Evidence map›Paper›PMID 30080726›Full record

Trial reportAnnals of surgery2019

Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD): A Multicenter Patient-blinded Randomized Controlled Trial.

Thijs de Rooij, Jony van Hilst, Hjalmar van Santvoort, Djamila Boerma, Peter van den Boezem, Freek Daams, Ronald van Dam, Cees Dejong, Eino van Duyn, Marcel Dijkgraaf and 17 more

4 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in Annals of surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 267 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
267citing papers in PubMed, 17 pooled it
20.6field-weighted citation impact, top 1% 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.

NCT04855331 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer: An Multicenter Open-label Randomized Clinical Trial

TypeinterventionalSponsorFudan UniversityRan2021 to 2025Enrolled120ConditionsBorderline Resectable Pancreatic CancerArmsLaparoscopic pancreatoduodenectomy, Open pancreatoduodenectomy
NCT05939063 narecruitingnot on this mapstarted 2023, after this paper: background citation

Laparoscopic Radical Antegrade Modular Pancreatosplenectomy Versus Laparoscopic Distal Pancreatosplecnectomy in Selected Left-sided Pancreatic Cancer: a Multicenter Randomized Controlled Clinical Trial

TypeinterventionalSponsorFudan UniversityRan2023 to 2028Enrolled160ConditionsLeft-sided Pancreatic CancerArmsLRAMPS, LDP
NCT06167421 nanot yet recruitingnot on this mapstarted 2024, after this paper: background citation

Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy: A Multicenter Randomized Controlled Clinical Trial

TypeinterventionalSponsorFudan UniversityRan2024 to 2027Enrolled240ConditionsPancreatic Tumor, Benign, Pancreatic Neuroendocrine Tumor, Solid Pseudopapillary Tumor of the PancreasArmsLaparoscopic spleen-preserving distal pancreatectomy using the Kimura technique, Laparoscopic spleen-preserving distal pancreatectomy using the Warshaw technique
NCT06814249 naenrolling by invitationnot on this mapstarted 2024, after this paper: background citation

A Prospective Cohort Study on Ligation of Pancreatic Stump With Quantified Force During Distal Pancreatectomy

TypeinterventionalSponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRan2024 to 2025Enrolled60ConditionsDistal Pancreatectomy, Postoperative Pancreatic FistulaArmsligation of pancreatic stump with a quantified force, Manual suturing or stapling closure.
3 · Its place in the literature

Who cites it

267 citing papers in PubMed, 17 syntheses or guidelines pooled it, 587 citations in OpenAlex.

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  20. Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial

207 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 12 institutions in 3 countries.

