微创与开放远端胰腺切除术（LEOPARD）：一项随机对照试验的研究方案
Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial.
作者信息
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, 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, de Kleine Ruben H, van Laarhoven Cornelis J, Lips Daan J, Luyer Misha D, Molenaar I Quintus, Nieuwenhuijs Vincent B, Patijn Gijs A, Roos Daphne, Scheepers Joris J, van der Schelling George P, Steenvoorde Pascal, Swijnenburg Rutger-Jan, Wijsman Jan H, Abu Hilal Moh'd, Busch Olivier R, Besselink Marc G
机构信息
Department of Surgery, Academic Medical Center, PO Box 22660, Amsterdam, AZ 1105, The Netherlands.
Department of Surgery, St Antonius Hospital, PO Box 2500, Nieuwegein, EM 3430, The Netherlands.
出版信息
Trials. 2017 Apr 8;18(1):166. doi: 10.1186/s13063-017-1892-9.
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.
背景
观察性队列研究表明，与开放性远端胰腺切除术（ODP）相比，微创远端胰腺切除术（MIDP）具有更好的短期预后，如术中失血更少、发病率更低、住院时间更短以及总成本降低。鉴于病例匹配研究未能证实MIDP的优越性，适应证的混杂因素可能影响了这些结果。这凸显了目前缺乏的多中心随机对照试验的必要性。我们假设，即使在强化康复环境下，MIDP后功能恢复的时间也比ODP短。
方法
LEOPARD是一项在荷兰胰腺癌研究组的所有17个中心进行的随机对照、平行组、患者盲法、多中心优效性试验。总共102例有症状的良性、癌前或恶性疾病患者将被随机分配在强化康复环境下接受MIDP或ODP。主要结局是功能恢复的时间（天），定义如下：在术前水平独立活动、仅用口服药物即可充分控制疼痛、能够维持足够（即>50%）的每日所需热量摄入、无需静脉输液且无感染迹象。次要结局是手术和术后结局，包括临床相关并发症、死亡率、生活质量和成本。
讨论
LEOPARD试验旨在研究在强化康复环境下，与ODP相比，MIDP是否能缩短功能恢复时间。
试验注册
荷兰试验注册库，NTR5188。于2015年4月9日注册。
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