Evidence map›Paper›PMID 28388963›Full record

Trial reportTrials2017

Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial.

Thijs de Rooij, Jony van Hilst, Jantien A Vogel, Hjalmar C van Santvoort, Marieke T de Boer, Djamila Boerma, Peter B van den Boezem, Bert A Bonsing, Koop Bosscha, Peter-Paul Coene and 30 more

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Optimizing the outcomes of pancreatic cancer surgery.Nature reviews. Clinical oncology · 2019
    Review
  15. Review
  16. Article
  17. Article
  18. Laparoscopic distal pancreatectomy: better than open?Translational gastroenterology and hepatology · 2018
    Review
  19. Article
  20. Is there any role for minimally invasive surgery in NET?Reviews in endocrine & metabolic disorders · 2017
    Review
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

40 authors at 13 institutions in 3 countries.

Thijs de RooijDepartment of Surgery, Academic Medical Center, PO Box 22660, Amsterdam, AZ 1105, The Netherlands.
Jony van HilstDepartment of Surgery, Academic Medical Center, PO Box 22660, Amsterdam, AZ 1105, The Netherlands.
Jantien A VogelDepartment of Surgery, Academic Medical Center, PO Box 22660, Amsterdam, AZ 1105, The Netherlands.
Hjalmar C van SantvoortDepartment of Surgery, St Antonius Hospital, PO Box 2500, Nieuwegein, EM 3430, The Netherlands.
Marieke T de BoerDepartment of Surgery, University Medical Center Groningen, PO Box 30 001, Groningen, RB 9700, The Netherlands.
Djamila BoermaDepartment of Surgery, St Antonius Hospital, PO Box 2500, Nieuwegein, EM 3430, The Netherlands.
Peter B van den BoezemDepartment of Surgery, Radboud University Nijmegen Medical Center, PO Box 9101, Nijmegen, HB 6500, The Netherlands.
Bert A BonsingDepartment of Surgery, Leiden University Medical Center, PO Box 9600, Leiden, ZA 2333, The Netherlands.
Koop BosschaDepartment of Surgery, Jeroen Bosch Hospital, PO Box 90153, Den Bosch, ME 5200, The Netherlands.
Peter-Paul CoeneDepartment of Surgery, Maasstad Hospital, PO Box 9100, Rotterdam, AC 3007, The Netherlands.
Freek DaamsDepartment of Surgery, VU University Medical Center, PO Box 7057, Amsterdam, HV 1081, The Netherlands.
Ronald M van DamDepartment of Surgery, Maastricht University Medical Center, PO Box 5800, Maastricht, AZ 6202, The Netherlands.
Marcel G DijkgraafClinical Research Unit, Academic Medical Center, PO Box 22660, Amsterdam, DD 1100, The Netherlands.
Casper H van EijckDepartment of Surgery, Erasmus University Medical Center, PO Box 2040, Rotterdam, CA 3000, The Netherlands.
Sebastiaan FestenDepartment of Surgery, Onze Lieve Vrouwe Gasthuis, PO Box 95500, Amsterdam, HM 1090, The Netherlands.
Michael F GerhardsDepartment of Surgery, Onze Lieve Vrouwe Gasthuis, PO Box 95500, Amsterdam, HM 1090, The Netherlands.
Bas Groot KoerkampDepartment of Surgery, Erasmus University Medical Center, PO Box 2040, Rotterdam, CA 3000, The Netherlands.
Jeroen HagendoornDepartment of Surgery, University Medical Center Utrecht, PO Box 85 500, Utrecht, GA 3508, The Netherlands.
Erwin van der HarstDepartment of Surgery, Maasstad Hospital, PO Box 9100, Rotterdam, AC 3007, The Netherlands.
Ignace H de HinghDepartment of Surgery, Catharina Hospital, PO Box 1350, Eindhoven, ZA 5602, The Netherlands.
Cees H DejongDepartment of Surgery, Maastricht University Medical Center, PO Box 5800, Maastricht, AZ 6202, The Netherlands.
