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TerminatedNCT02502318LungSco01Updated Jan 12, 2024

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

An interventional study of Video-thoracoscopy and thoracotomy in Lung Cancer and Lobectomy, sponsored by Centre Hospitalier Universitaire Dijon. Terminated at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-12.

Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Other

Why this study was terminated
lack of inclusions
Phase
Not applicable
Study type
Interventional
Enrollment
261
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Lung Cancer
  • Lobectomy

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Keywords

  • Proven or suspected lung cancer treated by lobectomy
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 261 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
261 participants (actual)

Study arms

  • Experimental
    Lobectomy or segmentectomy using video-thoracoscopy

    Procedure: Video-thoracoscopy

  • Active comparator
    Lobectomy or segmentectomy using thoracotomy

    Procedure: thoracotomy

Interventions

  • ProcedureVideo-thoracoscopy
  • Procedurethoracotomy
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What researchers measure

Primary outcomes

  1. The postoperative respiratory complications

    Time frame: 30 days after surgery

  2. 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

07

Study locations

10 sites
  • CH Victor Dupouy
    Argenteuil, France
  • CH Avignon
    Avignon, France
  • Centre Jean Perrin - Clermont-Ferrand
    Clermont-Ferrand, 63000, France
  • CHU Dijon
    Dijon, 21079, France
  • HCL - Louis Pradel
    Lyon, France
  • APHM Hôpital Nord
    Marseille, 13015, France
  • CHU de Montpellier
    Montpellier, 34295, France
  • APHP Hôpital Cochin
    Paris, 75014, France
  • CHU de Rennes - Hôpital de Pontchaillou
    Rennes, 35000, France
  • CHU de Rouen
    Rouen, 76031, France
08

References and documents

Publications

  • 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. PubMed 28619764 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02502318
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Jul 20, 2015
Start date
Jul 29, 2015
Primary completion
Oct 8, 2021
Completion
Oct 8, 2021
Last update
Jan 12, 2024
View the source record on ClinicalTrials.gov ↗

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