Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours (LEOPARD-2): a multicentre, patient-blinded, randomised controlled phase 2/3 trial
| Autor: | Jony van Hilst, Thijs de Rooij, Koop Bosscha, David J Brinkman, Susan van Dieren, Marcel G Dijkgraaf, Michael F Gerhards, Ignace H de Hingh, Tom M Karsten, Daniel J Lips, Misha D Luyer, Olivier R Busch, Sebastiaan Festen, Marc G Besselink, Jony Van Hilst, Thijs De Rooij, Susan Van Dieren, Ignace H De Hingh, Hendrik A Marsman, Thomas M Van Gulik, Dennis A Wicherts, Wietse J Eshuis, Luna A Stibbe, Els JM Nieveen van Dijkum, Janine E Van Hooft, Paul Fockens, Hanneke W Van Laarhoven, Johanna W Wilmink, Marcel J Van de Vijver, Maarten F Bijlsma, Joanne Verheij, C Yung Nio, Krijn P Van Lienden, Geertjan Van Tienhoven, Annuska Schoorlemmer, Geert-Jan Creemers, Casper HJ Van Eijck, Bas Groot Koerkamp, Marco J Bruno, Ferry Eskens, Joost J Nuyttens, Chulja Pek, George P Van der Schelling, Tom C Seerden, Gijs A Patijn, Vincent B Nieuwenhuijs, Jan W De Groot, Bert A Bonsing, Alexander Vahrmeijer, Rutger J Swijnenburg, J Sven D Mieog, Erwin Van der Harst, Marcel Den Dulk, Steven Olde Damink, Cees HC Dejong, Ronald Van Dam, Judith MPGM De Vos, Mike SL Liem, Cees JHM Van Laarhoven, Harry Van Goor, Peter B Van den Boezem, B Marion Van der Kolk, Martijn WJ Stommel, John J Hermans, Erwin JM Van Geenen, Sandra A Radema, Lodewijk A Brosens, Joris JG Scheepers, Daphne Roos, Djamilla Boerma, Wouter Te Riele, Hjalmar C Van Santvoort, Thomas L Bollen, Fanny Wit, I Quintus Molenaar, Nadia Haj Mohammad, Maarten S Van Leeuwen, Annemarie Roele, Kees P De Jong, Vincent E De Meijer, Joost M Klaase, Geert Kazemier, Babs Zonderhuis, Freek Daams, Martijn R Meijerink, Anouk Latenstein, L Bengt Van Rijssen, Carolijn Nota, Emo Van Halsema, Eran Van Veldhuisen, Jantien Vogel, Kiki Janssen, Lianne Scholten, Lois Daamen, Marieke Walma, Marin Strijker, Mariska Prins, Maurice Zwart, Mustafa Suker, Steffi Rombouts, Timothy Mungroop, Frederique Vissers, Maarten Korrel |
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| Přispěvatelé: | CCA - Cancer Treatment and quality of life, Surgery, Amsterdam Gastroenterology Endocrinology Metabolism, Graduate School, AGEM - Digestive immunity, AGEM - Endocrinology, metabolism and nutrition, AGEM - Re-generation and cancer of the digestive system, CCA - Cancer Treatment and Quality of Life, APH - Methodology, Epidemiology and Data Science, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, Oncology, Center of Experimental and Molecular Medicine, Radiotherapy, Pathology, Radiology and Nuclear Medicine, Ear, Nose and Throat, Epidemiology, Gastroenterology & Hepatology, Medical Oncology, Erasmus MC other, Radiology & Nuclear Medicine, Groningen Institute for Organ Transplantation (GIOT), Center for Liver, Digestive and Metabolic Diseases (CLDM), Value, Affordability and Sustainability (VALUE) |
| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Funding grant Other Research Radboud Institute for Molecular Life Sciences [Radboudumc 0] Pancreaticoduodenectomy law.invention Pancreatic Fistula 03 medical and health sciences Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14] Postoperative Complications 0302 clinical medicine Intravenous fluid Randomized controlled trial law Internal medicine Journal Article medicine Humans Aged Netherlands Surgeons Hepatology business.industry Gastroenterology Recovery of Function Middle Aged medicine.disease Functional recovery Surgery Pancreatic Neoplasms Clinical trial Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10] Editorial Commentary Treatment Outcome Pancreatic fistula 030220 oncology & carcinogenesis Relative risk Preoperative Period Female Laparoscopy 030211 gastroenterology & hepatology business |
