Evidence map›Paper›PMID 34503548›Full record

ArticleTrials2021

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

Jony van Hilst, Maarten Korrel, Sanne Lof, Thijs de Rooij, Frederique Vissers, Bilal Al-Sarireh, Adnan Alseidi, Adrian C Bateman, Bergthor Björnsson, Ugo Boggi and 43 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 37 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

53 authors at 20 institutions in 12 countries.

Jony van HilstDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands.ORCID http://orcid.org/0000-0003-4990-445X
Maarten Korrel *Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands.
Sanne Lof *Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands.
Thijs de Rooij *Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands.
Frederique VissersDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands.
Bilal Al-SarirehDepartment of Surgery, Morriston Hospital, Swansea, UK.
Adnan AlseidiDepartment of Surgery, Virginia Mason Medical Center, Seattle, USA.
Adrian C BatemanDepartment of Cellular Pathology, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Bergthor BjörnssonDepartment of Surgery in Linköping and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Ugo BoggiDepartment of Surgery, Universitá di Pisa, Pisa, Italy.
Svein Olav BratlieDepartment of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
Olivier BuschDepartment of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, VUMC, ZH-7F18, PO Box 7057, 1007 MB, Amsterdam, the Netherlands.
Giovanni ButturiniDepartment of Surgery, Pederzoli Hospital, Peschiera, Italy.
Riccardo CasadeiDivision 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.
Frederike DijkDepartment of Pathology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.
Safi DokmakDepartment of HPB surgery and liver transplantation, Beaujon Hospital, Clichy, France.
Bjorn EdwinDepartment of Surgery, Oslo University Hospital and Institute for Clinical Medicine, Oslo, Norway.
Casper van EijckDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Alessandro EspositoDepartment of General and Pancreatic Surgery - Pancreas Institute, University Hospital of Verona, Verona, Italy.
Jean-Michel FabreDepartment of Surgery, Hopital Saint Eloi, Montpellier, France.
Massimo FalconiDepartment of Surgery, San Raffaele Hospital IRCCS, Università Vita-Salute, Milan, Italy.
Giovanni FerrariDepartment of Surgery, Niguarda Ca'Granda Hospital, Milan, Italy.
David FuksDepartment of Surgery, Institut Mutualiste Montsouris, Paris, France.
Bas Groot KoerkampDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Thilo HackertDepartment of Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Tobias KeckDepartment of Surgery, UKSH campus Lübeck, Lübeck, Germany.
Igor KhatkovDepartment of Surgery, Moscow Clinical Scientific Center, Moscow, Russian Federation.
Ruben de KleineDepartment of Surgery, University Medical Center Groningen, Groningen, the Netherlands.
Arto KokkolaDepartment of Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
David A KoobyDepartment of Surgery, Emory University Hospital, Atlanta, USA.
Daan LipsDepartment of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands.
Misha LuyerDepartment of Surgery, Catharina Ziekenhuis, Eindhoven, the Netherlands.
Ravi MarudanayagamDepartment of HPB Surgery, University Hospital Birmingham, Birmingham, UK.
Krishna MenonDepartment of Surgery, King's College Hospital NHS Foundation Trust, London, UK.
Quintus MolenaarDepartment of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands.
Matteo de PastenaDepartment of General and Pancreatic Surgery - Pancreas Institute, University Hospital of Verona, Verona, Italy.
Andrea PietrabissaDepartment of Surgery, IRCCS Policlinico San Matteo Pavia, Pavia, Italy.
Rushda RajakDepartment of Surgery, Virginia Mason Medical Center, Seattle, USA.
Edoardo RossoDepartment of General Surgery, Instituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy.
Patricia Sanchez VelazquezDepartment of Surgery, Hospital del Mar, Barcelona, Spain.
Olivier Saint MarcDepartment of Surgery, Centre Hospitalier Regional D'Orleans, Orleans, France.
Mihir ShahDepartment of Surgery, Emory University Hospital, Atlanta, USA.
Zahir SoonawallaDepartment of Surgery, Oxford University Hospital NHS Foundation Trust, Oxford, UK.
Ales TomazicDepartment of Surgery, University Medical Center Ljubljana, Ljubljana, Slovenia.
Caroline VerbekeDepartment of Pathology, University of Oslo, Oslo, Norway.
Joanne VerheijDepartment of Pathology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.
Steven WhiteDepartment of Surgery, The Freeman Hospital Newcastle Upon Tyne, Newcastle, UK.
Hanneke W WilminkDepartment of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.
Alessandro ZerbiDepartment of Surgery, Humanitas Clinical and Research Center-IRCCS, Rozzano (MI) and Humanitas University, Pieve Emanuele, MI, Italy.
Marcel G DijkgraafDepartment of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Marc G Besselink *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.
Mohammad Abu Hilal *Department of General Surgery, Instituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy. mohd.abuhilal@poliambulanza.it.
European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS)
Amsterdam University Medical Centers · NLFondazione Poliambulanza Istituto Ospedaliero · ITEmory University Hospital · USErasmus MC Cancer Institute · NLUniversity of Verona · ITVirginia Mason Medical Center · USAmsterdam Neuroscience · NLAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITCentre hospitalier universitaire d'Orléans · FRFreeman Hospital · GBHeidelberg University · DEHôpital Beaujon · FRHôpital Saint Eloi · FRHospital Del Mar · ESHumanitas University · ITInstitute Mutualiste Montsouris · FRIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITKing's College Hospital NHS Foundation Trust · GBLinköping University · SELjubljana University Medical Centre · SI

Funding

Covidien ISR-2017-10928
6 · The paper itself

Abstract

backgroundRecently, 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/

designDIPLOMA 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 registrationISRCTN registry ISRCTN44897265 . Prospectively registered on 16 April 2018.

Indexed as

Carcinoma, Pancreatic DuctalLaparoscopyPancreatic NeoplasmsEquivalence Trials as TopicHumansPancreatectomyPostoperative ComplicationsQuality of LifeRandomized Controlled Trials as TopicRetrospective StudiesTreatment OutcomeDistal pancreatectomyLaparoscopicLeft pancreatectomyMinimally invasivePancreatic cancerPancreatic ductal adenocarcinomaPancreatic surgeryPancreatic tail resectionRobot-assisted

Identifiers

PMID34503548
PMCPMC8427847
OpenAlexW3197260768

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.