Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial
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 adenoca...
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BMC
2021-09-01
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Series: | Trials |
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Online Access: | https://doi.org/10.1186/s13063-021-05506-z |
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collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Jony van Hilst Maarten Korrel Sanne Lof Thijs de Rooij Frederique Vissers Bilal Al-Sarireh Adnan Alseidi Adrian C. Bateman Bergthor Björnsson Ugo Boggi Svein Olav Bratlie Olivier Busch Giovanni Butturini Riccardo Casadei Frederike Dijk Safi Dokmak Bjorn Edwin Casper van Eijck Alessandro Esposito Jean-Michel Fabre Massimo Falconi Giovanni Ferrari David Fuks Bas Groot Koerkamp Thilo Hackert Tobias Keck Igor Khatkov Ruben de Kleine Arto Kokkola David A. Kooby Daan Lips Misha Luyer Ravi Marudanayagam Krishna Menon Quintus Molenaar Matteo de Pastena Andrea Pietrabissa Rushda Rajak Edoardo Rosso Patricia Sanchez Velazquez Olivier Saint Marc Mihir Shah Zahir Soonawalla Ales Tomazic Caroline Verbeke Joanne Verheij Steven White Hanneke W. Wilmink Alessandro Zerbi Marcel G. Dijkgraaf Marc G. Besselink Mohammad Abu Hilal for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) |
spellingShingle |
Jony van Hilst Maarten Korrel Sanne Lof Thijs de Rooij Frederique Vissers Bilal Al-Sarireh Adnan Alseidi Adrian C. Bateman Bergthor Björnsson Ugo Boggi Svein Olav Bratlie Olivier Busch Giovanni Butturini Riccardo Casadei Frederike Dijk Safi Dokmak Bjorn Edwin Casper van Eijck Alessandro Esposito Jean-Michel Fabre Massimo Falconi Giovanni Ferrari David Fuks Bas Groot Koerkamp Thilo Hackert Tobias Keck Igor Khatkov Ruben de Kleine Arto Kokkola David A. Kooby Daan Lips Misha Luyer Ravi Marudanayagam Krishna Menon Quintus Molenaar Matteo de Pastena Andrea Pietrabissa Rushda Rajak Edoardo Rosso Patricia Sanchez Velazquez Olivier Saint Marc Mihir Shah Zahir Soonawalla Ales Tomazic Caroline Verbeke Joanne Verheij Steven White Hanneke W. Wilmink Alessandro Zerbi Marcel G. Dijkgraaf Marc G. Besselink Mohammad Abu Hilal for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial Trials Minimally invasive Laparoscopic Robot-assisted Distal pancreatectomy Left pancreatectomy Pancreatic tail resection |
author_facet |
Jony van Hilst Maarten Korrel Sanne Lof Thijs de Rooij Frederique Vissers Bilal Al-Sarireh Adnan Alseidi Adrian C. Bateman Bergthor Björnsson Ugo Boggi Svein Olav Bratlie Olivier Busch Giovanni Butturini Riccardo Casadei Frederike Dijk Safi Dokmak Bjorn Edwin Casper van Eijck Alessandro Esposito Jean-Michel Fabre Massimo Falconi Giovanni Ferrari David Fuks Bas Groot Koerkamp Thilo Hackert Tobias Keck Igor Khatkov Ruben de Kleine Arto Kokkola David A. Kooby Daan Lips Misha Luyer Ravi Marudanayagam Krishna Menon Quintus Molenaar Matteo de Pastena Andrea Pietrabissa Rushda Rajak Edoardo Rosso Patricia Sanchez Velazquez Olivier Saint Marc Mihir Shah Zahir Soonawalla Ales Tomazic Caroline Verbeke Joanne Verheij Steven White Hanneke W. Wilmink Alessandro Zerbi Marcel G. Dijkgraaf Marc G. Besselink Mohammad Abu Hilal for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) |
author_sort |
Jony van Hilst |
title |
Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial |
title_short |
Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial |
title_full |
Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial |
title_fullStr |
Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial |
title_full_unstemmed |
Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial |
title_sort |
minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (diploma): study protocol for a randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2021-09-01 |
description |
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. |
topic |
Minimally invasive Laparoscopic Robot-assisted Distal pancreatectomy Left pancreatectomy Pancreatic tail resection |
url |
https://doi.org/10.1186/s13063-021-05506-z |
