Lung CancerLungSco01NCT02502318
Medicoeconomic Evaluation of Two Surgical Techniques for Lobectomy in the Lung Cancer
A study testing Video-thoracoscopy and thoracotomy in people with Lung Cancer and Lobectomy, run by Centre Hospitalier Universitaire Dijon at 10 sites in France.
Trial summary
This is a national study that involves the participation of 600 lung cancer patients indicated that treatment is ablation of the pulmonary lobe. This technique is called lobectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lobectomy
- What is being tested?
- Video-thoracoscopy and thoracotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 10 sitesFrance
- Study dates
- 29 Jul 2015to 8 Oct 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patients who have given their consent
- Any patient with proven or suspected lung cancer treated by lobectomy or segmentectomy.
- Patients with a negative mediastinoscopy or negative " EBUS-EUS " following a PET scan showing uptake in mediastinal lymph nodes in the preoperative examination.
- Age ≥ 18 years
- Patient affiliated to a social security regimen
- Patients with a WHO performance status equal to 0 or 1.
Who cannot join
- Adults under wardship
- Pregnant or breast-feeding women
- Tumours in contact with the pulmonary artery or developing in the lobar bronchi after bronchial fibroscopy.
- Tumours in contact with the costal periosteum or invading the chest wall
- Tumours invading the mediastinal pleura or structures of the mediastinium (superior vena cava, trachea, the main-stem bronchi, aorta, oesophagus, vertebrae)
- Tumours invading the diaphragm
Show all 21Show fewer
- Tumours invading the neurovascular structures of the apex (brachial plexus, subclavicular artery, subclavicular vein) causing Pancoast-Tobias syndrome
- Patients with histologically-proven contralateral or supraclavicular lymph node (N3) involvement whatever the harvesting method.
- Patients with a positive mediastinoscopy or positive "EBUS-EUS" following a "PET scan" with uptake in one or more mediastinal lymph nodes.
- Patients with metastasis (brain, bone, liver, adrenal glands, contralateral lung, pleura).
- Patients who have undergone neo-adjuvant chemotherapy and/or radiotherapy.
- Patients included in a neo-adjuvant chemotherapy and/or radiotherapy protocol.
- Patients who have already undergone thoracotomy.
- Patients with decompensated heart failure or with a systolic ejection fraction below 30%.
- Patients with severe pulmonary artery hypertension.
- Patients with untreated valve disease.
- Patients with unstable angina despite appropriate treatment.
- Patients with untreated carotid stenosis greater than 70%.
- Patients with histologically proven cirrhosis with various decompensations or who have presented haemoptysis because of oesophageal varicose veins.
- Patients with severe neurological sequellae (hemiplegia, paraplegia, tetraplegia).
- Patients presenting severe psychiatric disorders (dementia, psychosis).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CH Victor Dupouy
Argenteuil
CH Avignon
Avignon
Centre Jean Perrin - Clermont-Ferrand
Clermont-Ferrand, 63000
CHU Dijon
Dijon, 21079
HCL - Louis Pradel
Lyon
APHM Hôpital Nord
Marseille, 13015
CHU de Montpellier
Montpellier, 34295
APHP Hôpital Cochin
Paris, 75014
CHU de Rennes - Hôpital de Pontchaillou
Rennes, 35000
CHU de Rouen
Rouen, 76031
About this study
Official title: Medicoeconomic Analysis of Lobectomy Using Thoracoscopy vs Thoracotomy for Lung Cancer: a Multicentric Randomized Controlled Trial.
This is a national study that involves the participation of 600 lung cancer patients indicated that treatment is ablation of the pulmonary lobe. This technique is called lobectomy.
Lobectomy may be performed in two different ways:
Read more
- Thoracotomy, which is the first reference approach and that is to make a large incision in the chest to pass between the ribs and spread the order to ablate the lobe.
- By video-thoracoscopy, which is a new surgical approach consisting in practice several small incisions in the chest wall to allow the introduction of a camera and special instruments to ablate the lobe.
The mini-invasive nature of video-thoracoscopy has a positive impact on postoperative expectoration and ventilation. As a result, the incidence of postoperative respiratory complications including atelectasis, pneumonia and Acute Respiratory Distress Syndrome (ARDS) is reduced. These respiratory complications are responsible for prolonged stays in Intensive Care Unit (ICU) and overall hospitalisation. It also has an impact on recovery and quality of life when patients return home. The reduction in the incidence of complications should counterbalance the additional cost of video-thoracoscopy.
This study aims to evaluate the effectiveness of these two techniques in relation to the quality of life and the costs they generate.
Patients who agree to participate in the study were assigned to one or other of these groups (technical thoracotomy or video-thoracoscopy technique) by lot.
- Conditions
- Lung Cancer, Lobectomy
- Being tested
- Video-thoracoscopy, thoracotomy
- Keywords
- Proven or suspected lung cancer treated by lobectomy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-thoracoscopyProcedure or surgery
thoracotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Lobectomy or segmentectomy using video-thoracoscopy | Experimental | Not described Receives: Procedure: Video-thoracoscopy |
| Lobectomy or segmentectomy using thoracotomy | Active comparator | Not described Receives: Procedure: thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The postoperative respiratory complications
Measured: 30 days after surgery
An incremental cost-utility ratio associated with the use of Video-Assisted Thoracic Surgery when compared with thoracotomy evaluated using the quality of life questionnary EQ-5D
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study start29 Jul 2015
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Why it stopped: lack of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502318
- Sponsor's protocol ID
- BERNARD PRME 2014
- Acronym
- LungSco01
- Status last verified
- Jan 2024
- First submitted
- 15 Jul 2015
- Last updated
- 12 Jan 2024
- Results posted
- No
Publications
Soilly AL, Aho Glele LS, Bernard A, Abou Hanna H, Filaire M, Magdaleinat P, Marty-Ane C, Tronc F, Grima R, Baste JM, Thomas PA, Richard De Latour B, Pforr A, Pages PB. Medico-economic impact of thoracoscopy versus thoracotomy in lung cancer: multicentre randomised controlled trial (Lungsco01). BMC Health Serv Res. 2023 Sep 18;23(1):1004. doi: 10.1186/s12913-023-09962-y.
