TY - JOUR
T1 - Minimally invasive versus open distal pancreatectomy (LEOPARD)
T2 - Study protocol for a randomized controlled trial
AU - de Rooij, Thijs
AU - van Hilst, Jony
AU - Vogel, Jantien A.
AU - van Santvoort, Hjalmar C.
AU - de Boer, Marieke T.
AU - Boerma, Djamila
AU - van den Boezem, Peter B.
AU - Bonsing, Bert A.
AU - Bosscha, Koop
AU - Coene, Peter Paul
AU - Daams, Freek
AU - van Dam, Ronald M.
AU - Dijkgraaf, Marcel G.
AU - van Eijck, Casper H.
AU - Festen, Sebastiaan
AU - Gerhards, Michael F.
AU - Groot Koerkamp, Bas
AU - Hagendoorn, Jeroen
AU - van der Harst, Erwin
AU - de Hingh, Ignace H.
AU - Dejong, Cees H.
AU - Kazemier, Geert
AU - Klaase, Joost
AU - de Kleine, Ruben H.
AU - van Laarhoven, Cornelis J.
AU - Lips, Daan J.
AU - Luyer, Misha D.
AU - Molenaar, I. Quintus
AU - Nieuwenhuijs, Vincent B.
AU - Patijn, Gijs A.
AU - Roos, Daphne
AU - Scheepers, Joris J.
AU - van der Schelling, George P.
AU - Steenvoorde, Pascal
AU - Swijnenburg, Rutger Jan
AU - Wijsman, Jan H.
AU - Abu Hilal, Moh'd
AU - Busch, Olivier R.
AU - Besselink, Marc G.
AU - for the Dutch Pancreatic Cancer Group
PY - 2017/4/8
Y1 - 2017/4/8
N2 - 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
AB - 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
KW - Distal pancreatectomy
KW - Laparoscopic
KW - Minimally invasive
KW - Pancreatic cancer
KW - Pancreatic surgery
KW - Robot-assisted
UR - http://www.scopus.com/inward/record.url?scp=85018479860&partnerID=8YFLogxK
U2 - 10.1186/s13063-017-1892-9
DO - 10.1186/s13063-017-1892-9
M3 - Article
C2 - 28388963
AN - SCOPUS:85018479860
VL - 18
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 166
ER -