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

作者：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; Koerkamp Bas Groot; 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

来源：Trials, 2017, 18(1): 166.

DOI：10.1186/s13063-017-1892-9

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

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.

• 出版日期2017-4-8