Evidence map›Paper›PMID 35233662›Full record

ArticleCardiovascular and interventional radiology2022

Study Protocol PROMETHEUS: Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma.

Timo T M Oosterveer, Gonnie C M van Erp, Pim Hendriks, Alexander Broersen, Christiaan G Overduin, Carla S P van Rijswijk, Arian R van Erkel, Rutger W van der Meer, Maarten E Tushuizen, Adriaan Moelker and 15 more

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

Article in Cardiovascular and interventional radiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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

8 citing papers in PubMed.

  1. [Clinical strategies and indication expansion of interventional ultrasonography ablative therapy for hepatic tumors].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026
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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

25 authors.

Timo T M Oosterveer *Department of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands. t.t.m.oosterveer@lumc.nl.
Gonnie C M van Erp *Department of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Pim HendriksDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Alexander BroersenDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Christiaan G OverduinDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.
Carla S P van RijswijkDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Arian R van ErkelDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Rutger W van der MeerDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Maarten E TushuizenDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
Adriaan MoelkerDepartment of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands.
Martijn R MeijerinkDepartment of Radiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Otto M van DeldenDepartment of Radiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Koert P de JongDepartment of Hepatobiliary and Pancreatic Surgery, University Medical Center Groningen, Groningen, The Netherlands.
Christiaan van der LeijDepartment of Radiology, Maastricht University Medical Center, Maastricht, The Netherlands.
Maarten L J SmitsDepartment of Radiology, University Medical Center Utrecht, Utrecht, The Netherlands.
Thijs A J UrlingsDepartment of Radiology, Haaglanden Medical Center, Hague, The Netherlands.
Jeffrey P B M BraakDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Elma Meershoek-Klein KranenbargDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Bianca van Duijn-de VreugdDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Evelijn ZeijdnerDutch Oncology Research Platform, Utrecht, The Netherlands.
Jelle J GoemanDepartment of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.
Jurgen J FüttererDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.
Minneke J CoenraadDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
Jouke DijkstraDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Mark C BurgmansDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.

Funding

KWF Kankerbestrijding 12879
6 · The paper itself

Abstract

purposeThe primary objective is to determine the minimal ablation margin required to achieve a local recurrence rate of < 10% in patients with hepatocellular carcinoma undergoing thermal ablation. Secondary objectives are to analyze the correlation between ablation margins and local recurrence and to assess efficacy. MATERIALS AND

methodsThis study is a prospective, multicenter, non-experimental, non-comparative, open-label study. Patients > 18 years with Barcelona Clinic Liver Cancer stage 0/A hepatocellular carcinoma (or B with a maximum of two lesions < 5 cm each) are eligible. Patients will undergo dual-phase contrast-enhanced computed tomography directly before and after ablation. Ablation margins will be quantitatively assessed using co-registration software, blinding assessors (i.e. two experienced radiologists) for outcome. Presence and location of recurrence are evaluated independently on follow-up scans by two other experienced radiologists, blinded for the quantitative margin analysis. A sample size of 189 tumors (~ 145 patients) is required to show with 80% power that the risk of local recurrence is confidently below 10%. A two-sided binomial z-test will be used to test the null hypothesis that the local recurrence rate is ≥ 10% for patients with a minimal ablation margin ≥ 2 mm. Logistic regression will be used to find the relationship between minimal ablation margins and local recurrence. Kaplan-Meier estimates are used to assess local and overall recurrence, disease-free and overall survival. DISCUSSION: It is expected that this study will result in a clear understanding of the correlation between ablation margins and local recurrence. Using co-registration software in future patients undergoing ablation for hepatocellular carcinoma may improve intraprocedural evaluation of technical success. Trial registration The Netherlands Trial Register (NL9713), https://www.trialregister.nl/trial/9713 .

Indexed as

Carcinoma, HepatocellularCatheter AblationLiver NeoplasmsHumansMargins of ExcisionMulticenter Studies as TopicNeoplasm Recurrence, LocalProspective StudiesTreatment OutcomeCo-registrationHepatocellular carcinomaLocal recurrenceMinimal ablation marginThermal ablation

Identifiers

PMID35233662
PMCPMC9018632

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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.