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Trials. 2017 Apr 8;18(1):166. doi: 10.1186/s13063-017-1892-9.

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

Author information

1
Department of Surgery, Academic Medical Center, PO Box 22660, Amsterdam, AZ 1105, The Netherlands.
2
Department of Surgery, St Antonius Hospital, PO Box 2500, Nieuwegein, EM 3430, The Netherlands.
3
Department of Surgery, University Medical Center Groningen, PO Box 30 001, Groningen, RB 9700, The Netherlands.
4
Department of Surgery, Radboud University Nijmegen Medical Center, PO Box 9101, Nijmegen, HB 6500, The Netherlands.
5
Department of Surgery, Leiden University Medical Center, PO Box 9600, Leiden, ZA 2333, The Netherlands.
6
Department of Surgery, Jeroen Bosch Hospital, PO Box 90153, Den Bosch, ME 5200, The Netherlands.
7
Department of Surgery, Maasstad Hospital, PO Box 9100, Rotterdam, AC 3007, The Netherlands.
8
Department of Surgery, VU University Medical Center, PO Box 7057, Amsterdam, HV 1081, The Netherlands.
9
Department of Surgery, Maastricht University Medical Center, PO Box 5800, Maastricht, AZ 6202, The Netherlands.
10
Clinical Research Unit, Academic Medical Center, PO Box 22660, Amsterdam, DD 1100, The Netherlands.
11
Department of Surgery, Erasmus University Medical Center, PO Box 2040, Rotterdam, CA 3000, The Netherlands.
12
Department of Surgery, Onze Lieve Vrouwe Gasthuis, PO Box 95500, Amsterdam, HM 1090, The Netherlands.
13
Department of Surgery, University Medical Center Utrecht, PO Box 85 500, Utrecht, GA 3508, The Netherlands.
14
Department of Surgery, Catharina Hospital, PO Box 1350, Eindhoven, ZA 5602, The Netherlands.
15
NUTRIM School for Nutrition and Translational Research in Metabolism, PO Box 5800, Maastricht, AZ 6202, The Netherlands.
16
Department of Surgery, Medisch Spectrum Twente, PO Box 50 000, Enschede, KA 7500, The Netherlands.
17
Department of Surgery, Isala Clinics, PO Box 10 400, Zwolle, AB 8025, The Netherlands.
18
Department of Surgery, Reinier de Graag Gasthuis, PO Box 5011, Delft, GA 2600, The Netherlands.
19
Department of Surgery, Amphia Hospital, PO Box 90 158, Breda, RK 4800, The Netherlands.
20
Department of Surgery, Southampton University Hospital NHS Foundation Trust, Southampton, SO166YD, UK.
21
Department of Surgery, Academic Medical Center, PO Box 22660, Amsterdam, DD 1100, The Netherlands.
22
Department of Surgery, Academic Medical Center, PO Box 22660, Amsterdam, DD 1100, The Netherlands. m.g.besselink@amc.nl.

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:

Distal pancreatectomy; Laparoscopic; Minimally invasive; Pancreatic cancer; Pancreatic surgery; Robot-assisted

PMID:
28388963
PMCID:
PMC5385082
DOI:
10.1186/s13063-017-1892-9
[Indexed for MEDLINE]
Free PMC Article

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