7 results on '"van Hilst, Jony"'
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2. Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial
- Author
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MS CGO, Cancer, MS HOD, de Graaf, Nine, Emmen, Anouk M.L.H., Ramera, Marco, Björnsson, Bergthor, Boggi, Ugo, Bruna, Caro L., Busch, Olivier R., Daams, Freek, Ferrari, Giovanni, Festen, Sebastiaan, van Hilst, Jony, D’Hondt, Mathieu, Ielpo, Benedetto, Keck, Tobias, Khatkov, Igor E., Koerkamp, Bas Groot, Lips, Daan J., Luyer, Misha D.P., Mieog, J. Sven D., Morelli, Luca, Molenaar, I. Quintus, van Santvoort, Hjalmar C., Sprangers, Mirjam A.G., Ferrari, Clarissa, Berkhof, Johannes, Maisonneuve, Patrick, Abu Hilal, Mohammad, Besselink, Marc G., MS CGO, Cancer, MS HOD, de Graaf, Nine, Emmen, Anouk M.L.H., Ramera, Marco, Björnsson, Bergthor, Boggi, Ugo, Bruna, Caro L., Busch, Olivier R., Daams, Freek, Ferrari, Giovanni, Festen, Sebastiaan, van Hilst, Jony, D’Hondt, Mathieu, Ielpo, Benedetto, Keck, Tobias, Khatkov, Igor E., Koerkamp, Bas Groot, Lips, Daan J., Luyer, Misha D.P., Mieog, J. Sven D., Morelli, Luca, Molenaar, I. Quintus, van Santvoort, Hjalmar C., Sprangers, Mirjam A.G., Ferrari, Clarissa, Berkhof, Johannes, Maisonneuve, Patrick, Abu Hilal, Mohammad, and Besselink, Marc G.
- Published
- 2023
3. Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial.
- Author
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van Hilst, Jony, Korrel, Maarten, Lof, Sanne, de Rooij, Thijs, Vissers, Frederique, Al-Sarireh, Bilal, Alseidi, Adnan, Bateman, Adrian C., Björnsson, Bergthor, Boggi, Ugo, Bratlie, Svein Olav, Busch, Olivier, Butturini, Giovanni, Casadei, Riccardo, Dijk, Frederike, Dokmak, Safi, Edwin, Bjorn, van Eijck, Casper, Esposito, Alessandro, and Fabre, Jean-Michel
- Abstract
Background: Recently, the first randomized trials comparing minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) for non-malignant and malignant disease showed a 2-day reduction in time to functional recovery after MIDP. However, for pancreatic ductal adenocarcinoma (PDAC), concerns have been raised regarding the oncologic safety (i.e., radical resection, lymph node retrieval, and survival) of MIDP, as compared to ODP. Therefore, a randomized controlled trial comparing MIDP and ODP in PDAC regarding oncological safety is warranted. We hypothesize that the microscopically radical resection (R0) rate is non-inferior for MIDP, as compared to ODP.Methods/design: DIPLOMA is an international randomized controlled, patient- and pathologist-blinded, non-inferiority trial performed in 38 pancreatic centers in Europe and the USA. A total of 258 patients with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC of the pancreatic body or tail will be randomly allocated to MIDP (laparoscopic or robot-assisted) or ODP in a 1:1 ratio. The primary outcome is the microscopically radical resection margin (R0, distance tumor to pancreatic transection and posterior margin ≥ 1 mm), which is assessed using a standardized histopathology assessment protocol. The sample size is calculated with the following assumptions: 5% one-sided significance level (α), 80% power (1-β), expected R0 rate in the open group of 58%, expected R0 resection rate in the minimally invasive group of 67%, and a non-inferiority margin of 7%. Secondary outcomes include time to functional recovery, operative outcomes (e.g., blood loss, operative time, and conversion to open surgery), other histopathology findings (e.g., lymph node retrieval, perineural- and lymphovascular invasion), postoperative outcomes (e.g., clinically relevant complications, hospital stay, and administration of adjuvant treatment), time and site of disease recurrence, survival, quality of life, and costs. Follow-up will be performed at the outpatient clinic after 6, 12, 18, 24, and 36 months postoperatively.Discussion: The DIPLOMA trial is designed to investigate the non-inferiority of MIDP versus ODP regarding the microscopically radical resection rate of PDAC in an international setting.Trial Registration: ISRCTN registry ISRCTN44897265 . Prospectively registered on 16 April 2018. [ABSTRACT FROM AUTHOR]- Published
