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

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 r... Mehr ...

Verfasser: de Rooij, Thijs
van Hilst, Jony
Vogel, Jantien A
van Santvoort, Hjalmar C
de Boer, Marieke T.
Boerma, Djamila
van den Boezem, Peter B.
Bonsing, Bert A.
Bosscha, Koop
Coene, Peter-Paul
Daams, Freek
van Dam, Ronald M.
Dijkgraaf, Marcel G. W.
van Eijck, Casper H.
Festen, Sebastiaan
Gerhards, Michael F.
Groot Koerkamp, Bas
Hagendoorn, Jeroen
van der Harst, Erwin
de Hingh, Ignace H.
Dejong, Cees H.
Kazemier, Geert
Klaase, Joost M.
de Kleine, Ruben H J
van Laarhoven, Cornelis J.
Lips, Daan J.
Luyer, Misha Dp
Molenaar, I Quintus
Nieuwenhuijs, Vincent B.
Patijn, Gijs A.
Roos, Daphne
Scheepers, Joris Jg
Van Der Schelling, George P.
Steenvoorde, Pascal
Swijnenburg, Rutger-Jan
Wijsman, Jan H
Abu Hilal, Moh'd
Busch, Olivier R C
Besselink, Marc G H
Dutch Pancreatic Cancer Group
Dokumenttyp: Artikel
Erscheinungsdatum: 2017
Schlagwörter: Minimally invasive / Laparoscopic / Robot-assisted / Distal pancreatectomy / Pancreatic surgery / Pancreatic cancer / Hospital Costs / Humans / Clinical Protocols / Recovery of Function / Pain / Postoperative/etiology / Netherlands / Analgesics/administration & dosage / Time Factors / Robotic Surgical Procedures/adverse effects / Eating / Administration / Oral / Treatment Outcome / Energy Intake / Pancreatectomy/adverse effects / Cost-Benefit Analysis / Laparoscopy/adverse effects / Quality of Life / Health Status / Pain Measurement / Research Design / Pharmacology (medical) / Medicine (miscellaneous) / Journal Article / Research Support / Non-U.S. Gov't / Randomized Controlled Trial / Multicenter Study / Comparative Study
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-29201853
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://dspace.library.uu.nl/handle/1874/353354

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.