Evidence map›Paper›PMID 36380155›Full record

ArticleCardiovascular and interventional radiology2023

A Multi-centre, Single Arm, Non-randomized, Prospective European Trial to Evaluate the Safety and Efficacy of the HistoSonics System in the Treatment of Primary and Metastatic Liver Cancers (#HOPE4LIVER).

Tze Min Wah, Maciej Pech, Maximilian Thormann, Xavier Serres, Peter Littler, Benjamin Stenberg, James Lenton, Jonathan Smith, Philipp Wiggermann, Mathis Planert and 3 more

Registry-linked trialOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article in Cardiovascular and interventional radiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04573881 (The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
5.7field-weighted citation impact, top 3% 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.

NCT04573881 naactive not recruitingnot on this map

The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER EU/UK)

TypeinterventionalSponsorHistoSonics, Inc.Ran2021 to 2027Enrolled24ConditionsLiver Neoplasms, Hepatocellular Carcinoma, Liver MetastasesArmsHistoSonics System
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 43 citations in OpenAlex.

  1. Integrating temperature-dependent tissue properties into focused ultrasound computational models for enhanced treatment planning.International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group · 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

13 authors at 8 institutions in 4 countries.

Tze Min WahDepartment of Diagnostic and Interventional Radiology, Institute of Oncology, St. James's University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK. tze.wah@nhs.net.ORCID http://orcid.org/0000-0001-5670-5454
Maciej PechDepartment of Interventional Radiology, Universitätsklinikum Magdeburg, Magdeburg, Germany.
Maximilian ThormannClinic for Radiology and Nuclear Medicine, University Hospital Magdeburg, Magdeburg, Germany.
Xavier SerresDepartment of Interventional Radiology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Peter LittlerDepartment of Interventional Radiology, Freeman Hospital, Newcastle Upon Tyne, UK.
Benjamin StenbergDepartment of Interventional Radiology, Freeman Hospital, Newcastle Upon Tyne, UK.
James LentonDepartment of Diagnostic and Interventional Radiology, Institute of Oncology, St. James's University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK.
Jonathan SmithDepartment of Diagnostic and Interventional Radiology, Institute of Oncology, St. James's University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK.
Philipp WiggermannDepartment of Interventional Radiology, Städtisches Klinikum Braunschweig, Brunswick, Germany.
Mathis PlanertDepartment of Interventional Radiology, Städtisches Klinikum Braunschweig, Brunswick, Germany.
Joan Vidal-JoveDepartment of Surgical Oncology, Institut Khuab for Interventional Oncology, Barcelona, Spain.
Guido TorzilliDepartment of Hepatobiliary & General Surgery, Humanitas University Hospital, Milan, Italy.
Luigi SolbiatiDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Freeman Hospital · GBHumanitas University · ITKlinikum Braunschweig · DELeeds Teaching Hospitals NHS Trust · GBKlinikum Magdeburg · DEUniversity Hospital Magdeburg · DEUniversity of Leeds · GBVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeImage-guided thermal ablation are established treatment options for non-surgical patients with primary and metastatic liver cancers. However, there are limitations with nonuniformity of cancer tissue destruction, heat sink effect and the risk of thermal ablative injury. The current non-thermal ablative techniques have high risk of local recurrence and are not widely adopted. Histotripsy is a treatment technology that destroys targeted tissue under ultrasound visualization via mechanical destruction through the precise application of acoustic cavitation and can offer the potential of non-invasive, non-thermal and non-ionizing radiation cancer treatment. The aim of this multi-centre non-randomized phase I/II trial is to assess the initial safety and efficacy of the prototype investigational 'System' in the treatment of primary and metastatic liver cancers. METHODS/

designAll non-surgical patients with primary/metastatic liver cancers having had previous liver directed therapy, radiation therapy or image-guided ablation may be offered image-guided Histotripsy as per trial protocol. The co-primary endpoints are technical success and procedural safety. Technical success is determined, at ≤ 36 h post procedure, by evaluating the histotripsy treatment size and coverage. The procedural safety is defined by procedure related major complications, defined as Common Terminology Criteria for Adverse Events (CTCAE version 5) grade 3 or higher toxicities, up to 30 days post procedure. This phase I/II trial has intended to recruit up to 45 patients to show safety and efficacy of image-guided histotripsy in liver cancers. TRAIL REGISTRATION: Clinicaltrials.gov identifier-NCT04573881; NIHR CRN CPMS-ID 47572.

Indexed as

High-Intensity Focused Ultrasound AblationLiver NeoplasmsHumansProspective StudiesUltrasonographyColorectal liver metastasesComplicationsHepatocellular carcinomaHistotripsyImage-guided ablationLiver cancerNon-thermal ablationTechnical successUltrasound

Identifiers

PMID36380155
PMCPMC9892119
OpenAlexW4309087689

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.