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2 results on '"Pierre Magdaleinat"'

1. Medico-economic impact of thoracoscopy versus thoracotomy in lung cancer: multicentre randomised controlled trial (Lungsco01)

Author

Anne-Laure Soilly, Ludwig Serge Aho Glélé, Alain Bernard, Halim Abou Hanna, Marc Filaire, Pierre Magdaleinat, Charles Marty-Ané, François Tronc, Renaud Grima, Jean-Marc Baste, Pascal-Alexandre Thomas, Bertrand Richard De Latour, Arnaud Pforr, and Pierre-Benoît Pagès

Subjects
Cost analysis, Cost-utility analysis, Thoracoscopy, Thoracotomy, Lung cancer surgery, Public aspects of medicine, RA1-1270
Abstract

Abstract Background Lungsco01 is the first study assessing the real benefits and the medico-economic impact of video-thoracoscopy versus open thoracotomy for non-small cell lung cancer in the French context. Methods Two hundred and fifty nine adult patients from 10 French centres were randomised in this prospective multicentre randomised controlled trial, between July 29, 2016, and November 24, 2020. Survival from surgical intervention to day 30 and later was compared with the log-rank test. Total quality-adjusted-life-years (QALYs) were calculated using the EQ-5D-3L®. For medico-economic analyses at 30 days and at 3 months after surgery, resources consumed were valorised (€ 2018) from a hospital perspective. First, since mortality was infrequent and not different between the two arms, cost-minimisation analyses were performed considering only the cost differential. Second, based on complete cases on QALYs, cost-utility analyses were performed taking into account cost and QALY differential. Acceptability curves and the 95% confidence intervals for the incremental ratios were then obtained using the non-parametric bootstrap method (10,000 replications). Sensitivity analyses were performed using multiple imputations with the chained equation method. Results The average cumulative costs of thoracotomy were lower than those of video-thoracoscopy at 30 days (€9,730 (SD = 3,597) vs. €11,290 (SD = 4,729)) and at 3 months (€9,863 (SD = 3,508) vs. €11,912 (SD = 5,159)). In the cost-utility analyses, the incremental cost-utility ratio was €19,162 per additional QALY gained at 30 days (€36,733 at 3 months). The acceptability curve revealed a 64% probability of efficiency at 30 days for video-thoracoscopy, at a widely-accepted willingness-to-pay threshold of €25,000 (34% at 3 months). Ratios increased after multiple imputations, implying a higher cost for video-thoracoscopy for an additional QALY gain (ratios: €26,015 at 30 days, €42,779 at 3 months). Conclusions Given our results, the economic efficiency of video-thoracoscopy at 30 days remains fragile at a willingness-to-pay threshold of €25,000/QALY. The economic efficiency is not established beyond that time horizon. The acceptability curves given will allow decision-makers to judge the probability of efficiency of this technology at other willingness-to-pay thresholds. Trial registration NCT02502318.

Published
2023
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2. Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01)

Author

Halim Abou Hanna, Charles-Henri Marty-Ané, Pierre-Emmanuel Falcoz, Alain Bernard, Pascal-Alexandre Thomas, Jalal Assouad, Christophe Jayle, Pierre-Benoit Pagès, Ludwig Serge Serge Aho, Jean-Marc Baste, Anne-Claire Bertaux, Jérome Mouroux, François Tronc, Marc Filaire, Richard de Latour, Pierre Magdaleinat, Service de chirurgie cardio-vasculaire et thoracique (CHU Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Service d'épidémiologie et d'hygiène hospitalières (CHU de Dijon), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de chirurgie générale et thoracique [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Département de chirurgie thoracique (Centre Centre Jean Perrin, Clermont-Ferrand), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER-UNICANCER, Service de chirurgie thoracique cardiaque et vasculaire [Rennes] = Thoracic and Cardiovascular Surgery [Rennes], CHU Pontchaillou [Rennes], CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de chirurgie thoracique (HCL, Hôpital Louis Pradel, Bron), Hospices Civils de Lyon (HCL)-Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL), Service de chirurgie cardio-vasculaire et thoracique (CHU de Poitiers), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Service de Chirurgie thoracique, Centre Hospitalier Universitaire de Nice (CHU Nice), Departement de chirurgie thoracique et des maladies de l'oesophage [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Dpt chirurgie thoracique [CHU Strasbourg], CHU Strasbourg, Département Chirurgie cardiaque, thoracique et vasculaire (CHU de Montpellier), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de chirurgie thoracique cardiaque et vasculaire [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Service de chirurgie thoracique [CHU Tenon], Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Nord [CHU - APHM]-Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP], and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)

Subjects
Male, medicine.medical_treatment, Cost-Benefit Analysis, 030204 cardiovascular system & hematology, law.invention, 0302 clinical medicine, Postoperative Complications, Randomized controlled trial, Statistics and research methods, law, Carcinoma, Non-Small-Cell Lung, Protocol, Thoracotomy, Pneumonectomy, medicine.diagnostic_test, Thoracic Surgery, Video-Assisted, General Medicine, 3. Good health, Treatment Outcome, Cardiothoracic surgery, Female, Non small cell, France, Adult, medicine.medical_specialty, VATS lobectomy, Operative Time, Respiratory tract tumours, [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery, STATISTICS & RESEARCH METHODS, 03 medical and health sciences, medicine, Thoracoscopy, Humans, Lung cancer, Retrospective Studies, Protocol (science), business.industry, Reproducibility of Results, Length of Stay, medicine.disease, Survival Analysis, Surgery, 030228 respiratory system, business, Health economics
Abstract

IF 2.562; International audience; Introduction In the last decade, video-assisted thoracoscopic surgery (VATS) lobectomy for non-small cell lung cancer (NSCLC) has had a major effect on thoracic surgery. Retrospective series have reported benefits of VATS when compared with open thoracotomy in terms of postoperative pain, postoperative complications and length of hospital stay. However, no large randomised control trial has been conducted to assess the reality of the potential benefits of VATS lobectomy or its medicoeconomic impact.Methods and analysis The French National Institute of Health funded Lungsco01 to determine whether VATS for lobectomy is superior to open thoracotomy for the treatment of NSCLC in terms of economic cost to society. This trial will also include an analysis of postoperative outcomes, the length of hospital stay, the quality of life, long-term survival and locoregional recurrence. The study design is a two-arm parallel randomised controlled trial comparing VATS lobectomy with lobectomy using thoracotomy for the treatment of NSCLC. Patients will be eligible if they have proven or suspected lung cancer which could be treated by lobectomy. Patients will be randomised via an independent service. All patients will be monitored according to standard thoracic surgical practices. All patients will be evaluated at day 1, day 30, month 3, month 6, month 12 and then every year for 2 years thereafter. The recruitment target is 600 patients.Ethics and dissemination The protocol has been approved by the French National Research Ethics Committee (CPP Est I: 09/06/2015) and the French Medicines Agency (09/06/2015). Results will be presented at national and international meetings and conferences and published in peer-reviewed journals.Trial registration number NCT02502318.

Published
2017
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