week before surgery and 4 weeks after surgery.
" Umbrella "angle (EOS)
Variation between pre- and post-operative measurement
Measured: Assessment one week before surgery and 4 weeks after surgery
Center of Pressure displacement (Optoelectronic system)
Variation between pre- and post-operative measurement
Measured: Assessment one week before surgery and 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start25 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Resectable Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry ETIENNE, M.D., PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276530
- Sponsor's protocol ID
- APHP231036
- Acronym
- VaPosVent
- Status last verified
- Aug 2025
- First submitted
- 19 Dec 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pujol JL, Thomas PA, Giraud P, Denis MG, Tretarre B, Roch B, Bommart S. Lung Cancer in France. J Thorac Oncol. 2021 Jan;16(1):21-29. doi: 10.1016/j.jtho.2020.09.012. No abstract available.
PubMed 33384058Postmus PE, Kerr KM, Oudkerk M, Senan S, Waller DA, Vansteenkiste J, Escriu C, Peters S; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv1-iv21. doi: 10.1093/annonc/mdx222. No abstract available.
PubMed 28881918Cerfolio RJ, Price TN, Bryant AS, Sale Bass C, Bartolucci AA. Intracostal sutures decrease the pain of thoracotomy. Ann Thorac Surg. 2003 Aug;76(2):407-11; discussion 411-2. doi: 10.1016/s0003-4975(03)00447-8.
PubMed 12902074
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling
- ClinicalTrials.gov ID
- NCT06276530
- Acronym / sponsor ID
- VaPosVent / APHP231036
- Conditions
- Resectable Lung Non-Small Cell Carcinoma
- Keywords
- Posture-respiratory coupling,, Robotic-assisted thoracic surgery, Conventional thoracotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 26 Feb 2024 (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.
This study aims to identify physiopathologic mechanisms related to surgical approaches during lobectomies for non-small cell lung cancer which can explain the better quality of life and the decrease of of post-operative complications in minimally invasive techniques (video-assisted thoracic surgery and robotic-assisted thoracic surgery) compared to conventional thoracotomy.
Detailed description
In 2018, 46363 new cases of lung cancers have been diagnosed in France. It is the second most frequent cancer in men and the third most frequent cancer in women. It is the deadliest cancer in men and second deadliest cancer in women with 33117 deaths in 2018. The gold standard treatment is lobectomy with lymph node dissection in patients with a resectable tumor. The main surgical approach has long been conventional thoracotomy. It is associated with prolonged post-operative pain and discomfort because of rib spreading which injures the intercostal nerve and a costo-transverse disjunction. Moreover, in patients with narrowed intercostal space or restrictive syndrome, cher is a high risk of rib fracture associated. Alternative surgical approaches have been developed to reduce the pain and discomfort during a lobectomy. Minimally invasive approaches are mainly represented by video-assisted thoracic surgery (VATS) and robotic-assisted thoracic surgery (RATS). These approaches are characterized by the use of an endoscope during the whole procedure associated with specific instruments and the absence of rib spreading. With these technique, a similar disease-specific long-term survival is obtained compared to conventional thoracotomy. These techniques also reduce post-operative complications, post-operative acute and chronic pain and improve the quality of life. The discomfort and the decrease in quality of life comes from the pain related to the incision but could also come from the postural dysfunction , more frequent and severe after conventional thoracotomy. The physiopathology behind this postural dysfunction are not well known but seem to be related to partially to the mechanical alteration of the rib cage and partially and because of a mechanical dysfunction related to the diaphragm following the surgery. The rib cage is an important element of postural stability. The diaphragm has a key role in both breathing and posture. Alterations of these structures dedicated to stability and ventilation are potentially associated with central mechanisms which end up in an adaptation of posture-respiratory coupling. By comparing conventional thoracotomy and VATS, it has been shown that lobectomy by VATS is associated with less disruption in posture and posture-respiratory coupling compared to thoracotomy. But no data hast yet compared RATS and conventional thoracotomy. The investigators hypothesized that RATS would cause less disruption in the postural alignment, in the perception of verticality and posture-respiratory coupling index (in static position and by walking) compared to conventional thoracotomy. In this context, the investigators aim to compare the effects of conventional thoracotomy with RATS on the rib cage and the posture-respiratory coupling.