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 .
Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours (LEOPARD-2): a multicentre, patient-blinded, randomised controlled phase 2/3 trial.
BACKGROUND Laparoscopic pancreatoduodenectomy may improve postoperative recovery compared with open pancreatoduodenectomy . However , there are concerns that the extensive learning curve of this complex procedure could increase the risk of complications . We aim ed to assess whether laparoscopic pancreatoduodenectomy could reduce time to functional recovery compared with open pancreatoduodenectomy . METHODS This multicentre , patient-blinded , parallel-group , r and omised controlled phase 2/3 trial was performed in four centres in the Netherl and s that each do 20 or more pancreatoduodenectomies annually ; surgeons had to have completed a dedicated training programme for laparoscopic pancreatoduodenectomy and have done 20 or more laparoscopic pancreatoduodenectomies before trial participation . Patients with a benign , premalignant , or malignant indication for pancreatoduodenectomy , without signs of vascular involvement , were r and omly assigned ( 1:1 ) to undergo either laparoscopic or open pancreatoduodenectomy using a central web-based system . R and omisation was stratified for annual case volume and preoperative estimated risk of pancreatic fistula . Patients were blinded to treatment allocation . Analysis was done according to the intention-to-treat principle . The main objective of the phase 2 part of the trial was to assess the safety of laparoscopic pancreatoduodenectomy ( complications and mortality ) , and the primary outcome of phase 3 was time to functional recovery in days , defined as all of the following : adequate pain control with only oral analgesia ; independent mobility ; ability to maintain more than 50 % of the daily required caloric intake ; no need for intravenous fluid administration ; and no signs of infection ( temperature < 38·5 ° C ) . This trial is registered with Trialregister.nl , number NTR5689 . FINDINGS Between May 13 and Dec 20 , 2016 , 42 patients were r and omised in the phase 2 part of the trial . Two patients did not receive surgery and were excluded from analyses in accordance with the study protocol . Three ( 15 % ) of 20 patients died within 90 days after laparoscopic pancreatoduodenectomy , compared with none of 20 patients after open pancreatoduodenectomy . Based on safety data from the phase 2 part of the trial , the data and safety monitoring board and protocol committee agreed to proceed with phase 3 . Between Jan 31 and Nov 14 , 2017 , 63 additional patients were r and omised in phase 3 of the trial . Four patients did not receive surgery and were excluded from analyses in accordance with the study protocol . After r and omisation of 105 patients ( combining patients from both phase 2 and phase 3 ) , of whom 99 underwent surgery , the trial was prematurely terminated by the data and safety monitoring board because of a difference in 90-day complication-related mortality ( five [ 10 % ] of 50 patients in the laparoscopic pancreatoduodenectomy group vs one [ 2 % ] of 49 in the open pancreatoduodenectomy group ; risk ratio [ RR ] 4·90 [ 95 % CI 0·59 - 40·44 ] ; p=0·20 ) . Median time to functional recovery was 10 days ( 95 % CI 5 - 15 ) after laparoscopic pancreatoduodenectomy versus 8 days ( 95 % CI 7 - 9 ) after open pancreatoduodenectomy ( log-rank p=0·80 ) . Clavien-Dindo grade III or higher complications ( 25 [ 50 % ] of 50 patients after laparoscopic pancreatoduodenectomy vs 19 [ 39 % ] of 49 after open pancreatoduodenectomy ; RR 1·29 [ 95 % CI 0·82 - 2·02 ] ; p=0·26 ) and grade B/C postoperative pancreatic fistulas ( 14 [ 28 % ] vs 12 [ 24 % ] ; RR 1·14 [ 95 % CI 0·59 - 2·22 ] ; p=0·69 ) were comparable between groups . INTERPRETATION Although not statistically significant , laparoscopic pancreatoduodenectomy was associated with more complication-related deaths than was open pancreatoduodenectomy , and there was no difference between groups in time to functional recovery . These safety concerns were unexpected and worrisome , especially in the setting of trained surgeons working in centres performing 20 or more pancreatoduodenectomies annually . Experience , learning curve , and annual volume might have influenced the outcomes ; future research should focus on these issues . FUNDING Grant for investigator-initiated studies by Johnson & Johnson Medical Limited
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 .