Evidence map›Paper›PMID 29298706›Full record

ArticleTrials2018

Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial.

Thijs de Rooij, Jony van Hilst, Koop Bosscha, Marcel G Dijkgraaf, Michael F Gerhards, Bas Groot Koerkamp, Jeroen Hagendoorn, Ignace H de Hingh, Tom M Karsten, Daan J Lips and 8 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

26 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  19. [Evidence in minimally invasive surgery of the pancreas].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2021
    Review
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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

18 authors.

Thijs de RooijDepartment of Surgery, Academic Medical Center, Cancer Center Amsterdam, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
Jony van HilstDepartment of Surgery, Academic Medical Center, Cancer Center Amsterdam, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
Koop BosschaDepartment of Surgery, Jeroen Bosch Hospital, PO Box 90153, 5200 ME, Den Bosch, The Netherlands.
Marcel G DijkgraafClinical Research Unit, Academic Medical Center, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
Michael F GerhardsDepartment of Surgery, Onze Lieve Vrouwe Gasthuis, PO Box 95500, 1090 HM, Amsterdam, The Netherlands.
Bas Groot KoerkampDepartment of Surgery, Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands.
Jeroen HagendoornDepartment of Surgery, University Medical Center Utrecht, PO Box 85 500, 3508 GA, Utrecht, The Netherlands.
Ignace H de HinghDepartment of Surgery, Catharina Hospital, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
Tom M KarstenDepartment of Surgery, Onze Lieve Vrouwe Gasthuis, PO Box 95500, 1090 HM, Amsterdam, The Netherlands.
Daan J LipsDepartment of Surgery, Jeroen Bosch Hospital, PO Box 90153, 5200 ME, Den Bosch, The Netherlands.
Misha D LuyerDepartment of Surgery, Catharina Hospital, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
I Quintus MolenaarDepartment of Surgery, University Medical Center Utrecht, PO Box 85 500, 3508 GA, Utrecht, The Netherlands.
Hjalmar C van SantvoortDepartment of Surgery, Academic Medical Center, Cancer Center Amsterdam, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
T C Khé TranDepartment of Surgery, Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands.
Olivier R BuschDepartment of Surgery, Academic Medical Center, Cancer Center Amsterdam, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
Sebastiaan FestenDepartment of Surgery, Onze Lieve Vrouwe Gasthuis, PO Box 95500, 1090 HM, Amsterdam, The Netherlands.
Marc G BesselinkDepartment of Surgery, Academic Medical Center, Cancer Center Amsterdam, PO Box 22660, 1100 DD, Amsterdam, The Netherlands. m.g.besselink@amc.nl.
Dutch Pancreatic Cancer Group

Funding

Ethicon Endo-Surgery IIS 15-707
6 · The paper itself

Abstract

backgroundData from observational studies suggest that minimally invasive pancreatoduodenectomy (MIPD) is superior to open pancreatoduodenectomy regarding intraoperative blood loss, postoperative morbidity, and length of hospital stay, without increasing total costs. However, several case-matched studies failed to demonstrate superiority of MIPD, and large registry studies from the USA even suggested increased mortality for MIPDs performed in low-volume (<10 MIPDs annually) centers. Randomized controlled multicenter trials are lacking but clearly required. We hypothesize that time to functional recovery is shorter after MIPD compared with open pancreatoduodenectomy, even in an enhanced recovery setting. METHODS/

designLEOPARD-2 is a randomized controlled, parallel-group, patient-blinded, multicenter, phase 2/3, superiority trial in centers that completed the Dutch Pancreatic Cancer Group LAELAPS-2 training program for laparoscopic pancreatoduodenectomy or LAELAPS-3 training program for robot-assisted pancreatoduodenectomy and have performed ≥ 20 MIPDs. A total of 136 patients with symptomatic benign, premalignant, or malignant disease will be randomly assigned to undergo minimally invasive or open pancreatoduodenectomy in an enhanced recovery setting. After the first 40 patients (phase 2), the data safety monitoring board will assess safety outcomes (not blinded for treatment allocation) and decide on continuation to phase 3. Patients from phase 2 will then be included in phase 3. The primary outcome measure is time (days) to functional recovery. All patients will be blinded for the surgical approach, at least until postoperative day 5, but preferably until functional recovery has been attained. Secondary outcome measures are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life, and costs. DISCUSSION: The LEOPARD-2 trial is designed to assess whether MIPD reduces time to functional recovery, as compared with open pancreatoduodenectomy in an enhanced recovery setting.

trial registrationNetherlands Trial Register, NTR5689 . Registered on 2 March 2016.

Indexed as

LaparoscopyRobotic Surgical ProceduresClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicHumansMulticenter Studies as TopicNetherlandsPancreatic DiseasesPancreaticoduodenectomyPostoperative ComplicationsRandomized Controlled Trials as TopicRecovery of FunctionTime FactorsTreatment OutcomeLaparoscopicMinimally invasivePancreatoduodenectomyRobot-assistedWhipple

Identifiers

PMID29298706
PMCPMC5753506

What OpenQuestion holds

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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.