Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial

Thijs de Rooij; Jony van Hilst; Jantien A. Vogel; Hjalmar C. van Santvoort; Marieke T. de Boer; Djamila Boerma; Peter B. van den Boezem; Bert A. Bonsing; Koop Bosscha; Peter-Paul Coene; Freek Daams; Ronald M. van Dam; Marcel G. Dijkgraaf; Casper H. van Eijck; Sebastiaan Festen; Michael F. Gerhards; Bas Groot Koerkamp; Jeroen Hagendoorn; Erwin van der Harst; Ignace H. de Hingh; Cees H. Dejong; Geert Kazemier; Joost Klaase; Ruben H. de Kleine; Cornelis J. van Laarhoven; Daan J. Lips; Misha D. Luyer; I. Quintus Molenaar; Vincent B. Nieuwenhuijs; Gijs A. Patijn; Daphne Roos; Joris J. Scheepers; George P. van der Schelling; Pascal Steenvoorde; Rutger-Jan Swijnenburg; Jan H. Wijsman; Moh'd Abu Hilal; Olivier R. Busch; Marc G. Besselink; Dutch Pancreatic Canc Grp

doi:10.1186/s13063-017-1892-9

Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial

Thijs de Rooij, Jony van Hilst, Jantien A. Vogel, Hjalmar C. van Santvoort, Marieke T. de Boer, Djamila Boerma, Peter B. van den Boezem, Bert A. Bonsing, Koop Bosscha, Peter-Paul Coene, Freek Daams, Ronald M. van Dam, Marcel G. Dijkgraaf, Casper H. van Eijck, Sebastiaan Festen, Michael F. Gerhards, Bas Groot Koerkamp, Jeroen Hagendoorn, Erwin van der Harst, Ignace H. de HinghCees H. Dejong, Geert Kazemier, Joost Klaase, Ruben H. de Kleine, Cornelis J. van Laarhoven, Daan J. Lips, Misha D. Luyer, I. Quintus Molenaar, Vincent B. Nieuwenhuijs, Gijs A. Patijn, Daphne Roos, Joris J. Scheepers, George P. van der Schelling, Pascal Steenvoorde, Rutger-Jan Swijnenburg, Jan H. Wijsman, Moh'd Abu Hilal, Olivier R. Busch, Marc G. Besselink^*, Dutch Pancreatic Canc Grp

^*Corresponding author for this work

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

Abstract

Background: Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting.

Methods: LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs.

Discussion: The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting.

Original language	English
Article number	166
Number of pages	10
Journal	Trials
Volume	18
DOIs	https://doi.org/10.1186/s13063-017-1892-9
Publication status	Published - 8 Apr 2017

Keywords

Minimally invasive
Laparoscopic
Robot-assisted
Distal pancreatectomy
Pancreatic surgery
Pancreatic cancer
INTERNATIONAL STUDY-GROUP
DUCTAL ADENOCARCINOMA
IDEAL FRAMEWORK
SURGERY ISGPS
LONG-TERM
MALIGNANT-DISEASE
CLINICAL-TRIAL
DEFINITION
PANCREATOSPLENECTOMY
BENIGN

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Cite this

de Rooij, T., van Hilst, J., Vogel, J. A., van Santvoort, H. C., de Boer, M. T., Boerma, D., van den Boezem, P. B., Bonsing, B. A., Bosscha, K., Coene, P.-P., Daams, F., van Dam, R. M., Dijkgraaf, M. G., van Eijck, C. H., Festen, S., Gerhards, M. F., Koerkamp, B. G., Hagendoorn, J., van der Harst, E., ... Dutch Pancreatic Canc Grp (2017). Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial. Trials, 18, Article 166. https://doi.org/10.1186/s13063-017-1892-9

@article{fad0b078f2074c878890132acb97598d,

title = "Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial",

abstract = "Background: Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting.Methods: LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs.Discussion: The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting.",

keywords = "Minimally invasive, Laparoscopic, Robot-assisted, Distal pancreatectomy, Pancreatic surgery, Pancreatic cancer, INTERNATIONAL STUDY-GROUP, DUCTAL ADENOCARCINOMA, IDEAL FRAMEWORK, SURGERY ISGPS, LONG-TERM, MALIGNANT-DISEASE, CLINICAL-TRIAL, DEFINITION, PANCREATOSPLENECTOMY, BENIGN",

