TY - JOUR
T1 - Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2)
T2 - Study protocol for a randomized controlled trial
AU - de Rooij, Thijs
AU - van Hilst, Jony
AU - Bosscha, Koop
AU - Dijkgraaf, Marcel G.
AU - Gerhards, Michael F.
AU - Koerkamp, Bas Groot
AU - Hagendoorn, Jeroen
AU - de Hingh, Ignace H.
AU - Karsten, Tom M.
AU - Lips, Daan J.
AU - Luyer, Misha D.
AU - Molenaar, I. Quintus
AU - van Santvoort, Hjalmar C.
AU - Tran, T. C.Khé
AU - Busch, Olivier R.
AU - Festen, Sebastiaan
AU - Besselink, Marc G.
N1 - Publisher Copyright:
© The Author(s). 2018.
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2018/1/1
Y1 - 2018/1/1
N2 - 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. Randomized 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 randomized 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 randomly 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 clinically relevant complications, mortality, quality of life, and costs.DISCUSSION: The LEOPARD-2 trial is designed to assess whether MIPD reduces time to functional recovery, as compared with open pancreatoduodenectomy in an enhanced recovery setting.TRIAL REGISTRATION: Netherlands Trial Register, NTR5689 . Registered on 2 March 2016.
AB - 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. Randomized 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 randomized 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 randomly 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 clinically relevant complications, mortality, quality of life, and costs.DISCUSSION: The LEOPARD-2 trial is designed to assess whether MIPD reduces time to functional recovery, as compared with open pancreatoduodenectomy in an enhanced recovery setting.TRIAL REGISTRATION: Netherlands Trial Register, NTR5689 . Registered on 2 March 2016.
KW - Laparoscopic
KW - Minimally invasive
KW - Pancreatoduodenectomy
KW - Robot-assisted
KW - Whipple
KW - Humans
KW - Postoperative Complications/etiology
KW - Treatment Outcome
KW - Pancreatic Diseases/diagnosis
KW - Pancreaticoduodenectomy/adverse effects
KW - Recovery of Function
KW - Randomized Controlled Trials as Topic
KW - Clinical Trials, Phase III as Topic
KW - Netherlands
KW - Multicenter Studies as Topic
KW - Time Factors
KW - Laparoscopy/adverse effects
KW - Clinical Trials, Phase II as Topic
KW - Robotic Surgical Procedures/adverse effects
UR - http://www.scopus.com/inward/record.url?scp=85042465709&partnerID=8YFLogxK
U2 - 10.1186/s13063-017-2423-4
DO - 10.1186/s13063-017-2423-4
M3 - Article
C2 - 29298706
AN - SCOPUS:85042465709
SN - 1745-6215
VL - 19
SP - 1
EP - 10
JO - Trials
JF - Trials
IS - 1
M1 - 1
ER -