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Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial.
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.
Afiliación
  • de Graaf N; Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, 25123, Italy. n.degraaf@amsterdamUMC.nl.
  • Emmen AMLH; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, the Netherlands. n.degraaf@amsterdamUMC.nl.
  • Ramera M; Cancer Center Amsterdam, Amsterdam, the Netherlands. n.degraaf@amsterdamUMC.nl.
  • Björnsson B; Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, 25123, Italy.
  • Boggi U; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, the Netherlands.
  • Bruna CL; Cancer Center Amsterdam, Amsterdam, the Netherlands.
  • Busch OR; Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, 25123, Italy.
  • Daams F; Department of Surgery, Linköping University Hospital, Linköping, Sweden.
  • Ferrari G; Department of Surgery, Universitá Di Pisa, Pisa, Italy.
  • Festen S; Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, 25123, Italy.
  • van Hilst J; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, the Netherlands.
  • D'Hondt M; Cancer Center Amsterdam, Amsterdam, the Netherlands.
  • Ielpo B; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, the Netherlands.
  • Keck T; Cancer Center Amsterdam, Amsterdam, the Netherlands.
  • Khatkov IE; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, the Netherlands.
  • Koerkamp BG; Cancer Center Amsterdam, Amsterdam, the Netherlands.
  • Lips DJ; Department of Surgery, Niguarda Ca'Granda Hospital, Milan, Italy.
  • Luyer MDP; Cancer Center Amsterdam, Amsterdam, the Netherlands.
  • Mieog JSD; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, the Netherlands.
  • Morelli L; Cancer Center Amsterdam, Amsterdam, the Netherlands.
  • Molenaar IQ; Department of Surgery, OLVG, Amsterdam, the Netherlands.
  • van Santvoort HC; Department of Surgery, AZ Groeninge, Kortrijk, Belgium.
  • Sprangers MAG; Department of Surgery, Hospital del Mar, Barcelona, Spain.
  • Ferrari C; Department of Surgery, UKSH Campus Lübeck, Lübeck, Germany.
  • Berkhof J; Department of Surgery, Moscow Clinical Scientific Center, Moscow, Russian Federation.
  • Maisonneuve P; Department of Surgery, Erasmus MC, Rotterdam, the Netherlands.
  • Abu Hilal M; Department of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands.
  • Besselink MG; Department of Surgery, Catharina Ziekenhuis, Eindhoven, the Netherlands.
Trials ; 24(1): 665, 2023 Oct 12.
Article en En | MEDLINE | ID: mdl-37828593
BACKGROUND: Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. METHODS/DESIGN: The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-ß), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. DISCUSSION: The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. TRIAL REGISTRATION: ISRCTN27483786. Registered on August 2, 2023.
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Neoplasias Pancreáticas / Laparoscopía Límite: Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: Italia

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Neoplasias Pancreáticas / Laparoscopía Límite: Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: Italia