Trials (Apr 2017)
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,
- for the Dutch Pancreatic Cancer Group
Affiliations
- Thijs de Rooij
- Department of Surgery, Academic Medical Center
- Jony van Hilst
- Department of Surgery, Academic Medical Center
- Jantien A. Vogel
- Department of Surgery, Academic Medical Center
- Hjalmar C. van Santvoort
- Department of Surgery, St Antonius Hospital
- Marieke T. de Boer
- Department of Surgery, University Medical Center Groningen
- Djamila Boerma
- Department of Surgery, St Antonius Hospital
- Peter B. van den Boezem
- Department of Surgery, Radboud University Nijmegen Medical Center
- Bert A. Bonsing
- Department of Surgery, Leiden University Medical Center
- Koop Bosscha
- Department of Surgery, Jeroen Bosch Hospital
- Peter-Paul Coene
- Department of Surgery, Maasstad Hospital
- Freek Daams
- Department of Surgery, VU University Medical Center
- Ronald M. van Dam
- Department of Surgery, Maastricht University Medical Center
- Marcel G. Dijkgraaf
- Clinical Research Unit, Academic Medical Center
- Casper H. van Eijck
- Department of Surgery, Erasmus University Medical Center
- Sebastiaan Festen
- Department of Surgery, Onze Lieve Vrouwe Gasthuis
- Michael F. Gerhards
- Department of Surgery, Onze Lieve Vrouwe Gasthuis
- Bas Groot Koerkamp
- Department of Surgery, Erasmus University Medical Center
- Jeroen Hagendoorn
- Department of Surgery, University Medical Center Utrecht
- Erwin van der Harst
- Department of Surgery, Maasstad Hospital
- Ignace H. de Hingh
- Department of Surgery, Catharina Hospital
- Cees H. Dejong
- Department of Surgery, Maastricht University Medical Center
- Geert Kazemier
- Department of Surgery, VU University Medical Center
- Joost Klaase
- Department of Surgery, Medisch Spectrum Twente
- Ruben H. de Kleine
- Department of Surgery, University Medical Center Groningen
- Cornelis J. van Laarhoven
- Department of Surgery, Radboud University Nijmegen Medical Center
- Daan J. Lips
- Department of Surgery, Jeroen Bosch Hospital
- Misha D. Luyer
- Department of Surgery, Catharina Hospital
- I. Quintus Molenaar
- Department of Surgery, University Medical Center Utrecht
- Vincent B. Nieuwenhuijs
- Department of Surgery, Isala Clinics
- Gijs A. Patijn
- Department of Surgery, Isala Clinics
- Daphne Roos
- Department of Surgery, Reinier de Graag Gasthuis
- Joris J. Scheepers
- Department of Surgery, Reinier de Graag Gasthuis
- George P. van der Schelling
- Department of Surgery, Amphia Hospital
- Pascal Steenvoorde
- Department of Surgery, Medisch Spectrum Twente
- Rutger-Jan Swijnenburg
- Department of Surgery, Leiden University Medical Center
- Jan H. Wijsman
- Department of Surgery, Amphia Hospital
- Moh’d Abu Hilal
- Department of Surgery, Southampton University Hospital NHS Foundation Trust
- Olivier R. Busch
- Department of Surgery, Academic Medical Center
- Marc G. Besselink
- Department of Surgery, Academic Medical Center
- for the Dutch Pancreatic Cancer Group
- DOI
- https://doi.org/10.1186/s13063-017-1892-9
- Journal volume & issue
-
Vol. 18,
no. 1
pp. 1 – 10
Abstract
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
Keywords
- Minimally invasive
- Laparoscopic
- Robot-assisted
- Distal pancreatectomy
- Pancreatic surgery
- Pancreatic cancer
