Costs and quality of life in a randomized trial comparing minimally invasive and open distal pancreatectomy (LEOPARD trial)

Author:

van Hilst J1,Strating E A1,de Rooij T1,Daams F2,Festen S3,Groot Koerkamp B4ORCID,Klaase J M5,Luyer M6,Dijkgraaf M G7,Besselink M G1ORCID,van Santvoort H C8,de Boer M T9,Boerma D10,van den Boezem P B11,van Dam R M1213,Dejong C H1213,van Duyn E B14,van Eijck C H15,Gerhards M F16,de Hingh I H17,Kazemier G18,de Kleine R H9,van Laarhoven C J11,Patijn G A19,Steenvoorde P19,Suker M15,Hilal M Abu20

Affiliation:

1. Department of Surgery, Cancer Center Amsterdam, Amsterdam, The Netherlands

2. Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, VU University, Amsterdam, The Netherlands

3. Department of Surgery, OLVG, Amsterdam, The Netherlands

4. Department of Surgery, Erasmus MC, Rotterdam, The Netherlands

5. Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands

6. Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands

7. Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands

8. Department of Surgery, St Antonius Hospital, Nieuwegein, and University Medical Centre Utrecht, Utrecht, the Netherlands

9. Department of Surgery, University Medical Centre Groningen, Groningen, the Netherlands

10. Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands

11. Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands

12. Department of Surgery, Maastricht University Medical Centre, Maastricht, the Netherlands

13. Universitätsklinikum Aachen, Aachen, Germany

14. Department of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands

15. Department of Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands

16. Department of Surgery, OLVG, Amsterdam

17. Departments of Surgery, Catharina Hospital, Eindhoven, Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands

18. Department of Surgery, Cancer Centre Amsterdam, Amsterdam UMC, VU University, Amsterdam, the Netherlands

19. Department of Surgery, Isala Clinics, Zwolle, the Netherlands

20. Department of Surgery, Southampton University Medical Centre NHS Foundation Trust, Southampton, UK

Abstract

Abstract Background Minimally invasive distal pancreatectomy decreases time to functional recovery compared with open distal pancreatectomy, but the cost-effectiveness and impact on disease-specific quality of life have yet to be established. Methods The LEOPARD trial randomized patients to minimally invasive (robot-assisted or laparoscopic) or open distal pancreatectomy in 14 Dutch centres between April 2015 and March 2017. Use of hospital healthcare resources, complications and disease-specific quality of life were recorded up to 1 year after surgery. Unit costs of hospital healthcare resources were determined, and cost-effectiveness and cost–utility analyses were performed. Primary outcomes were the costs per day earlier functional recovery and per quality-adjusted life-year. Results All 104 patients who had a distal pancreatectomy (48 minimally invasive and 56 open) in the trial were included in this study. Patients who underwent a robot-assisted procedure were excluded from the cost analysis. Total medical costs were comparable after laparoscopic and open distal pancreatectomy (mean difference €–427 (95 per cent bias-corrected and accelerated confidence interval €–4700 to 3613; P = 0·839). Laparoscopic distal pancreatectomy was shown to have a probability of at least 0·566 of being more cost-effective than the open approach at a willingness-to-pay threshold of €0 per day of earlier recovery, and a probability of 0·676 per additional quality-adjusted life-year at a willingness-to-pay threshold of €80 000. There were no significant differences in cosmetic satisfaction scores (median 9 (i.q.r. 5·75–10) versus 7 (4–8·75); P = 0·056) and disease-specific quality of life after minimally invasive (laparoscopic and robot-assisted procedures) versus open distal pancreatectomy. Conclusion Laparoscopic distal pancreatectomy was at least as cost-effective as open distal pancreatectomy in terms of time to functional recovery and quality-adjusted life-years. Cosmesis and quality of life were similar in the two groups 1 year after surgery.

Funder

Ethicon

Publisher

Oxford University Press (OUP)

Subject

Surgery

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