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. W. Dijkgraaf; Casper H. van Eijck; Sebastiaan Festen; Michael F. Gerhards; Bas Groot Koerkamp; Jeroen Hagendoorn; Erwin van der Harst; Ignace H. de Hingh; Cees H. Dejong; Geert Kazemier; Joost M. Klaase; Ruben H J de Kleine; Cornelis J. van Laarhoven; Daan J. Lips; Misha Dp Luyer; I Quintus Molenaar; Vincent B. Nieuwenhuijs; Gijs A. Patijn; Daphne Roos; Joris Jg Scheepers; George P. Van Der Schelling; Pascal Steenvoorde; Rutger-Jan Swijnenburg; Jan H Wijsman; Moh'd Abu Hilal; Olivier R C Busch; Marc G H Besselink

doi:10.1186/s13063-017-1892-9

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. W. 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 M. Klaase, Ruben H J de Kleine, Cornelis J. van Laarhoven, Daan J. Lips, Misha Dp Luyer, I Quintus Molenaar, Vincent B. Nieuwenhuijs, Gijs A. Patijn, Daphne Roos, Joris Jg Scheepers, George P. Van Der Schelling, Pascal Steenvoorde, Rutger-Jan Swijnenburg, Jan H Wijsman, Moh'd Abu Hilal, Olivier R C Busch, Marc G H Besselink,

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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.

TRIAL REGISTRATION: Dutch Trial Register, NTR5188 . Registered on 9 April 2015.

Original language	English
Article number	166
Pages (from-to)	166
Journal	Trials [E]
Volume	18
Issue number	1
DOIs	https://doi.org/10.1186/s13063-017-1892-9
Publication status	Published - 8 Apr 2017

Keywords

Minimally invasive
Laparoscopic
Robot-assisted
Distal pancreatectomy
Pancreatic surgery
Pancreatic cancer
Hospital Costs
Humans
Clinical Protocols
Recovery of Function
Pain, Postoperative/etiology
Netherlands
Analgesics/administration & dosage
Time Factors
Robotic Surgical Procedures/adverse effects
Eating
Administration, Oral
Treatment Outcome
Energy Intake
Pancreatectomy/adverse effects
Cost-Benefit Analysis
Laparoscopy/adverse effects
Quality of Life
Health Status
Pain Measurement
Research Design

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de Rooij, T., van Hilst, J., Vogel, J. A., van Santvoort, H. C., de Boer, M. T., Boerma, D., van den Boezem, P. B., Bonsing, B. A., Bosscha, K., Coene, P.-P., Daams, F., van Dam, R. M., Dijkgraaf, M. G. W., van Eijck, C. H., Festen, S., Gerhards, M. F., Groot Koerkamp, B., Hagendoorn, J., van der Harst, E. (2017). Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial. Trials [E], 18(1), 166. Article 166. https://doi.org/10.1186/s13063-017-1892-9

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

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.TRIAL REGISTRATION: Dutch Trial Register, NTR5188 . Registered on 9 April 2015.",

keywords = "Minimally invasive, Laparoscopic, Robot-assisted, Distal pancreatectomy, Pancreatic surgery, Pancreatic cancer, Hospital Costs, Humans, Clinical Protocols, Recovery of Function, Pain, Postoperative/etiology, Netherlands, Analgesics/administration & dosage, Time Factors, Robotic Surgical Procedures/adverse effects, Eating, Administration, Oral, Treatment Outcome, Energy Intake, Pancreatectomy/adverse effects, Cost-Benefit Analysis, Laparoscopy/adverse effects, Quality of Life, Health Status, Pain Measurement, Research Design",

