Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial

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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 (författare): Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, iTALY; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands

Emmen, Anouk M. L. H. (författare): Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, iTALY; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands

Ramera, Marco (författare): Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy

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Björnsson, Bergthor, 1975- (författare): Linköpings universitet,Medicinska fakulteten,Avdelningen för kirurgi, ortopedi och onkologi,Region Östergötland, Kirurgiska kliniken US

Boggi, Ugo (författare): Department of Surgery, Universitá Di Pisa, Pisa, Italy

Bruna, Caro L. (författare): Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, iTALY; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands

Busch, Olivier R. (författare): Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands

Daams, Freek (författare): Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands

Ferrari, Giovanni (författare): Department of Surgery, Niguarda Ca’Granda Hospital, Milan, Italy

Festen, Sebastiaan (författare): Cancer Center Amsterdam, Amsterdam, Netherlands

van Hilst, Jony (författare): Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, NetherlandsDepartment of Surgery, OLVG, Amsterdam, Netherlands

D’Hondt, Mathieu (författare): Department of Surgery, AZ Groeninge, Kortrijk, Belgium

Ielpo, Benedetto (författare): Department of Surgery, Hospital del Mar, Barcelona, Spain

Keck, Tobias (författare): Department of Surgery, UKSH Campus Lübeck, Lübeck, Germany

Khatkov, Igor E. (författare): Department of Surgery, Moscow Clinical Scientific Center, Moscow, Russian Federation

Koerkamp, Bas Groot (författare): Department of Surgery, Erasmus MC, Rotterdam, Netherlands

Lips, Daan J. (författare): Department of Surgery, Medisch Spectrum Twente, Enschede, Netherlands

Luyer, Misha D. P. (författare): Department of Surgery, Catharina Ziekenhuis, Eindhoven, Netherlands

Mieog, J. Sven D. (författare): Department of Surgery, Leiden University Medical Center, Leiden, Netherlands

Morelli, Luca (författare): General Surgery Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy

Molenaar, I. Quintus (författare): Department of Surgery, University Medical Center Utrecht, Utrecht, Netherlands; Department of Surgery, St. Antonius Hospital, Nieuwegein, Netherlands

van Santvoort, Hjalmar C. (författare): Department of Surgery, University Medical Center Utrecht, Utrecht, Netherlands; Department of Surgery, St. Antonius Hospital, Nieuwegein, Netherlands

Sprangers, Mirjam A. G. (författare): Department of Medical Psychology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands

Ferrari, Clarissa (författare): Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, 25123, Italy

Berkhof, Johannes (författare): Department of Epidemiology and Data Science, Amsterdam UMC, VU University, Amsterdam, Netherlands

Maisonneuve, Patrick (författare): Division of Epidemiology and Biostatistics, IEO European Institute of Oncology IRCCS, Milan, Italy

Abu Hilal, Mohammad (författare): Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, 25123, Italy

Besselink, Marc G. (författare): Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands

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BioMed Central Ltd, 2023
2023
Engelska.
Ingår i: Trials. - : BioMed Central Ltd. - 1745-6215. ; 24:1

Relaterad länk:: https://urn.kb.se/re...; visa fler...; https://doi.org/10.1...; visa färre...

Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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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-β), 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. © 2023, BioMed Central Ltd., part of Springer Nature.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)

Nyckelord

Humans; Laparoscopy; Multicenter Studies as Topic; Pancreas; Pancreatic Neoplasms; Pancreaticoduodenectomy; Postoperative Complications; Quality of Life; Randomized Controlled Trials as Topic; Retrospective Studies; Article; clinical effectiveness; comparative effectiveness; controlled study; conversion to open surgery; elective surgery; health care cost; hospital readmission; human; laparoscopic surgery; length of stay; major clinical study; minimally invasive surgery; multicenter study; open surgery; operation duration; outcome assessment; pancreas cancer; pancreaticoduodenectomy; patient safety; postoperative hemorrhage; quality of life; randomized controlled trial; robot assisted surgery; surgical approach; surgical technique; treatment indication; Vater papilla carcinoma; laparoscopy; multicenter study (topic); pancreas; pancreas tumor; pancreaticoduodenectomy; pathology; postoperative complication; procedures; randomized controlled trial (topic); retrospective study

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Kirurgi

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