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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: 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, for the Dutch Pancreatic Cancer Group

Published in: Trials | Issue 1/2017

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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.

Trial registration

Dutch Trial Register, NTR5188. Registered on 9 April 2015
Appendix
Available only for authorised users
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Metadata
Title
Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial
Authors
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
for the Dutch Pancreatic Cancer Group
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1892-9

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