Medicoeconomic Evaluation of Two Surgical Techniques for Lobectomy in the Lung Cancer

Lung Cancer Clinical Trial

— LungSco01  

Official title:

Medicoeconomic Analysis of Lobectomy Using Thoracoscopy vs Thoracotomy for Lung Cancer: a Multicentric Randomized Controlled Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02502318
• Other study ID #: BERNARD PRME 2014
• Status: Terminated
• Phase: N/A
• Start date: July 29, 2015
• Est. completion date: October 8, 2021

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 261
• Est. completion date: October 8, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lobectomy
• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Video-thoracoscopy

• thoracotomy

Locations

Country	Name	City	State
France	CH Victor Dupouy	Argenteuil
France	CH Avignon	Avignon
France	Centre Jean Perrin - Clermont-Ferrand	Clermont-Ferrand
France	CHU Dijon	Dijon
France	HCL - Louis Pradel	Lyon
France	APHM Hôpital Nord	Marseille
France	CHU de Montpellier	Montpellier
France	APHP Hôpital Cochin	Paris
France	CHU de Rennes - Hôpital de Pontchaillou	Rennes
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The postoperative respiratory complications		30 days after surgery
Primary	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		3 months after surgery