Geert KazemierDepartment of Surgery, VU University Medical Center, PO Box 7057, Amsterdam, HV 1081, The Netherlands.
Joost KlaaseDepartment of Surgery, Medisch Spectrum Twente, PO Box 50 000, Enschede, KA 7500, The Netherlands.
Ruben H de KleineDepartment of Surgery, University Medical Center Groningen, PO Box 30 001, Groningen, RB 9700, The Netherlands.
Cornelis J van LaarhovenDepartment of Surgery, Radboud University Nijmegen Medical Center, PO Box 9101, Nijmegen, HB 6500, The Netherlands.
Daan J LipsDepartment of Surgery, Jeroen Bosch Hospital, PO Box 90153, Den Bosch, ME 5200, The Netherlands.
Misha D LuyerDepartment of Surgery, Catharina Hospital, PO Box 1350, Eindhoven, ZA 5602, The Netherlands.
I Quintus MolenaarDepartment of Surgery, University Medical Center Utrecht, PO Box 85 500, Utrecht, GA 3508, The Netherlands.
Vincent B NieuwenhuijsDepartment of Surgery, Isala Clinics, PO Box 10 400, Zwolle, AB 8025, The Netherlands.
Gijs A PatijnDepartment of Surgery, Isala Clinics, PO Box 10 400, Zwolle, AB 8025, The Netherlands.
Daphne RoosDepartment of Surgery, Reinier de Graag Gasthuis, PO Box 5011, Delft, GA 2600, The Netherlands.
Joris J ScheepersDepartment of Surgery, Reinier de Graag Gasthuis, PO Box 5011, Delft, GA 2600, The Netherlands.
George P van der SchellingDepartment of Surgery, Amphia Hospital, PO Box 90 158, Breda, RK 4800, The Netherlands.
Pascal SteenvoordeDepartment of Surgery, Medisch Spectrum Twente, PO Box 50 000, Enschede, KA 7500, The Netherlands.
Rutger-Jan SwijnenburgDepartment of Surgery, Leiden University Medical Center, PO Box 9600, Leiden, ZA 2333, The Netherlands.
Jan H WijsmanDepartment of Surgery, Amphia Hospital, PO Box 90 158, Breda, RK 4800, The Netherlands.
Moh'd Abu HilalDepartment of Surgery, Southampton University Hospital NHS Foundation Trust, Southampton, SO166YD, UK.
Olivier R BuschDepartment of Surgery, Academic Medical Center, PO Box 22660, Amsterdam, DD 1100, The Netherlands.
Marc G BesselinkDepartment of Surgery, Academic Medical Center, PO Box 22660, Amsterdam, DD 1100, The Netherlands. m.g.besselink@amc.nl.
Dutch Pancreatic Cancer Group
Amsterdam UMC Location University of Amsterdam · NLRadboud University Nijmegen · NLErasmus MC · NLUniversity Medical Center Groningen · NLLeiden University Medical Center · NLReinier de Graaf Hospital · NLUniversity Medical Center · USMaasstad Ziekenhuis · NLMedisch Spectrum Twente · NLUniversity Medical Center Utrecht · NLIsala · NLOLVG · NLUniversity Hospital Southampton NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundObservational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting.

methodsLEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs. DISCUSSION: The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting.

trial registrationDutch Trial Register, NTR5188 . Registered on 9 April 2015.

Indexed as

LaparoscopyRobotic Surgical ProceduresAdministration, OralAnalgesicsClinical ProtocolsCost-Benefit AnalysisEatingEnergy IntakeHealth StatusHospital CostsHumansNetherlandsPain MeasurementPancreatectomyPostoperative PainQuality of LifeAnalgesicsDistal pancreatectomyLaparoscopicMinimally invasivePancreatic cancerPancreatic surgeryRobot-assisted

Identifiers

PMID28388963
PMCPMC5385082
OpenAlexW2604505885

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Registered trials

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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.