Long-Term Quality of Life after Minimally Invasive vs Open Distal Pancreatectomy in the LEOPARD Randomized Trial

LEOPARD Trial Collaborators

doi:10.1016/j.jamcollsurg.2021.08.687

Long-Term Quality of Life after Minimally Invasive vs Open Distal Pancreatectomy in the LEOPARD Randomized Trial

LEOPARD Trial Collaborators

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

Background: Minimally invasive distal pancreatectomy (MIDP) shortens time to functional recovery and improves 30-day quality of life (QoL), as compared with open distal pancreatectomy (ODP) for nonmalignant disease. The impact of MIDP on QoL, cosmetic satisfaction, and overall major complications beyond 1-year follow-up is currently unknown.

Study Design: The Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD) trial randomized 108 patients to MIDP (laparoscopic or robotic) or ODP in 14 Dutch centers (April 2015 to March 2017). The primary outcome measure of this study was quality-adjusted life years (QALYs), as assessed with the EQ-5D. QoL was assessed using subscales of the EORTC QLQ-C30, PAN-26, and a body image questionnaire. The latter included a cosmetic satisfaction score (range 3–24), and a body image score (range 5–20). Differences between MIDP and ODP for QALYs, generic, and disease-specific QoL and body image were analyzed. Missing QoL data were imputed using multiple imputation.

Results: In total, 84 patients were alive, with a median follow-up of 44 months; 62 of these patients (74%) completed the questionnaires (27 MIDP, 35 ODP). There was no significant difference in QALYs between the 2 groups (mean score 2.34 vs 2.46 years, p = 0.63), nor on the QoL subscales. Significant overall change in EQ-5D health utilities were found for both groups over time (p < 0.001). Patients in the MIDP group scored higher on cosmetic satisfaction (21 vs 14, p = 0.049). No differences between the 2 groups were observed for clinical outcomes such as major complications, readmissions, and incisional hernias.

Conclusions: More than 3 years after distal pancreatectomy, no improvement in QALYs and overall QoL was seen after MIDP, whereas cosmetic satisfaction was higher after MIDP as compared with ODP.

Original language	English
Pages (from-to)	730-739.e9
Number of pages	19
Journal	Journal of the American College of Surgeons
Volume	233
Issue number	6
Early online date	13 Oct 2021
DOIs	https://doi.org/10.1016/j.jamcollsurg.2021.08.687
Publication status	Published - Dec 2021

Bibliographical note

Funding

We thank all investigators of the LEOPARD trial for their contributions. The LEOPARD trial collaborators are: H. C. van Santvoort (Department of Surgery, St Antonius Hospital, Nieuwegein, and University Medical Centre Utrecht, Utrecht, the Netherlands); M. T. de Boer (Department of Surgery, University Medical Centre Groningen, Groningen, the Netherlands); D. Boerma (Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands); P. B. van den Boezem (Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands); R. M. van Dam, C. H. Dejong (Department of Surgery, Maastricht University Medical Centre, Maastricht, the Netherlands, and Universitätsklinikum Aachen, Aachen, Germany); E. B. van Duyn (Department of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands); C. H. van Eijck (Department of Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands); M. F. Gerhards (Department of Surgery, OLVG, Amsterdam); I. H. de Hingh (Departments of Surgery, Catharina Hospital, Eindhoven, and Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands); G. Kazemier (Department of Surgery, Cancer Centre Amsterdam, Amsterdam UMC, VU University, Amsterdam, the Netherlands); R. H. de Kleine (Department of Surgery, University Medical Centre Groningen, Groningen, the Netherlands); C. J. van Laarhoven (Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands); G. A. Patijn, P. Steenvoorde (Department of Surgery, Isala Clinics, Zwolle, the Netherlands); M. Suker (Department of Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands); M. Abu Hilal (Department of General Surgery, Instituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy).

