Evidence map›Paper›PMID 29439711›Full record

ArticleTrials2018

Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial.

Kurinchi Gurusamy, Neil Corrigan, Julie Croft, Maureen Twiddy, Stephen Morris, Nick Woodward, Steve Bandula, Daniel Hochhauser, Vicky Napp, Alison Pullan and 7 more

Open access · goldAbstract readClinical Trial Protocol
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 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
4.4field-weighted citation impact, top 4% 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.

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

25 citing papers in PubMed, 54 citations in OpenAlex.

  1. Trial
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  15. Review
  16. Liver metastases.Nature reviews. Disease primers · 2021
    Review
  17. Article
  18. Review
  19. Review
  20. Thermal Ablation versus SBRT in liver tumours: pros and cons.Medical oncology (Northwood, London, England) · 2020
    Review
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

17 authors at 8 institutions in 2 countries.

Kurinchi GurusamyRoyal Free Campus, Division of Surgery and Interventional Science, University College London, 9th Floor, Royal Free Hospital, Rowland Hill Street, NW3 2PF, London, UK.ORCID http://orcid.org/0000-0002-0313-9134
Neil CorriganClinical Trials Research Unit, Leeds Institute of Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Julie CroftClinical Trials Research Unit, Leeds Institute of Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Maureen TwiddyInstitute of Clinical and Applied Health Research, University of Hull, Hull, UK.
Stephen MorrisDepartment of Applied Health Research, University College London, London, UK.
Nick WoodwardDepartment of Radiology, Royal Free Hospital, London, UK.
Steve BandulaDepartment of Radiology, University College London Hospital, London, UK.
Daniel HochhauserCancer Institute, University College London, London, UK.
Vicky NappClinical Trials Research Unit, Leeds Institute of Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Alison PullanClinical Trials Research Unit, Leeds Institute of Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Nicholas JakowiwRoyal Free Campus, Division of Surgery and Interventional Science, University College London, 9th Floor, Royal Free Hospital, Rowland Hill Street, NW3 2PF, London, UK.
Raj PrasadDepartment of Surgery and Transplantation, Leeds Teaching Hospital, Leeds, UK.
Steven Olde DaminkDepartment of General Surgery, Maastricht University, Maastricht, The Netherlands.
C J H M van LaarhovenDepartment of Surgery, Radboud University Medical Center, Radboud, The Netherlands.
Johannes H W de WiltDepartment of Surgery, Radboud University Medical Center, Radboud, The Netherlands.
Julia BrownClinical Trials Research Unit, Leeds Institute of Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Brian R DavidsonRoyal Free Campus, Division of Surgery and Interventional Science, University College London, 9th Floor, Royal Free Hospital, Rowland Hill Street, NW3 2PF, London, UK. k.gurusamy@ucl.ac.uk.
University of Leeds · GBThe Royal Free Hospital · GBRadboud University Nijmegen · NLUniversity College London · GBLeeds Teaching Hospitals NHS Trust · GBMaastricht University · NLUniversity College Hospital · GBUniversity of Hull · GB

Funding

Department of Health HTA/13/153/04Health Technology Assessment Programme 13/153/04
6 · The paper itself

Abstract

backgroundAlthough surgical resection has been considered the only curative option for colorectal liver metastases (CLM), thermal ablation has recently been suggested as an alternative curative treatment. A prospective randomised trial is required to define the efficacy of resection vs ablation for the treatment of colorectal liver metastases.

methodsDesign and setting: This is a multicentre, open, randomised controlled non-inferiority trial design with internal pilot and will be performed in tertiary liver centres in UK and The Netherlands.

participantsEligible patients will be those with colorectal liver metastases at high surgical risk because of their age, co-morbidities or tumour burden and who would be suitable for liver resection or thermal ablation.

interventionThermal ablation as per local policy. CONTROL: Surgical liver resection performed as per centre protocol. Co-interventions: Further chemotherapy will be offered to patients as per current practice. Outcomes Pilot study: Same as main study and in addition patients and clinicians' acceptability of the trial to assist in optimisation of recruitment. PRIMARY OUTCOME: Disease-free survival (DFS) at two years post randomisation. SECONDARY OUTCOMES: Overall survival, timing and site of recurrence, additional therapy after treatment failure, quality of life, complications, length of hospital stay, costs, trial acceptability, DFS measured from end of intervention. FOLLOW-UP: 24 months from randomisation; five-year follow-up for overall survival. SAMPLE SIZE: 330 patients to demonstrate non-inferiority of thermal ablation. DISCUSSION: This trial will determine the effectiveness and cost-effectiveness of thermal ablation vs surgical resection for high-risk people with colorectal liver metastases, and guide the optimal treatment for these patients.

trial registrationISRCTN Registry, ISRCTN52040363 . Registered on 9 March 2016.

Indexed as

HepatectomyRadiofrequency AblationChemotherapy, AdjuvantColorectal NeoplasmsDisease-Free SurvivalEquivalence Trials as TopicHumansLiver NeoplasmsMicrowavesMulticenter Studies as TopicNetherlandsPilot ProjectsPostoperative ComplicationsPragmatic Clinical Trials as TopicProspective StudiesTime FactorsAblation techniquesColorectal neoplasmsCost-benefit analysisHepatectomyLiverNeoplasm metastasisRandomised controlled trial

Identifiers

PMID29439711
PMCPMC5811975
OpenAlexW2788049756

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.