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

year = "2017",

month = apr,

day = "8",

doi = "10.1186/s13063-017-1892-9",

language = "English",

volume = "18",

pages = "166",

journal = "Trials [E]",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

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de Rooij, T, van Hilst, J, Vogel, JA, van Santvoort, HC, de Boer, MT, Boerma, D, van den Boezem, PB, Bonsing, BA, Bosscha, K, Coene, P-P, Daams, F, van Dam, RM, Dijkgraaf, MGW, van Eijck, CH, Festen, S, Gerhards, MF, Groot Koerkamp, B, Hagendoorn, J, van der Harst, E, de Hingh, IH, Dejong, CH, Kazemier, G, Klaase, JM, de Kleine, RHJ, van Laarhoven, CJ, Lips, DJ, Luyer, MD, Molenaar, IQ, Nieuwenhuijs, VB, Patijn, GA, Roos, D, Scheepers, JJ, Van Der Schelling, GP, Steenvoorde, P, Swijnenburg, R-J, Wijsman, JH, Abu Hilal, M, Busch, ORC, Besselink, MGH 2017, 'Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial', Trials [E], vol. 18, no. 1, 166, pp. 166. https://doi.org/10.1186/s13063-017-1892-9

TY - JOUR

T1 - Minimally invasive versus open distal pancreatectomy (LEOPARD)

T2 - study protocol for a randomized controlled trial

AU - de Rooij, Thijs

AU - van Hilst, Jony

AU - Vogel, Jantien A

AU - van Santvoort, Hjalmar C

AU - de Boer, Marieke T.

AU - Boerma, Djamila

AU - van den Boezem, Peter B.

AU - Bonsing, Bert A.

AU - Bosscha, Koop

AU - Coene, Peter-Paul

AU - Daams, Freek

AU - van Dam, Ronald M.

AU - Dijkgraaf, Marcel G. W.

AU - van Eijck, Casper H.

AU - Festen, Sebastiaan

AU - Gerhards, Michael F.

AU - Groot Koerkamp, Bas

AU - Hagendoorn, Jeroen

AU - van der Harst, Erwin

AU - de Hingh, Ignace H.

AU - Dejong, Cees H.

AU - Kazemier, Geert

AU - Klaase, Joost M.

AU - de Kleine, Ruben H J

AU - van Laarhoven, Cornelis J.

AU - Lips, Daan J.

AU - Luyer, Misha Dp

AU - Molenaar, I Quintus

AU - Nieuwenhuijs, Vincent B.

AU - Patijn, Gijs A.

AU - Roos, Daphne

AU - Scheepers, Joris Jg

AU - Van Der Schelling, George P.

AU - Steenvoorde, Pascal

AU - Swijnenburg, Rutger-Jan

AU - Wijsman, Jan H

AU - Abu Hilal, Moh'd

AU - Busch, Olivier R C

AU - Besselink, Marc G H

PY - 2017/4/8

Y1 - 2017/4/8

N2 - 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.

AB - 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.

KW - Minimally invasive

KW - Laparoscopic

KW - Robot-assisted

KW - Distal pancreatectomy

KW - Pancreatic surgery

KW - Pancreatic cancer

KW - Hospital Costs

KW - Humans

KW - Clinical Protocols

KW - Recovery of Function

KW - Pain, Postoperative/etiology

KW - Netherlands

KW - Analgesics/administration & dosage

KW - Time Factors

KW - Robotic Surgical Procedures/adverse effects

KW - Eating

KW - Administration, Oral

KW - Treatment Outcome

KW - Energy Intake

KW - Pancreatectomy/adverse effects

KW - Cost-Benefit Analysis

KW - Laparoscopy/adverse effects

KW - Quality of Life

KW - Health Status

KW - Pain Measurement

KW - Research Design

UR - http://www.scopus.com/inward/record.url?scp=85018479860&partnerID=8YFLogxK

U2 - 10.1186/s13063-017-1892-9

DO - 10.1186/s13063-017-1892-9

M3 - Article

C2 - 28388963

SN - 1745-6215

VL - 18

SP - 166

JO - Trials [E]

JF - Trials [E]

IS - 1

M1 - 166

ER -

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

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