- 2021
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4. Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial
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de Rooij, Thijs, van Hilst, Jony, Bosscha, Koop, Dijkgraaf, Marcel G., Gerhards, Michael F., Koerkamp, Bas Groot, Hagendoorn, Jeroen, de Hingh, Ignace H., Karsten, Tom M., Lips, Daan J., Luyer, Misha D., Molenaar, I. Quintus, van Santvoort, Hjalmar C., Tran, T. C.Khé, Busch, Olivier R., Festen, Sebastiaan, Besselink, Marc G., for the Dutch Pancreatic Cancer Group, CCA - Cancer Treatment and Quality of Life, Graduate School, APH - Methodology, Clinical Research Unit, Amsterdam Gastroenterology Endocrinology Metabolism, Other departments, Surgery, Cardiology, Erasmus MC other, and Pediatric Surgery
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Time Factors ,Medicine (miscellaneous) ,law.invention ,Study Protocol ,0302 clinical medicine ,Superiority Trial ,Postoperative Complications ,Quality of life ,Randomized controlled trial ,Robotic Surgical Procedures ,law ,Data monitoring committee ,Medicine ,Multicenter Studies as Topic ,Pancreaticoduodenectomy/adverse effects ,Pharmacology (medical) ,Netherlands ,Randomized Controlled Trials as Topic ,lcsh:R5-920 ,Pancreatoduodenectomy ,Robot-assisted ,Whipple ,Phase III as Topic ,Treatment Outcome ,Laparoscopy/adverse effects ,030220 oncology & carcinogenesis ,Postoperative Complications/etiology ,030211 gastroenterology & hepatology ,lcsh:Medicine (General) ,medicine.medical_specialty ,Pancreatic Diseases/diagnosis ,Malignant disease ,Pancreaticoduodenectomy ,03 medical and health sciences ,Laparoscopic ,Clinical Trials, Phase II as Topic ,Blood loss ,Journal Article ,Humans ,Clinical Trials ,Minimally invasive ,Robotic Surgical Procedures/adverse effects ,Protocol (science) ,business.industry ,Phase II as Topic ,Pancreatic Diseases ,Recovery of Function ,Surgery ,Clinical Trials, Phase III as Topic ,Observational study ,Laparoscopy ,business - 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 (
- Published
- 2018
5. Minimally invasive versus open distal pancreatectomy (LEOPARD) : study protocol for a randomized controlled trial
- Author
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de Rooij, Thijs, van Hilst, Jony, Vogel, Jantien A, van Santvoort, Hjalmar C, de Boer, Marieke T., Boerma, Djamila, van den Boezem, Peter B., Bonsing, Bert A., Bosscha, Koop, Coene, Peter-Paul, Daams, Freek, van Dam, Ronald M., Dijkgraaf, Marcel G. W., van Eijck, Casper H., Festen, Sebastiaan, Gerhards, Michael F., Groot Koerkamp, Bas, Hagendoorn, Jeroen, van der Harst, Erwin, de Hingh, Ignace H., Dejong, Cees H., Kazemier, Geert, Klaase, Joost M., de Kleine, Ruben H J, van Laarhoven, Cornelis J., Lips, Daan J., Luyer, Misha Dp, Molenaar, I Quintus, Nieuwenhuijs, Vincent B., Patijn, Gijs A., Roos, Daphne, Scheepers, Joris Jg, Van Der Schelling, George P., Steenvoorde, Pascal, Swijnenburg, Rutger-Jan, Wijsman, Jan H, Abu Hilal, Moh'd, Busch, Olivier R C, Besselink, Marc G H, Dutch Pancreatic Cancer Group, de Rooij, Thijs, van Hilst, Jony, Vogel, Jantien A, van Santvoort, Hjalmar C, de Boer, Marieke T., Boerma, Djamila, van den Boezem, Peter B., Bonsing, Bert A., Bosscha, Koop, Coene, Peter-Paul, Daams, Freek, van