Evidence map›Paper›PMID 28166812›Full record

Trial reportTrials2017

Efficacy of high-intensity focused ultrasound-assisted hepatic resection (HIFU-AR) on blood loss reduction in patients with liver metastases requiring hepatectomy: study protocol for a randomized controlled trial.

Aurélien Dupré, David Pérol, Ellen Blanc, Patrice Peyrat, Valéria Basso, Yao Chen, Jérémy Vincenot, Anthony Kocot, David Melodelima, Michel Rivoire

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
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. It is linked to trial NCT02728167 (Randomized, Open-label, Phase II Study to Evaluate the Efficacy of High-Intensity Focused Ultrasound Assisted Hepatic Resection), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 31% 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.

NCT02728167 naterminatednot on this map

Randomized, Open-label, Phase II Study to Evaluate the Efficacy of High-Intensity Focused Ultrasound Assisted Hepatic Resection (HIFU-AR) on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy

TypeinterventionalSponsorCentre Leon BerardRan2016 to 2018Enrolled50ConditionsLiver MetastasisArmsPre-coagulation of the liver parenchyma with HIFU
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Review of Robot-Assisted HIFU Therapy.Sensors (Basel, Switzerland) · 2023
    Review
  3. Article
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

10 authors at 2 institutions in 2 countries.

Aurélien DupréDepartment of Surgical Oncology, Centre Léon Bérard, 28 Rue Laennec, Lyon, 69008, France. aurelien.dupre@lyon.unicancer.fr.ORCID 0000-0002-5216-538X
David PérolDepartment of Clinical Research (DRCI), Centre Léon Bérard, Lyon, 69008, France.
Ellen BlancDepartment of Clinical Research (DRCI), Centre Léon Bérard, Lyon, 69008, France.
Patrice PeyratDepartment of Surgical Oncology, Centre Léon Bérard, 28 Rue Laennec, Lyon, 69008, France.
Valéria BassoDepartment of Surgical Oncology, Centre Léon Bérard, 28 Rue Laennec, Lyon, 69008, France.
Yao ChenDepartment of Surgical Oncology, Centre Léon Bérard, 28 Rue Laennec, Lyon, 69008, France.
Jérémy VincenotInserm, U1032, LabTau, University of Lyon, Lyon, 69003, France.
Anthony KocotInserm, U1032, LabTau, University of Lyon, Lyon, 69003, France.
David MelodelimaInserm, U1032, LabTau, University of Lyon, Lyon, 69003, France.
Michel RivoireDepartment of Surgical Oncology, Centre Léon Bérard, 28 Rue Laennec, Lyon, 69008, France.
Centre Léon Bérard · FRUniversité Claude Bernard Lyon 1 · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLiver resection is the only potentially curative treatment for colorectal liver metastases (LM). It is considered a safe procedure, but is often associated with blood loss during liver transection. Blood transfusions are frequently needed, but they are associated with increased morbidity and risk of recurrence. Many surgical devices have been developed to decrease blood loss. However, none of them has proven superior to the standard crushing technique. We developed a new, powerful intra-operative high-intensity focused ultrasound (HIFU) transducer which destroys tissue by coagulative necrosis. We aim to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss.

methodsThis is a prospective, single-centre, randomized (1:1 ratio), comparative, open-label phase II study. Patients with LM requiring a hepatectomy for ≥ 2 segments will be included. Patients with cirrhosis or sinusoidal obstruction syndrome with portal hypertension will be excluded. The primary endpoint is normalized blood loss in millilitres per square centimetre of liver section plane. Secondary endpoints are: total blood loss, transection time, transection time per square centimetre of liver area, haemostasis time, clip density on the liver section area, rate and duration of the Pringle manœuvre, rate of patients needing a blood transfusion, length of hospital stay, morbidity, patients with positive resection margin, and local recurrence. Assuming a blood loss of 7.6 ± 3.7 mL/cm DISCUSSION: We previously demonstrated the safety and efficacy of intra-operative HIFU in patients operated on for LM. We also demonstrated the efficacy of HIFU-AR in a preclinical study. Participants in the HIFU-AR group of this randomized trial can expect to benefit from reduced blood loss and decreased ischemia of liver parenchyma.

trial registrationClinicaltrial.gov, NCT02728167 . Registered on 22 March 2016.

Indexed as

High-Intensity Focused Ultrasound AblationBlood Loss, SurgicalClinical ProtocolsColorectal NeoplasmsEquipment DesignFranceHepatectomyHumansLength of StayLiver NeoplasmsOperative TimePostoperative ComplicationsProspective StudiesResearch DesignTime FactorsTransducersBlood lossBlood transfusionHepatectomyHIFUHigh-intensity focused ultrasoundLiver metastasisLiver surgeryLiver transectionRandomized trial

Identifiers

PMID28166812
PMCPMC5294714
OpenAlexW2587616444

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.