Thijs de RooijDepartment of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.
Jony van HilstDepartment of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.
Hjalmar van SantvoortDepartment of Surgery, St Antonius Hospital, Nieuwegein, and University Medical Center Utrecht, Utrecht, the Netherlands.
Djamila BoermaDepartment of Surgery, St Antonius Hospital, Nieuwegein, and University Medical Center Utrecht, Utrecht, the Netherlands.
Peter van den BoezemDepartment of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.
Freek DaamsDepartment of Surgery, Cancer Center Amsterdam, VU University Medical Center, Amsterdam, the Netherlands.
Ronald van DamDepartment of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands, and Universitätsklinikum Aachen, Aachen, Germany.
Cees DejongDepartment of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands, and Universitätsklinikum Aachen, Aachen, Germany.
Eino van DuynDepartment of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands.
Marcel DijkgraafClinical Research Unit, Amsterdam UMC, University of Amsterdam, the Netherlands.
Casper van EijckDepartment of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.
Sebastiaan FestenDepartment of Surgery, OLVG, Amsterdam, the Netherlands.
Michael GerhardsDepartment of Surgery, OLVG, Amsterdam, the Netherlands.
Bas Groot KoerkampDepartment of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.
Ignace de HinghDepartment of Surgery, Catharina Hospital, Eindhoven, the Netherlands.
Geert KazemierDepartment of Surgery, Cancer Center Amsterdam, VU University Medical Center, Amsterdam, the Netherlands.
Joost KlaaseDepartment of Surgery, Medisch Spectrum Twente, Enschede, the Netherlands.
Ruben de KleineDepartment of Surgery, University Medical Center Groningen, Groningen, the Netherlands.
Cornelis van LaarhovenDepartment of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.
Misha LuyerDepartment of Surgery, Catharina Hospital, Eindhoven, the Netherlands.
Gijs PatijnDepartment of Surgery, Isala Clinics, Zwolle, the Netherlands.
Pascal SteenvoordeDepartment of Surgery, Isala Clinics, Zwolle, the Netherlands.
Mustafa SukerDepartment of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.
Moh'd Abu HilalDepartment of Surgery, Southampton University Hospital NHS Foundation Trust, Southampton, UK.
Olivier BuschDepartment of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.
Marc BesselinkDepartment of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.
Dutch Pancreatic Cancer Group
University of Amsterdam · NLAmsterdam UMC Location VUmc · NLRadboud University Nijmegen · NLSt. Antonius Ziekenhuis · NLUniversity Medical Center Utrecht · NLAmsterdam University Medical Centers · NLCatharina Ziekenhuis · NLMaastricht University · NLMedisch Spectrum Twente · NLRadboud University Medical Center · NLUniversitätsklinikum Aachen · DEUniversity Medical Center Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis trial followed a structured nationwide training program in minimally invasive distal pancreatectomy (MIDP), according to the IDEAL framework for surgical innovation, and aimed to compare time to functional recovery after minimally invasive and open distal pancreatectomy (ODP).

backgroundMIDP is increasingly used and may enhance postoperative recovery as compared with ODP, but randomized studies are lacking.

methodsA multicenter patient-blinded randomized controlled superiority trial was performed in 14 centers between April 2015 and March 2017. Adult patients with left-sided pancreatic tumors confined to the pancreas without vascular involvement were randomly assigned (1:1) to undergo MIDP or ODP. Patients were blinded for type of surgery using a large abdominal dressing. The primary endpoint was time to functional recovery. Analysis was by intention to treat. This trial was registered with the Netherlands Trial Register (NTR5689).

resultsTime to functional recovery was 4 days [interquartile range (IQR) 3-6) in 51 patients after MIDP versus 6 days (IQR 5-8) in 57 patients after ODP (P < 0.001). The conversion rate of MIDP was 8%. Operative blood loss was less after MIDP (150 vs 400 mL; P < 0.001), whereas operative time was longer (217 vs 179 minutes; P = 0.005). The Clavien-Dindo grade ≥III complication rate was 25% versus 38% (P = 0.21). Delayed gastric emptying grade B/C was seen less often after MIDP (6% vs 20%; P = 0.04). Postoperative pancreatic fistulas grade B/C were seen in 39% after MIDP versus 23% after ODP (P = 0.07), without difference in percutaneous catheter drainage (22% vs 20%; P = 0.77). Quality of life (day 3-30) was better after MIDP as compared with ODP, and overall costs were non-significantly less after MIDP. No 90-day mortality was seen after MIDP versus 2% (n = 1) after ODP.

conclusionsIn patients with left-sided pancreatic tumors confined to the pancreas, MIDP reduces time to functional recovery compared with ODP. Although the overall rate of complications was not reduced, MIDP was associated with less delayed gastric emptying and better quality of life without increasing costs.

Indexed as

Recovery of FunctionFemaleFollow-Up StudiesHumansLaparoscopyMaleMiddle AgedMinimally Invasive Surgical ProceduresPancreatectomyPancreatic NeoplasmsQuality of LifeRetrospective StudiesRobotic Surgical ProceduresTreatment Outcome

Identifiers

PMID30080726
OpenAlexW2887629794

What OpenQuestion holds

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Registered trials

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.