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Medicoeconomic Evaluation of Two Surgical Techniques for Lobectomy in the Lung Cancer (LungSco01)

Primary Purpose

Lung Cancer, Lobectomy

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Video-thoracoscopy
thoracotomy
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer focused on measuring Proven or suspected lung cancer treated by lobectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who have given their consent
  • Any patient with proven or suspected lung cancer treated by lobectomy.
  • Patients with a negative mediastinoscopy or negative " EBUS-EUS " following a PET scan showing uptake in mediastinal lymph nodes in the preoperative examination.
  • Age between 18 and 80 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).

Sites / Locations

  • CHU Amiens
  • CH Victor Dupouy
  • CH Avignon
  • Centre Jean Perrin - Clermont-Ferrand
  • CHU Dijon
  • HCL - Louis Pradel
  • APHM Hôpital Nord
  • CHU de Montpellier
  • CHU de Nice - Hôpital Pasteur
  • APHP Hôpital Cochin
  • APHP Hôpital de Tenon
  • CHU de Poitiers
  • CHU de Rennes - Hôpital de Pontchaillou
  • CHU de Rouen
  • HUS Strasbourg - Nouvel Hôpital Civil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lobectomy or segmentectomy using video-thoracoscopy

Lobectomy or segmentectomy using thoracotomy

Arm Description

Outcomes

Primary Outcome Measures

The postoperative respiratory complications
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

Secondary Outcome Measures

Full Information

First Posted
July 15, 2015
Last Updated
December 8, 2022
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT02502318
Brief Title
Medicoeconomic Evaluation of Two Surgical Techniques for Lobectomy in the Lung Cancer
Acronym
LungSco01
Official Title
Medicoeconomic Analysis of Lobectomy Using Thoracoscopy vs Thoracotomy for Lung Cancer: a Multicentric Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
lack of inclusions
Study Start Date
July 29, 2015 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lobectomy
Keywords
Proven or suspected lung cancer treated by lobectomy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lobectomy or segmentectomy using video-thoracoscopy
Arm Type
Experimental
Arm Title
Lobectomy or segmentectomy using thoracotomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Video-thoracoscopy
Intervention Type
Procedure
Intervention Name(s)
thoracotomy
Primary Outcome Measure Information:
Title
The postoperative respiratory complications
Time Frame
30 days after surgery
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
CH Victor Dupouy
City
Argenteuil
Country
France
Facility Name
CH Avignon
City
Avignon
Country
France
Facility Name
Centre Jean Perrin - Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
HCL - Louis Pradel
City
Lyon
Country
France
Facility Name
APHM Hôpital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nice - Hôpital Pasteur
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
APHP Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
APHP Hôpital de Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU de Rennes - Hôpital de Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
HUS Strasbourg - Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28619764
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.
Results Reference
derived

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

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