PubMed 37723516Pages PB, Abou Hanna H, Bertaux AC, Serge Aho LS, Magdaleinat P, Baste JM, Filaire M, de Latour R, Assouad J, Tronc F, Jayle C, Mouroux J, Thomas PA, Falcoz PE, Marty-Ane CH, Bernard A. Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01). BMJ Open. 2017 Jun 15;7(6):e012963. doi: 10.1136/bmjopen-2016-012963.
PubMed 28619764
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medicoeconomic Analysis of Lobectomy Using Thoracoscopy vs Thoracotomy for Lung Cancer: a Multicentric Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02502318
- Acronym / sponsor ID
- LungSco01 / BERNARD PRME 2014
- Conditions
- Lung Cancer, Lobectomy
- Keywords
- Proven or suspected lung cancer treated by lobectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusions
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 20 Jul 2015 (estimated)
- 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 is a national study that involves the participation of 600 lung cancer patients indicated that treatment is ablation of the pulmonary lobe. This technique is called lobectomy.
Lobectomy may be performed in two different ways:
- Thoracotomy, which is the first reference approach and that is to make a large incision in the chest to pass between the ribs and spread the order to ablate the lobe.
- By video-thoracoscopy, which is a new surgical approach consisting in practice several small incisions in the chest wall to allow the introduction of a camera and special instruments to ablate the lobe.
The mini-invasive nature of video-thoracoscopy has a positive impact on postoperative expectoration and ventilation. As a result, the incidence of postoperative respiratory complications including atelectasis, pneumonia and Acute Respiratory Distress Syndrome (ARDS) is reduced. These respiratory complications are responsible for prolonged stays in Intensive Care Unit (ICU) and overall hospitalisation. It also has an impact on recovery and quality of life when patients return home. The reduction in the incidence of complications should counterbalance the additional cost of video-thoracoscopy.
This study aims to evaluate the effectiveness of these two techniques in relation to the quality of life and the costs they generate.
Patients who agree to participate in the study were assigned to one or other of these groups (technical thoracotomy or video-thoracoscopy technique) by lot.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lobectomy or segmentectomy using video-thoracoscopy | Experimental | Procedure: Video-thoracoscopy |
| Lobectomy or segmentectomy using thoracotomy | Active comparator | Procedure: thoracotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have given their consent
- Any patient with proven or suspected lung cancer treated by lobectomy or segmentectomy.
- Patients with a negative mediastinoscopy or negative " EBUS-EUS " following a PET scan showing uptake in mediastinal lymph nodes in the preoperative examination.
- Age ≥ 18 years
- Patient affiliated to a social security regimen
Key exclusion criteria (21 listed)
- Adults under wardship
- Pregnant or breast-feeding women
- Tumours in contact with the pulmonary artery or developing in the lobar bronchi after bronchial fibroscopy.
- Tumours in contact with the costal periosteum or invading the chest wall
- Tumours invading the mediastinal pleura or structures of the mediastinium (superior vena cava, trachea, the main-stem bronchi, aorta, oesophagus, vertebrae)
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 |
|---|---|---|
| Video-thoracoscopy | Procedure or surgery | Lobectomy or segmentectomy using video-thoracoscopy |
| thoracotomy | Procedure or surgery | Lobectomy or segmentectomy using thoracotomy |
Primary outcome
The postoperative respiratory complications
Time frame: 30 days after surgery
An incremental cost-utility ratio associated with the use of Video-Assisted Thoracic Surgery when compared with thoracotomy evaluated using the quality of life questionnary EQ-5D
Time frame: 3 months after surgery
Results and safety
The study was stopped early (reason given: lack of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Derived from this study: PubMed 37723516Soilly AL, Aho Glele LS, Bernard A, Abou Hanna H, Filaire M, Magdaleinat P, Marty-Ane C, Tronc F, Grima R, Baste JM, Thomas PA, Richard De Latour B, Pforr A, Pages PB. Medico-economic impact of thoracoscopy versus thoracotomy in lung cancer: multicentre randomised controlled trial (Lungsco01). BMC Health Serv Res. 2023 Sep 18;23(1):1004. doi: 10.1186/s12913-023-09962-y.
- Derived from this study: PubMed 28619764Pages PB, Abou Hanna H, Bertaux AC, Serge Aho LS, Magdaleinat P, Baste JM, Filaire M, de Latour R, Assouad J, Tronc F, Jayle C, Mouroux J, Thomas PA, Falcoz PE, Marty-Ane CH, Bernard A. Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01). BMJ Open. 2017 Jun 15;7(6):e012963. doi: 10.1136/bmjopen-2016-012963.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-thoracoscopy and thoracotomy in people with Lung Cancer and Lobectomy, run by Centre Hospitalier Universitaire Dijon at 10 sites 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 6 inclusion and 21 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: stopped early, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 was stopped early (reason given: lack of inclusions). Results are not available in the source record.
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?
The postoperative respiratory complications (time frame: 30 days after surgery). The study lists 2 primary outcomes in all. 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 NCT02502318, which also lists 2 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 12 Jan 2024.