Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial.

Autor: van Hilst J; Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands., Korrel M; Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands., Lof S; Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands.; Department of General Surgery, Instituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy., de Rooij T; Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands., Vissers F; Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands., Al-Sarireh B; Department of Surgery, Morriston Hospital, Swansea, UK., Alseidi A; Department of Surgery, Virginia Mason Medical Center, Seattle, USA., Bateman AC; Department of Cellular Pathology, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Björnsson B; Department of Surgery in Linköping and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden., Boggi U; Department of Surgery, Universitá di Pisa, Pisa, Italy., Bratlie SO; Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden., Busch O; Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands., Butturini G; Department of Surgery, Pederzoli Hospital, Peschiera, Italy., Casadei R; Division of Pancreatic Surgery IRCCS, Azienda Ospedaliero Universitaria Department of Internal Medicine and Surgery (DIMEC), S. Orsola-Malpighi Hospital, Alma Mater Studiorum, University of Bologna, Bologna, Italy., Dijk F; Department of Pathology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands., Dokmak S; Department of HPB surgery and liver transplantation, Beaujon Hospital, Clichy, France., Edwin B; Department of Surgery, Oslo University Hospital and Institute for Clinical Medicine, Oslo, Norway., van Eijck C; Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands., Esposito A; Department of General and Pancreatic Surgery - Pancreas Institute, University Hospital of Verona, Verona, Italy., Fabre JM; Department of Surgery, Hopital Saint Eloi, Montpellier, France., Falconi M; Department of Surgery, San Raffaele Hospital IRCCS, Università Vita-Salute, Milan, Italy., Ferrari G; Department of Surgery, Niguarda Ca'Granda Hospital, Milan, Italy., Fuks D; Department of Surgery, Institut Mutualiste Montsouris, Paris, France., Groot Koerkamp B; Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands., Hackert T; Department of Surgery, Heidelberg University Hospital, Heidelberg, Germany., Keck T; Department of Surgery, UKSH campus Lübeck, Lübeck, Germany., Khatkov I; Department of Surgery, Moscow Clinical Scientific Center, Moscow, Russian Federation., de Kleine R; Department of Surgery, University Medical Center Groningen, Groningen, the Netherlands., Kokkola A; Department of Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Kooby DA; Department of Surgery, Emory University Hospital, Atlanta, USA., Lips D; Department of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands., Luyer M; Department of Surgery, Catharina Ziekenhuis, Eindhoven, the Netherlands., Marudanayagam R; Department of HPB Surgery, University Hospital Birmingham, Birmingham, UK., Menon K; Department of Surgery, King's College Hospital NHS Foundation Trust, London, UK., Molenaar Q; Department of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands., de Pastena M; Department of General and Pancreatic Surgery - Pancreas Institute, University Hospital of Verona, Verona, Italy., Pietrabissa A; Department of Surgery, IRCCS Policlinico San Matteo Pavia, Pavia, Italy., Rajak R; Department of Surgery, Virginia Mason Medical Center, Seattle, USA., Rosso E; Department of General Surgery, Instituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy., Sanchez Velazquez P; Department of Surgery, Hospital del Mar, Barcelona, Spain., Saint Marc O; Department of Surgery, Centre Hospitalier Regional D'Orleans, Orleans, France., Shah M; Department of Surgery, Emory University Hospital, Atlanta, USA., Soonawalla Z; Department of Surgery, Oxford University Hospital NHS Foundation Trust, Oxford, UK., Tomazic A; Department of Surgery, University Medical Center Ljubljana, Ljubljana, Slovenia., Verbeke C; Department of Pathology, University of Oslo, Oslo, Norway., Verheij J; Department of Pathology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands., White S; Department of Surgery, The Freeman Hospital Newcastle Upon Tyne, Newcastle, UK., Wilmink HW; Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands., Zerbi A; Department of Surgery, Humanitas Clinical and Research Center-IRCCS, Rozzano (MI) and Humanitas University, Pieve Emanuele, MI, Italy., Dijkgraaf MG; Department of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Besselink MG; Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands. m.g.besselink@amsterdamUMC.nl., Abu Hilal M; Department of General Surgery, Instituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy. mohd.abuhilal@poliambulanza.it.; Department of General Surgery, Fondazione Poliambulanza Instituto Ospedaliero, Brescia, Italy. mohd.abuhilal@poliambulanza.it.
Jazyk: angličtina
Zdroj: Trials [Trials] 2021 Sep 09; Vol. 22 (1), pp. 608. Date of Electronic Publication: 2021 Sep 09.
DOI: 10.1186/s13063-021-05506-z
Abstrakt: 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.
(© 2021. The Author(s).)
Databáze: MEDLINE
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