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

Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial.
Author Information (click to view)

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 PP, Daams F, van Dam RM, Dijkgraaf MG, van Eijck CH, Festen S, Gerhards MF, Groot Koerkamp B, 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 RJ, Wijsman JH, Abu Hilal M, Busch OR, Besselink MG, ,


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 PP, Daams F, van Dam RM, Dijkgraaf MG, van Eijck CH, Festen S, Gerhards MF, Groot Koerkamp B, 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 RJ, Wijsman JH, Abu Hilal M, Busch OR, Besselink MG, , (click to view)

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 PP, Daams F, van Dam RM, Dijkgraaf MG, van Eijck CH, Festen S, Gerhards MF, Groot Koerkamp B, 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 RJ, Wijsman JH, Abu Hilal M, Busch OR, Besselink MG, ,

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Trials 2017 04 0818(1) 166 doi 10.1186/s13063-017-1892-9
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.

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