A well-implemented ERAS protocol with good compliance is associated with a reduction in medical complications and length of hospital stay .
Enhanced recovery after surgery ( ERAS ) pathways are now implemented worldwide with strong evidence that adhesion to such protocol reduces medical complications , costs and hospital stay .
This concept has been applied for pancreatic surgery since the first published guidelines in 2012 .
This study presents the up date d ERAS recommendations for  pancreatoduodenectomy ( PD )  based on the best available evidence and on expert consensus .
Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial
Background Data from observational studies suggest that minimally invasive pancreatoduodenectomy ( MIPD ) is superior to open pancreatoduodenectomy regarding intraoperative blood loss , postoperative morbidity , and length of hospital stay , without increasing total costs . However , several case-matched studies failed to demonstrate superiority of MIPD , and large registry studies from the USA even suggested increased mortality for MIPDs performed in low-volume ( < 10 MIPDs annually ) centers . R and omized controlled multicenter trials are lacking but clearly required . We hypothesize that time to functional recovery is shorter after MIPD compared with open pancreatoduodenectomy , even in an enhanced recovery setting . Methods / design LEOPARD-2 is a r and omized controlled , parallel-group , patient-blinded , multicenter , phase 2/3 , superiority trial in centers that completed the Dutch Pancreatic Cancer Group LAELAPS-2 training program for laparoscopic pancreatoduodenectomy or LAELAPS-3 training program for robot-assisted pancreatoduodenectomy and have performed ≥ 20 MIPDs . A total of 136 patients with symptomatic benign , premalignant , or malignant disease will be r and omly assigned to undergo minimally invasive or open pancreatoduodenectomy in an enhanced recovery setting . After the first 40 patients ( phase 2 ) , the data safety monitoring board will assess safety outcomes ( not blinded for treatment allocation ) and decide on continuation to phase 3 . Patients from phase 2 will then be included in phase 3 . The primary outcome measure is time ( days ) to functional recovery . All patients will be blinded for the surgical approach , at least until postoperative day 5 , but preferably until functional recovery has been attained . Secondary outcome measures are operative and postoperative outcomes , including clinical ly relevant complications , mortality , quality of life , and costs . Discussion The LEOPARD-2 trial is design ed to assess whether MIPD  reduces time to functional recovery , as compared with open pancreatoduodenectomy in an enhanced recovery setting .Trial registration Netherl and s Trial Register , NTR5689 . Registered on 2 March 2016
A well-implemented ERAS protocol with good compliance is associated with a reduction in medical complications and length of hospital stay .
Enhanced recovery after surgery ( ERAS ) pathways are now implemented worldwide with strong evidence that adhesion to such protocol reduces medical complications , costs and hospital stay .
This concept has been applied for pancreatic surgery since the first published guidelines in 2012 .
This study presents the up date d ERAS recommendations for  pancreatoduodenectomy ( PD )  based on the best available evidence and on expert consensus .