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

Thijs de Rooij, Jony van Hilst, Jantien A. Vogel, Hjalmar C. van Santvoort, Marieke T. de Boer, Djamila Boerma, Peter B. van den Boezem, Bert A. Bonsing, Koop Bosscha, Peter-Paul Coene, Freek Daams, Ronald M. van Dam, Marcel G. Dijkgraaf, Casper H. van Eijck, Sebastiaan Festen, Michael F. Gerhards, Bas Groot Koerkamp, Jeroen Hagendoorn, Erwin van der Harst, Ignace H. de HinghCees H. Dejong, Geert Kazemier, Joost Klaase, Ruben H. de Kleine, Cornelis J. van Laarhoven, Daan J. Lips, Misha D. Luyer, I. Quintus Molenaar, Vincent B. Nieuwenhuijs, Gijs A. Patijn, Daphne Roos, Joris J. Scheepers, George P. van der Schelling, Pascal Steenvoorde, Rutger-Jan Swijnenburg, Jan H. Wijsman, Moh'd Abu Hilal, Olivier R. Busch, Marc G. Besselink*, Dutch Pancreatic Canc Grp

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

31 Citations (Web of Science)

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.

Original languageEnglish
Article number166
Number of pages10
JournalTrials
Volume18
DOIs
Publication statusPublished - 8 Apr 2017

Keywords

  • Minimally invasive
  • Laparoscopic
  • Robot-assisted
  • Distal pancreatectomy
  • Pancreatic surgery
  • Pancreatic cancer
  • INTERNATIONAL STUDY-GROUP
  • DUCTAL ADENOCARCINOMA
  • IDEAL FRAMEWORK
  • SURGERY ISGPS
  • LONG-TERM
  • MALIGNANT-DISEASE
  • CLINICAL-TRIAL
  • DEFINITION
  • PANCREATOSPLENECTOMY
  • BENIGN

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