Funders
Maastricht University Medical Centre
Netherlands Comprehensive Cancer Organisation
Radboud University Medical Centre
University Medical Centre Utrecht
Universitätsklinikum Aachen
Department of Surgery

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@article{568d0304f717477c9394d76a98f35e70,

title = "Long-Term Quality of Life after Minimally Invasive vs Open Distal Pancreatectomy in the LEOPARD Randomized Trial",

abstract = "Background: Minimally invasive distal pancreatectomy (MIDP) shortens time to functional recovery and improves 30-day quality of life (QoL), as compared with open distal pancreatectomy (ODP) for nonmalignant disease. The impact of MIDP on QoL, cosmetic satisfaction, and overall major complications beyond 1-year follow-up is currently unknown. Study Design: The Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD) trial randomized 108 patients to MIDP (laparoscopic or robotic) or ODP in 14 Dutch centers (April 2015 to March 2017). The primary outcome measure of this study was quality-adjusted life years (QALYs), as assessed with the EQ-5D. QoL was assessed using subscales of the EORTC QLQ-C30, PAN-26, and a body image questionnaire. The latter included a cosmetic satisfaction score (range 3–24), and a body image score (range 5–20). Differences between MIDP and ODP for QALYs, generic, and disease-specific QoL and body image were analyzed. Missing QoL data were imputed using multiple imputation. Results: In total, 84 patients were alive, with a median follow-up of 44 months; 62 of these patients (74\%) completed the questionnaires (27 MIDP, 35 ODP). There was no significant difference in QALYs between the 2 groups (mean score 2.34 vs 2.46 years, p = 0.63), nor on the QoL subscales. Significant overall change in EQ-5D health utilities were found for both groups over time (p < 0.001). Patients in the MIDP group scored higher on cosmetic satisfaction (21 vs 14, p = 0.049). No differences between the 2 groups were observed for clinical outcomes such as major complications, readmissions, and incisional hernias. Conclusions: More than 3 years after distal pancreatectomy, no improvement in QALYs and overall QoL was seen after MIDP, whereas cosmetic satisfaction was higher after MIDP as compared with ODP.",

author = "M. Korrel and A. Roelofs and \{van Hilst\}, J. and O.R. Busch and F. Daams and S. Festen and \{Groot Koerkamp\}, B. and J. Klaase and M.D. Luyer and \{van Oijen\}, M.G. and \{Verdonck-de Leeuw\}, I.M. and M.G. Besselink and \{van Santvoort\}, H.C. and \{de Boer\}, M.T. and D. Boerma and \{van den Boezem\}, P.B. and \{van Dam\}, R.M. and C.H. Dejong and \{van Duyn\}, E.B. and \{van Eijck\}, C.H. and M.F. Gerhards and \{de Hingh\}, I.H. and G. Kazemier and \{de Kleine\}, R.H. and \{van Laarhoven\}, C.J. and G.A. Patijn and P. Steenvoorde and M. Suker and M.A. Hilal and \{LEOPARD Trial Collaborators\}",

note = "{\textcopyright} 2021 The Author(s).",

year = "2021",

month = dec,

doi = "10.1016/j.jamcollsurg.2021.08.687",

language = "English",

volume = "233",

pages = "730--739.e9",

journal = "Journal of the American College of Surgeons",

issn = "1072-7515",

publisher = "Lippincott Williams and Wilkins",

number = "6",

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TY - JOUR

T1 - Long-Term Quality of Life after Minimally Invasive vs Open Distal Pancreatectomy in the LEOPARD Randomized Trial

AU - Korrel, M.

AU - Roelofs, A.

AU - van Hilst, J.

AU - Busch, O.R.

AU - Daams, F.

AU - Festen, S.

AU - Groot Koerkamp, B.

AU - Klaase, J.

AU - Luyer, M.D.

AU - van Oijen, M.G.

AU - Verdonck-de Leeuw, I.M.

AU - Besselink, M.G.

AU - van Santvoort, H.C.

AU - de Boer, M.T.

AU - Boerma, D.

AU - van den Boezem, P.B.

AU - van Dam, R.M.

AU - Dejong, C.H.

AU - van Duyn, E.B.

AU - van Eijck, C.H.

AU - Gerhards, M.F.

AU - de Hingh, I.H.

AU - Kazemier, G.

AU - de Kleine, R.H.

AU - van Laarhoven, C.J.

