Clinical trial NCT02502318: Medicoeconomic Evaluation of Two Surgical Techniques for Lobectomy in the Lung Cancer
Official title: Medicoeconomic Analysis of Lobectomy Using Thoracoscopy vs Thoracotomy for Lung Cancer: a Multicentric Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Lobectomy
Keywords: Proven or suspected lung cancer treated by lobectomy
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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).

Primary outcomes:
measure: The postoperative respiratory complications
timeFrame: 30 days after surgery
measure: 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
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: Avignon
country: France
facility: CH Avignon
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin - Clermont-Ferrand
city: Dijon
country: France
facility: CHU Dijon
city: Lyon
country: France
facility: HCL - Louis Pradel
city: Marseille
country: France
facility: APHM Hôpital Nord
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: APHP Hôpital Cochin
city: Rennes
country: France
facility: CHU de Rennes - Hôpital de Pontchaillou
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
References:
citation: Pages 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.