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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

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

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
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
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1892-9) contains supplementary material, which is available to authorized users.

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
Zusatzmaterial
Additional file 1: SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 112 kb)
13063_2017_1892_MOESM1_ESM.doc
Literatur
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