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

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.

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

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Analgesics / administration & dosage
  • Clinical Protocols
  • Cost-Benefit Analysis
  • Eating
  • Energy Intake
  • Health Status
  • Hospital Costs
  • Humans
  • Laparoscopy* / adverse effects
  • Laparoscopy* / economics
  • Netherlands
  • Pain Measurement
  • Pain, Postoperative / etiology
  • Pain, Postoperative / prevention & control
  • Pancreatectomy / adverse effects
  • Pancreatectomy / economics
  • Pancreatectomy / methods*
  • Quality of Life
  • Recovery of Function
  • Research Design
  • Robotic Surgical Procedures* / adverse effects
  • Robotic Surgical Procedures* / economics
  • Time Factors
  • Treatment Outcome


  • Analgesics

Associated data

  • NTR/NTR5188