TerminatedNot Applicable

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

Stopped: lack of inclusions

France261 participantsStarted 2015-07-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * Patie…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The postoperative respiratory complications

Timeframe: 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

Timeframe: 3 months after surgery

Trial details

NCT IDNCT02502318

SponsorCentre Hospitalier Universitaire Dijon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-08

View on ClinicalTrials.gov More Lung Cancer trials