author = "{de Rooij}, Thijs and {van Hilst}, Jony and Vogel, {Jantien A.} and {van Santvoort}, {Hjalmar C.} and {de Boer}, {Marieke T.} and Djamila Boerma and {van den Boezem}, {Peter B.} and Bonsing, {Bert A.} and Koop Bosscha and Peter-Paul Coene and Freek Daams and {van Dam}, {Ronald M.} and Dijkgraaf, {Marcel G.} and {van Eijck}, {Casper H.} and Sebastiaan Festen and Gerhards, {Michael F.} and Koerkamp, {Bas Groot} and Jeroen Hagendoorn and {van der Harst}, Erwin and {de Hingh}, {Ignace H.} and Dejong, {Cees H.} and Geert Kazemier and Joost Klaase and {de Kleine}, {Ruben H.} and {van Laarhoven}, {Cornelis J.} and Lips, {Daan J.} and Luyer, {Misha D.} and Molenaar, {I. Quintus} and Nieuwenhuijs, {Vincent B.} and Patijn, {Gijs A.} and Daphne Roos and Scheepers, {Joris J.} and {van der Schelling}, {George P.} and Pascal Steenvoorde and Rutger-Jan Swijnenburg and Wijsman, {Jan H.} and {Abu Hilal}, Moh'd and Busch, {Olivier R.} and Besselink, {Marc G.} and {Dutch Pancreatic Canc Grp}",

year = "2017",

month = apr,

day = "8",

doi = "10.1186/s13063-017-1892-9",

language = "English",

volume = "18",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd",

}

de Rooij, T, van Hilst, J, Vogel, JA, van Santvoort, HC, de Boer, MT, Boerma, D, van den Boezem, PB, Bonsing, BA, Bosscha, K, Coene, P-P, Daams, F, van Dam, RM, Dijkgraaf, MG, van Eijck, CH, Festen, S, Gerhards, MF, Koerkamp, BG, Hagendoorn, J, van der Harst, E, de Hingh, IH, Dejong, CH, Kazemier, G, Klaase, J, de Kleine, RH, van Laarhoven, CJ, Lips, DJ, Luyer, MD, Molenaar, IQ, Nieuwenhuijs, VB, Patijn, GA, Roos, D, Scheepers, JJ, van der Schelling, GP, Steenvoorde, P, Swijnenburg, R-J, Wijsman, JH, Abu Hilal, M, Busch, OR, Besselink, MG & Dutch Pancreatic Canc Grp 2017, 'Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial', Trials, vol. 18, 166. https://doi.org/10.1186/s13063-017-1892-9

TY - JOUR

T1 - Minimally invasive versus open distal pancreatectomy (LEOPARD)

T2 - study protocol for a randomized controlled trial

AU - de Rooij, Thijs

AU - van Hilst, Jony

AU - Vogel, Jantien A.

AU - van Santvoort, Hjalmar C.

AU - de Boer, Marieke T.

AU - Boerma, Djamila

AU - van den Boezem, Peter B.

AU - Bonsing, Bert A.

AU - Bosscha, Koop

AU - Coene, Peter-Paul

AU - Daams, Freek

AU - van Dam, Ronald M.

AU - Dijkgraaf, Marcel G.

AU - van Eijck, Casper H.

AU - Festen, Sebastiaan

AU - Gerhards, Michael F.

AU - Koerkamp, Bas Groot

AU - Hagendoorn, Jeroen

AU - van der Harst, Erwin

AU - de Hingh, Ignace H.

AU - Dejong, Cees H.

AU - Kazemier, Geert

AU - Klaase, Joost

AU - de Kleine, Ruben H.

AU - van Laarhoven, Cornelis J.

AU - Lips, Daan J.

AU - Luyer, Misha D.

AU - Molenaar, I. Quintus

AU - Nieuwenhuijs, Vincent B.

AU - Patijn, Gijs A.

AU - Roos, Daphne

AU - Scheepers, Joris J.

AU - van der Schelling, George P.

AU - Steenvoorde, Pascal

AU - Swijnenburg, Rutger-Jan

AU - Wijsman, Jan H.

AU - Abu Hilal, Moh'd

AU - Busch, Olivier R.

AU - Besselink, Marc G.

AU - Dutch Pancreatic Canc Grp

PY - 2017/4/8

Y1 - 2017/4/8

N2 - Background: Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting.Methods: LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs.Discussion: The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting.

AB - Background: Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting.Methods: LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs.Discussion: The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting.

KW - Minimally invasive

KW - Laparoscopic

KW - Robot-assisted

KW - Distal pancreatectomy

KW - Pancreatic surgery

KW - Pancreatic cancer

KW - INTERNATIONAL STUDY-GROUP

KW - DUCTAL ADENOCARCINOMA

KW - IDEAL FRAMEWORK

KW - SURGERY ISGPS

KW - LONG-TERM

KW - MALIGNANT-DISEASE

KW - CLINICAL-TRIAL

KW - DEFINITION

KW - PANCREATOSPLENECTOMY

KW - BENIGN

U2 - 10.1186/s13063-017-1892-9

DO - 10.1186/s13063-017-1892-9

M3 - Article

C2 - 28388963

SN - 1745-6215

VL - 18

JO - Trials

JF - Trials

M1 - 166

ER -