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


ABSTRACT: 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.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.The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting.Dutch Trial Register, NTR5188 . Registered on 9 April 2015.

SUBMITTER: de Rooij T 

PROVIDER: S-EPMC5385082 | biostudies-other | 2017 Apr

REPOSITORIES: biostudies-other

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

de Rooij Thijs T   van Hilst Jony J   Vogel Jantien A JA   van Santvoort Hjalmar C HC   de Boer Marieke T MT   Boerma Djamila D   van den Boezem Peter B PB   Bonsing Bert A BA   Bosscha Koop K   Coene Peter-Paul PP   Daams Freek F   van Dam Ronald M RM   Dijkgraaf Marcel G MG   van Eijck Casper H CH   Festen Sebastiaan S   Gerhards Michael F MF   Groot Koerkamp Bas B   Hagendoorn Jeroen J   van der Harst Erwin E   de Hingh Ignace H IH   Dejong Cees H CH   Kazemier Geert G   Klaase Joost J   de Kleine Ruben H RH   van Laarhoven Cornelis J CJ   Lips Daan J DJ   Luyer Misha D MD   Molenaar I Quintus IQ   Nieuwenhuijs Vincent B VB   Patijn Gijs A GA   Roos Daphne D   Scheepers Joris J JJ   van der Schelling George P GP   Steenvoorde Pascal P   Swijnenburg Rutger-Jan RJ   Wijsman Jan H JH   Abu Hilal Moh'd M   Busch Olivier R OR   Besselink Marc G MG  

Trials 20170408 1


<h4>Background</h4>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 mult  ...[more]

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