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracotomy | Active comparator | Other: EOS imaging for musculoskeletal disorder, Other: Movement analysis by an optoelectronic camera., Other: Stabilometric measurement by strength platformThe patients in this group will have a major lung resection through a conventional postero-lateral thoracotomy. |
| RATS (robotic-assisted thoracoscopic surgery) | Active comparator | Other: EOS imaging for musculoskeletal disorder, Other: Movement analysis by an optoelectronic camera., Other: Stabilometric measurement by strength platformThe patients in this group will have a major lung resection through a minimally invasive approach by RATS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted for major lung resection
- Surgical approach by conventional postern-lateral thoracotomy
- Surgical approach by minimally invasive RATS
Key exclusion criteria (1 listed)
- Extended lung resection
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 |
|---|---|---|
| EOS imaging for musculoskeletal disorderThe patients will have a low radiation 2D/3D biplane imaging of the rib cage, and spine before and after surgery. | Other | RATS (robotic-assisted thoracoscopic surgery), Thoracotomy |
| Movement analysis by an optoelectronic camera.Movement analysis by an optoelectronic camera before and after surgery. | Other | RATS (robotic-assisted thoracoscopic surgery), Thoracotomy |
| Stabilometric measurement by strength platformStabilometric measurement by strength platform before and after surgery. | Other | RATS (robotic-assisted thoracoscopic surgery), Thoracotomy |
Primary outcome
Thoracic kyphosis (T1- T12 angle) and vertical alignment head-pelvis and head- C7 vertebra (angle OD-HA and OD-C7) (EOS)
Time frame: Assessment one week before surgery and 4 weeks surgery.
Variation between pre- and post-operative measurement
4 secondary outcomes
Width of rib cage (EOS)
Time frame: Assessment one week before surgery and 4 weeks after surgery.
Rib cage volume (EOS)
Time frame: Assessment one week before surgery and 4 weeks after surgery.
" Umbrella "angle (EOS)
Time frame: Assessment one week before surgery and 4 weeks after surgery
Center of Pressure displacement (Optoelectronic system)
Time frame: Assessment one week before surgery and 4 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 33384058Pujol JL, Thomas PA, Giraud P, Denis MG, Tretarre B, Roch B, Bommart S. Lung Cancer in France. J Thorac Oncol. 2021 Jan;16(1):21-29. doi: 10.1016/j.jtho.2020.09.012. No abstract available.
- Background: PubMed 28881918Postmus PE, Kerr KM, Oudkerk M, Senan S, Waller DA, Vansteenkiste J, Escriu C, Peters S; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv1-iv21. doi: 10.1093/annonc/mdx222. No abstract available.
- Background: PubMed 12902074Cerfolio RJ, Price TN, Bryant AS, Sale Bass C, Bartolucci AA. Intracostal sutures decrease the pain of thoracotomy. Ann Thorac Surg. 2003 Aug;76(2):407-11; discussion 411-2. doi: 10.1016/s0003-4975(03)00447-8.
- 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.
Harry ETIENNE, M.D., PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOS imaging for musculoskeletal disorder, Movement analysis by an optoelectronic camera. and Stabilometric measurement by strength platform in people with Resectable Lung Non-Small Cell Carcinoma, run by Assistance Publique - Hôpitaux de Paris 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harry ETIENNE, M.D., PhD Degree (06.67.96.82.89, harry.etienne@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic kyphosis (T1- T12 angle) and vertical alignment head-pelvis and head- C7 vertebra (angle OD-HA and OD-C7) (EOS) (time frame: Assessment one week before surgery and 4 weeks surgery.). 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 NCT06276530, which also lists 3 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 2 Sep 2025.