NCT02502318

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

July 29, 2015

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

6.2 years

First QC Date

July 15, 2015

Last Update Submit

January 11, 2024

Conditions

Lung CancerLobectomy

Keywords

Proven or suspected lung cancer treated by lobectomy

Outcome Measures

Primary Outcomes (2)

  • The postoperative respiratory complications

    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

    3 months after surgery

Study Arms (2)

Lobectomy or segmentectomy using video-thoracoscopy

EXPERIMENTAL
Procedure: Video-thoracoscopy

Lobectomy or segmentectomy using thoracotomy

ACTIVE COMPARATOR
Procedure: thoracotomy

Interventions

Video-thoracoscopyPROCEDURE
Lobectomy or segmentectomy using video-thoracoscopy
thoracotomyPROCEDURE
Lobectomy or segmentectomy using thoracotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CH Victor Dupouy

Argenteuil, France

Location

CH Avignon

Avignon, France

Location

Centre Jean Perrin - Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU Dijon

Dijon, 21079, France

Location

HCL - Louis Pradel

Lyon, France

Location

APHM Hôpital Nord

Marseille, 13015, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

APHP Hôpital Cochin

Paris, 75014, France

Location

CHU de Rennes - Hôpital de Pontchaillou

Rennes, 35000, France

Location

CHU de Rouen

Rouen, 76031, France

Location

Related Publications (2)

  • 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.

    PMID: 37723516DERIVED

  • 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.

    PMID: 28619764DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Thoracotomy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thoracic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 20, 2015

Study Start

July 29, 2015

Primary Completion

October 8, 2021

Study Completion

October 8, 2021

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations

FR(10)