| Zdroj: | Lancet Gastroenterology & Hepatology, 4, 3, pp. 199-207 The Lancet Gastroenterology and Hepatology, 4(3), 199-207. Elsevier Ltd Lancet Gastroenterology & Hepatology, 4, 199-207 lancet. Gastroenterology & hepatology, 4(3), 199-207. Elsevier Limited The Lancet Gastroenterology and Hepatology, 4(3), 199. Elsevier Limited van Hilst, J, de Rooij, T, Bosscha, K, Brinkman, D J, van Dieren, S, Dijkgraaf, M G, Gerhards, M F, de Hingh, I H, Karsten, T M, Lips, D J, Luyer, M D, Busch, O R, Festen, S, Besselink, M G, Marsman, H A, van Gulik, T M, Wicherts, D A, Eshuis, W J, Stibbe, L A, Nieveen van Dijkum, E J M, van Hooft, J E, Fockens, P, van Laarhoven, H W, Wilmink, J W, van de Vijver, M J, Bijlsma, M F, Verheij, J, Nio, C Y, van Lienden, K P, van Tienhoven, G, Schoorlemmer, A, Creemers, G-J, van Eijck, C H J, Groot Koerkamp, B, Bruno, M J, Eskens, F, Nuyttens, J J, Pek, C, van der Schelling, G P, Seerden, T C, de Groot, J W, Swijnenburg, R J, van den Boezem, P B, van Geenen, E J M, Scheepers, J J G, Kazemier, G, Zonderhuis, B, Daams, F, Meijerink, M R, Rombouts, S, Dutch Pancreatic Cancer Group, Mungroop, T H, Vissers, F & Korrel, M 2019, ' Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours (LEOPARD-2): a multicentre, patient-blinded, randomised controlled phase 2/3 trial ', The Lancet Gastroenterology and Hepatology, vol. 4, no. 3, pp. 199-207 . https://doi.org/10.1016/S2468-1253(19)30004-4 The Lancet Gastroenterology and Hepatology, 4(3), 199-207. Elsevier Ltd. The Lancet Gastroenterology and Hepatology, 4(3), 199-207. HANLEY & BELFUS-ELSEVIER INC |
| ISSN: | 2468-1253 |
| Popis: | Item does not contain fulltext BACKGROUND: Laparoscopic pancreatoduodenectomy may improve postoperative recovery compared with open pancreatoduodenectomy. However, there are concerns that the extensive learning curve of this complex procedure could increase the risk of complications. We aimed to assess whether laparoscopic pancreatoduodenectomy could reduce time to functional recovery compared with open pancreatoduodenectomy. METHODS: This multicentre, patient-blinded, parallel-group, randomised controlled phase 2/3 trial was performed in four centres in the Netherlands that each do 20 or more pancreatoduodenectomies annually; surgeons had to have completed a dedicated training programme for laparoscopic pancreatoduodenectomy and have done 20 or more laparoscopic pancreatoduodenectomies before trial participation. Patients with a benign, premalignant, or malignant indication for pancreatoduodenectomy, without signs of vascular involvement, were randomly assigned (1:1) to undergo either laparoscopic or open pancreatoduodenectomy using a central web-based system. Randomisation was stratified for annual case volume and preoperative estimated risk of pancreatic fistula. Patients were blinded to treatment allocation. Analysis was done according to the intention-to-treat principle. The main objective of the phase 2 part of the trial was to assess the safety of laparoscopic pancreatoduodenectomy (complications and mortality), and the primary outcome of phase 3 was time to functional recovery in days, defined as all of the following: adequate pain control with only oral analgesia; independent mobility; ability to maintain more than 50% of the daily required caloric intake; no need for intravenous fluid administration; and no signs of infection (temperature |
| Databáze: | OpenAIRE |
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