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doaj-fc4c58845c334f1494322a43a95bbe1d2021-09-12T11:34:01ZengBMCTrials1745-62152021-09-0122111110.1186/s13063-021-05506-zMinimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trialJony van Hilst0Maarten Korrel1Sanne Lof2Thijs de Rooij3Frederique Vissers4Bilal Al-Sarireh5Adnan Alseidi6Adrian C. Bateman7Bergthor Björnsson8Ugo Boggi9Svein Olav Bratlie10Olivier Busch11Giovanni Butturini12Riccardo Casadei13Frederike Dijk14Safi Dokmak15Bjorn Edwin16Casper van Eijck17Alessandro Esposito18Jean-Michel Fabre19Massimo Falconi20Giovanni Ferrari21David Fuks22Bas Groot Koerkamp23Thilo Hackert24Tobias Keck25Igor Khatkov26Ruben de Kleine27Arto Kokkola28David A. Kooby29Daan Lips30Misha Luyer31Ravi Marudanayagam32Krishna Menon33Quintus Molenaar34Matteo de Pastena35Andrea Pietrabissa36Rushda Rajak37Edoardo Rosso38Patricia Sanchez Velazquez39Olivier Saint Marc40Mihir Shah41Zahir Soonawalla42Ales Tomazic43Caroline Verbeke44Joanne Verheij45Steven White46Hanneke W. Wilmink47Alessandro Zerbi48Marcel G. Dijkgraaf49Marc G. Besselink50Mohammad Abu Hilal51for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS)Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center AmsterdamDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center AmsterdamDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center AmsterdamDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center AmsterdamDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center AmsterdamDepartment of Surgery, Morriston HospitalDepartment of Surgery, Virginia Mason Medical CenterDepartment of Cellular Pathology, University Hospital Southampton NHS Foundation TrustDepartment of Surgery in Linköping and Department of Biomedical and Clinical Sciences, Linköping UniversityDepartment of Surgery, Universitá di PisaDepartment of Surgery, Sahlgrenska University HospitalDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center AmsterdamDepartment of Surgery, Pederzoli HospitalDivision of Pancreatic Surgery IRCCS, Azienda Ospedaliero Universitaria Department of Internal Medicine and Surgery (DIMEC), S. Orsola-Malpighi Hospital, Alma Mater Studiorum, University of BolognaDepartment of Pathology, Cancer Center Amsterdam, Amsterdam UMCDepartment of HPB surgery and liver transplantation, Beaujon HospitalDepartment of Surgery, Oslo University Hospital and Institute for Clinical MedicineDepartment of Surgery, Erasmus MC Cancer InstituteDepartment of General and Pancreatic Surgery - Pancreas Institute, University Hospital of VeronaDepartment of Surgery, Hopital Saint EloiDepartment of Surgery, San Raffaele Hospital IRCCS, Università Vita-SaluteDepartment of Surgery, Niguarda Ca’Granda HospitalDepartment of Surgery, Institut Mutualiste MontsourisDepartment of Surgery, Erasmus MC Cancer InstituteDepartment of Surgery, Heidelberg University HospitalDepartment of Surgery, UKSH campus LübeckDepartment of Surgery, Moscow Clinical Scientific CenterDepartment of Surgery, University Medical Center GroningenDepartment of Surgery, University of Helsinki and Helsinki University HospitalDepartment of Surgery, Emory University HospitalDepartment of Surgery, Medisch Spectrum TwenteDepartment of Surgery, Catharina ZiekenhuisDepartment of HPB Surgery, University Hospital BirminghamDepartment of Surgery, King’s College Hospital NHS Foundation TrustDepartment of Surgery, University Medical Center UtrechtDepartment of General and Pancreatic Surgery - Pancreas Institute, University Hospital of VeronaDepartment of Surgery, IRCCS Policlinico San Matteo PaviaDepartment of Surgery, Virginia Mason Medical CenterDepartment of General Surgery, Instituto Ospedaliero Fondazione PoliambulanzaDepartment of Surgery, Hospital del MarDepartment of Surgery, Centre Hospitalier Regional D’OrleansDepartment of Surgery, Emory University HospitalDepartment of Surgery, Oxford University Hospital NHS Foundation TrustDepartment of Surgery, University Medical Center LjubljanaDepartment of Pathology, University of OsloDepartment of Pathology, Cancer Center Amsterdam, Amsterdam UMCDepartment of Surgery, The Freeman Hospital Newcastle Upon TyneDepartment of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMCDepartment of Surgery, Humanitas Clinical and Research Center-IRCCS, Rozzano (MI) and Humanitas UniversityDepartment of Epidemiology and Data Science, Amsterdam UMC, University of AmsterdamDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center AmsterdamDepartment of General Surgery, Instituto Ospedaliero Fondazione PoliambulanzaAbstract 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.https://doi.org/10.1186/s13063-021-05506-zMinimally invasiveLaparoscopicRobot-assistedDistal pancreatectomyLeft pancreatectomyPancreatic tail resection |