Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial
Abstract 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-...
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| Format: | Article |
| Language: | English |
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BMC
2018-01-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2423-4 |
| _version_ | 1818952457957408768 |
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| author | Thijs de Rooij Jony van Hilst Koop Bosscha Marcel G. Dijkgraaf Michael F. Gerhards Bas Groot Koerkamp Jeroen Hagendoorn Ignace H. de Hingh Tom M. Karsten Daan J. Lips Misha D. Luyer I. Quintus Molenaar Hjalmar C. van Santvoort T. C. Khé Tran Olivier R. Busch Sebastiaan Festen Marc G. Besselink for the Dutch Pancreatic Cancer Group |
| author_facet | Thijs de Rooij Jony van Hilst Koop Bosscha Marcel G. Dijkgraaf Michael F. Gerhards Bas Groot Koerkamp Jeroen Hagendoorn Ignace H. de Hingh Tom M. Karsten Daan J. Lips Misha D. Luyer I. Quintus Molenaar Hjalmar C. van Santvoort T. C. Khé Tran Olivier R. Busch Sebastiaan Festen Marc G. Besselink for the Dutch Pancreatic Cancer Group |
| author_sort | Thijs de Rooij |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-20T09:50:41Z |
| format | Article |
| id | doaj.art-fd58c7e85c7842c7ac3476cd947a786c |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-20T09:50:41Z |
| publishDate | 2018-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-fd58c7e85c7842c7ac3476cd947a786c2022-12-21T19:44:37ZengBMCTrials1745-62152018-01-0119111010.1186/s13063-017-2423-4Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trialThijs de Rooij0Jony van Hilst1Koop Bosscha2Marcel G. Dijkgraaf3Michael F. Gerhards4Bas Groot Koerkamp5Jeroen Hagendoorn6Ignace H. de Hingh7Tom M. Karsten8Daan J. Lips9Misha D. Luyer10I. Quintus Molenaar11Hjalmar C. van Santvoort12T. C. Khé Tran13Olivier R. Busch14Sebastiaan Festen15Marc G. Besselink16for the Dutch Pancreatic Cancer GroupDepartment of Surgery, Academic Medical Center, Cancer Center AmsterdamDepartment of Surgery, Academic Medical Center, Cancer Center AmsterdamDepartment of Surgery, Jeroen Bosch HospitalClinical Research Unit, Academic Medical CenterDepartment of Surgery, Onze Lieve Vrouwe GasthuisDepartment of Surgery, Erasmus University Medical CenterDepartment of Surgery, University Medical Center UtrechtDepartment of Surgery, Catharina HospitalDepartment of Surgery, Onze Lieve Vrouwe GasthuisDepartment of Surgery, Jeroen Bosch HospitalDepartment of Surgery, Catharina HospitalDepartment of Surgery, University Medical Center UtrechtDepartment of Surgery, Academic Medical Center, Cancer Center AmsterdamDepartment of Surgery, Erasmus University Medical CenterDepartment of Surgery, Academic Medical Center, Cancer Center AmsterdamDepartment of Surgery, Onze Lieve Vrouwe GasthuisDepartment of Surgery, Academic Medical Center, Cancer Center AmsterdamAbstract 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.http://link.springer.com/article/10.1186/s13063-017-2423-4Minimally invasiveLaparoscopicPancreatoduodenectomyWhippleRobot-assisted |
| spellingShingle | Thijs de Rooij Jony van Hilst Koop Bosscha Marcel G. Dijkgraaf Michael F. Gerhards Bas Groot Koerkamp Jeroen Hagendoorn Ignace H. de Hingh Tom M. Karsten Daan J. Lips Misha D. Luyer I. Quintus Molenaar Hjalmar C. van Santvoort T. C. Khé Tran Olivier R. Busch Sebastiaan Festen Marc G. Besselink for the Dutch Pancreatic Cancer Group Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial Trials Minimally invasive Laparoscopic Pancreatoduodenectomy Whipple Robot-assisted |
| title | Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial |
| title_full | Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial |
| title_fullStr | Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial |
| title_full_unstemmed | Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial |
| title_short | Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial |
| title_sort | minimally invasive versus open pancreatoduodenectomy leopard 2 study protocol for a randomized controlled trial |
| topic | Minimally invasive Laparoscopic Pancreatoduodenectomy Whipple Robot-assisted |
| url | http://link.springer.com/article/10.1186/s13063-017-2423-4 |
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