AU - Patijn, G.A.

AU - Steenvoorde, P.

AU - Suker, M.

AU - Hilal, M.A.

AU - LEOPARD Trial Collaborators

PY - 2021/12

Y1 - 2021/12

N2 - Background: Minimally invasive distal pancreatectomy (MIDP) shortens time to functional recovery and improves 30-day quality of life (QoL), as compared with open distal pancreatectomy (ODP) for nonmalignant disease. The impact of MIDP on QoL, cosmetic satisfaction, and overall major complications beyond 1-year follow-up is currently unknown. Study Design: The Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD) trial randomized 108 patients to MIDP (laparoscopic or robotic) or ODP in 14 Dutch centers (April 2015 to March 2017). The primary outcome measure of this study was quality-adjusted life years (QALYs), as assessed with the EQ-5D. QoL was assessed using subscales of the EORTC QLQ-C30, PAN-26, and a body image questionnaire. The latter included a cosmetic satisfaction score (range 3–24), and a body image score (range 5–20). Differences between MIDP and ODP for QALYs, generic, and disease-specific QoL and body image were analyzed. Missing QoL data were imputed using multiple imputation. Results: In total, 84 patients were alive, with a median follow-up of 44 months; 62 of these patients (74%) completed the questionnaires (27 MIDP, 35 ODP). There was no significant difference in QALYs between the 2 groups (mean score 2.34 vs 2.46 years, p = 0.63), nor on the QoL subscales. Significant overall change in EQ-5D health utilities were found for both groups over time (p < 0.001). Patients in the MIDP group scored higher on cosmetic satisfaction (21 vs 14, p = 0.049). No differences between the 2 groups were observed for clinical outcomes such as major complications, readmissions, and incisional hernias. Conclusions: More than 3 years after distal pancreatectomy, no improvement in QALYs and overall QoL was seen after MIDP, whereas cosmetic satisfaction was higher after MIDP as compared with ODP.

AB - Background: Minimally invasive distal pancreatectomy (MIDP) shortens time to functional recovery and improves 30-day quality of life (QoL), as compared with open distal pancreatectomy (ODP) for nonmalignant disease. The impact of MIDP on QoL, cosmetic satisfaction, and overall major complications beyond 1-year follow-up is currently unknown. Study Design: The Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD) trial randomized 108 patients to MIDP (laparoscopic or robotic) or ODP in 14 Dutch centers (April 2015 to March 2017). The primary outcome measure of this study was quality-adjusted life years (QALYs), as assessed with the EQ-5D. QoL was assessed using subscales of the EORTC QLQ-C30, PAN-26, and a body image questionnaire. The latter included a cosmetic satisfaction score (range 3–24), and a body image score (range 5–20). Differences between MIDP and ODP for QALYs, generic, and disease-specific QoL and body image were analyzed. Missing QoL data were imputed using multiple imputation. Results: In total, 84 patients were alive, with a median follow-up of 44 months; 62 of these patients (74%) completed the questionnaires (27 MIDP, 35 ODP). There was no significant difference in QALYs between the 2 groups (mean score 2.34 vs 2.46 years, p = 0.63), nor on the QoL subscales. Significant overall change in EQ-5D health utilities were found for both groups over time (p < 0.001). Patients in the MIDP group scored higher on cosmetic satisfaction (21 vs 14, p = 0.049). No differences between the 2 groups were observed for clinical outcomes such as major complications, readmissions, and incisional hernias. Conclusions: More than 3 years after distal pancreatectomy, no improvement in QALYs and overall QoL was seen after MIDP, whereas cosmetic satisfaction was higher after MIDP as compared with ODP.

U2 - 10.1016/j.jamcollsurg.2021.08.687

DO - 10.1016/j.jamcollsurg.2021.08.687

M3 - Article

SN - 1072-7515

VL - 233

SP - 730-739.e9

JO - Journal of the American College of Surgeons

JF - Journal of the American College of Surgeons

IS - 6

ER -

Long-Term Quality of Life after Minimally Invasive vs Open Distal Pancreatectomy in the LEOPARD Randomized Trial

Abstract

Bibliographical note

Funding

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