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,...
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| Format: | Article |
| Language: | English |
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BMC
2017-04-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1892-9 |
| _version_ | 1828229970687688704 |
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| author | 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 Hingh Cees 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 for the Dutch Pancreatic Cancer Group |
| author_facet | 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 Hingh Cees 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 for the Dutch Pancreatic Cancer Group |
| author_sort | Thijs de Rooij |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-04-12T18:41:19Z |
| format | Article |
| id | doaj.art-48126af9caf94e8aa02a77e625589467 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T18:41:19Z |
| publishDate | 2017-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-48126af9caf94e8aa02a77e6255894672022-12-22T03:20:45ZengBMCTrials1745-62152017-04-0118111010.1186/s13063-017-1892-9Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trialThijs de Rooij0Jony van Hilst1Jantien A. Vogel2Hjalmar C. van Santvoort3Marieke T. de Boer4Djamila Boerma5Peter B. van den Boezem6Bert A. Bonsing7Koop Bosscha8Peter-Paul Coene9Freek Daams10Ronald M. van Dam11Marcel G. Dijkgraaf12Casper H. van Eijck13Sebastiaan Festen14Michael F. Gerhards15Bas Groot Koerkamp16Jeroen Hagendoorn17Erwin van der Harst18Ignace H. de Hingh19Cees H. Dejong20Geert Kazemier21Joost Klaase22Ruben H. de Kleine23Cornelis J. van Laarhoven24Daan J. Lips25Misha D. Luyer26I. Quintus Molenaar27Vincent B. Nieuwenhuijs28Gijs A. Patijn29Daphne Roos30Joris J. Scheepers31George P. van der Schelling32Pascal Steenvoorde33Rutger-Jan Swijnenburg34Jan H. Wijsman35Moh’d Abu Hilal36Olivier R. Busch37Marc G. Besselink38for the Dutch Pancreatic Cancer GroupDepartment of Surgery, Academic Medical CenterDepartment of Surgery, Academic Medical CenterDepartment of Surgery, Academic Medical CenterDepartment of Surgery, St Antonius HospitalDepartment of Surgery, University Medical Center GroningenDepartment of Surgery, St Antonius HospitalDepartment of Surgery, Radboud University Nijmegen Medical CenterDepartment of Surgery, Leiden University Medical CenterDepartment of Surgery, Jeroen Bosch HospitalDepartment of Surgery, Maasstad HospitalDepartment of Surgery, VU University Medical CenterDepartment of Surgery, Maastricht University Medical CenterClinical Research Unit, Academic Medical CenterDepartment of Surgery, Erasmus University Medical CenterDepartment of Surgery, Onze Lieve Vrouwe GasthuisDepartment of Surgery, Onze Lieve Vrouwe GasthuisDepartment of Surgery, Erasmus University Medical CenterDepartment of Surgery, University Medical Center UtrechtDepartment of Surgery, Maasstad HospitalDepartment of Surgery, Catharina HospitalDepartment of Surgery, Maastricht University Medical CenterDepartment of Surgery, VU University Medical CenterDepartment of Surgery, Medisch Spectrum TwenteDepartment of Surgery, University Medical Center GroningenDepartment of Surgery, Radboud University Nijmegen Medical CenterDepartment of Surgery, Jeroen Bosch HospitalDepartment of Surgery, Catharina HospitalDepartment of Surgery, University Medical Center UtrechtDepartment of Surgery, Isala ClinicsDepartment of Surgery, Isala ClinicsDepartment of Surgery, Reinier de Graag GasthuisDepartment of Surgery, Reinier de Graag GasthuisDepartment of Surgery, Amphia HospitalDepartment of Surgery, Medisch Spectrum TwenteDepartment of Surgery, Leiden University Medical CenterDepartment of Surgery, Amphia HospitalDepartment of Surgery, Southampton University Hospital NHS Foundation TrustDepartment of Surgery, Academic Medical CenterDepartment of Surgery, Academic Medical CenterAbstract 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 2015http://link.springer.com/article/10.1186/s13063-017-1892-9Minimally invasiveLaparoscopicRobot-assistedDistal pancreatectomyPancreatic surgeryPancreatic cancer |
| spellingShingle | 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 Hingh Cees 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 for the Dutch Pancreatic Cancer Group Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial Trials Minimally invasive Laparoscopic Robot-assisted Distal pancreatectomy Pancreatic surgery Pancreatic cancer |
| title | Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial |
| title_full | Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial |
| title_fullStr | Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial |
| title_full_unstemmed | Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial |
| title_short | Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial |
| title_sort | minimally invasive versus open distal pancreatectomy leopard study protocol for a randomized controlled trial |
| topic | Minimally invasive Laparoscopic Robot-assisted Distal pancreatectomy Pancreatic surgery Pancreatic cancer |
| url | http://link.springer.com/article/10.1186/s13063-017-1892-9 |
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