Dam, Ronald M., Dijkgraaf, Marcel G. W., van Eijck, Casper H., Festen, Sebastiaan, Gerhards, Michael F., Groot Koerkamp, Bas, Hagendoorn, Jeroen, van der Harst, Erwin, de Hingh, Ignace H., Dejong, Cees H., Kazemier, Geert, Klaase, Joost M., de Kleine, Ruben H J, van Laarhoven, Cornelis J., Lips, Daan J., Luyer, Misha Dp, Molenaar, I Quintus, Nieuwenhuijs, Vincent B., Patijn, Gijs A., Roos, Daphne, Scheepers, Joris Jg, Van Der Schelling, George P., Steenvoorde, Pascal, Swijnenburg, Rutger-Jan, Wijsman, Jan H, Abu Hilal, Moh'd, Busch, Olivier R C, Besselink, Marc G H, and Dutch Pancreatic Cancer Group
- Published
- 2017
6. Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial
- Author
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MS CGO, Cancer, de Rooij, Thijs, van Hilst, Jony, Vogel, Jantien A, van Santvoort, Hjalmar C, de Boer, Marieke T., Boerma, Djamila, van den Boezem, Peter B., Bonsing, Bert A., Bosscha, Koop, Coene, Peter-Paul, Daams, Freek, van Dam, Ronald M., Dijkgraaf, Marcel G. W., van Eijck, Casper H., Festen, Sebastiaan, Gerhards, Michael F., Groot Koerkamp, Bas, Hagendoorn, Jeroen, van der Harst, Erwin, de Hingh, Ignace H., Dejong, Cees H., Kazemier, Geert, Klaase, Joost M., de Kleine, Ruben H J, van Laarhoven, Cornelis J., Lips, Daan J., Luyer, Misha Dp, Molenaar, I Quintus, Nieuwenhuijs, Vincent B., Patijn, Gijs A., Roos, Daphne, Scheepers, Joris Jg, Van Der Schelling, George P., Steenvoorde, Pascal, Swijnenburg, Rutger-Jan, Wijsman, Jan H, Abu Hilal, Moh'd, Busch, Olivier R C, Besselink, Marc G H, Dutch Pancreatic Cancer Group, MS CGO, Cancer, de Rooij, Thijs, van Hilst, Jony, Vogel, Jantien A, van Santvoort, Hjalmar C, de Boer, Marieke T., Boerma, Djamila, van den Boezem, Peter B., Bonsing, Bert A., Bosscha, Koop, Coene, Peter-Paul, Daams, Freek, van Dam, Ronald M., Dijkgraaf, Marcel G. W., van Eijck, Casper H., Festen, Sebastiaan, Gerhards, Michael F., Groot Koerkamp, Bas, Hagendoorn, Jeroen, van der Harst, Erwin, de Hingh, Ignace H., Dejong, Cees H., Kazemier, Geert, Klaase, Joost M., de Kleine, Ruben H J, van Laarhoven, Cornelis J., Lips, Daan J., Luyer, Misha Dp, Molenaar, I Quintus, Nieuwenhuijs, Vincent B., Patijn, Gijs A., Roos, Daphne, Scheepers, Joris Jg, Van Der Schelling, George P., Steenvoorde, Pascal, Swijnenburg, Rutger-Jan, Wijsman, Jan H, Abu Hilal, Moh'd, Busch, Olivier R C, Besselink, Marc G H, and Dutch Pancreatic Cancer Group
- Published
- 2017
7. Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial.
- Author
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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 PP, Daams F, van Dam RM, Dijkgraaf MG, van Eijck CH, Festen S, Gerhards MF, Groot Koerkamp B, Hagendoorn J, van der Harst E, de Hingh IH, Dejong CH, Kazemier G, Klaase J, de Kleine RH, van Laarhoven CJ, Lips DJ, Luyer MD, Molenaar IQ, Nieuwenhuijs VB, Patijn GA, Roos D, Scheepers JJ, van der Schelling GP, Steenvoorde P, Swijnenburg RJ, Wijsman JH, Abu Hilal M, Busch OR, and Besselink MG
- Subjects
- Administration, Oral, Analgesics administration & dosage, Clinical Protocols, Cost-Benefit Analysis, Eating, Energy Intake, Health Status, Hospital Costs, Humans, Netherlands, Pain Measurement, Pain, Postoperative etiology, Pain, Postoperative prevention & control, Pancreatectomy adverse effects, Pancreatectomy economics, Quality of Life, Recovery of Function, Research Design, Time Factors, Treatment Outcome, Laparoscopy adverse effects, Laparoscopy economics, Pancreatectomy methods, Robotic Surgical Procedures adverse effects, Robotic Surgical Procedures economics
- 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.
- Published
- 2017
- Full Text
- View/download PDF
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