Evidence map›Paper›PMID 26497813›Full record

Trial reportBMC cancer2015

Colorectal liver metastatic disease: efficacy of irreversible electroporation--a single-arm phase II clinical trial (COLDFIRE-2 trial).

Hester J Scheffer, Laurien G P H Vroomen, Karin Nielsen, Aukje A J M van Tilborg, Emile F I Comans, Cornelis van Kuijk, Bram B van der Meijs, Janneke van den Bergh, Petrousjka M P van den Tol, Martijn R Meijerink

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02082782 (Colorectal Metastatic Liver Disease), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
5.9field-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.

NCT02082782 phase2completednot on this map

Colorectal Metastatic Liver Disease: Efficacy of Irreversible Electroporation (IRE) - a Phase II Clinical Trial (COLDFIRE-2 Study)

TypeinterventionalSponsorAmsterdam UMC, location VUmcRan2014 to 2020Enrolled51ConditionsColorectal Liver MetastasesArmsIrreversible electroporation (IRE)
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Irreversible Electroporation Enhances Solid Tumor Infiltration and Selective Cancer Cell Lysis by CAR T Cells.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. Tissue Ablation: Applications and Perspectives.Advanced materials (Deerfield Beach, Fla.) · 2024
    Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Modern therapeutic approaches for the treatment of malignant liver tumours.Nature reviews. Gastroenterology & hepatology · 2020
    Review
  14. Article
  15. Article
  16. Hepatic metastasis from colorectal cancer.Journal of gastrointestinal oncology · 2019
    Review
  17. Normal and fibrotic liver parenchyma respond differently to irreversible electroporation.HPB : the official journal of the International Hepato Pancreato Biliary Association · 2019
    Article
  18. Article
  19. Article
  20. 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 1 institution in 1 country.

Hester J SchefferDepartment of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. hj.scheffer@vumc.nl.
Laurien G P H VroomenDepartment of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. la.vroomen@vumc.nl.
Karin NielsenDepartment of Surgery, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. k.nielsen@vumc.nl.
Aukje A J M van TilborgDepartment of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. a.vantilborg@vumc.nl.
Emile F I ComansDepartment of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. efi.comans@vumc.nl.
Cornelis van KuijkDepartment of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. c.vankuijk@vumc.nl.
Bram B van der MeijsDepartment of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. b.vandermeijs@vumc.nl.
Janneke van den BerghDepartment of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. j.vandenbergh@vumc.nl.
Petrousjka M P van den TolDepartment of Surgery, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. mp.vandentol@vumc.nl.
Martijn R MeijerinkDepartment of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. mr.meijerink@vumc.nl.
Amsterdam UMC Location Vrije Universiteit Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIrreversible electroporation (IRE) is a novel image-guided tumor ablation technique that has shown promise for the ablation of lesions in proximity to vital structures such as blood vessels and bile ducts. The primary aim of the COLDFIRE-2 trial is to investigate the efficacy of IRE for unresectable, centrally located colorectal liver metastases (CRLM). Secondary outcomes are safety, technical success, and the accuracy of contrast-enhanced (ce)CT and (18)F-FDG PET-CT in the detection of local tumor progression (LTP). METHODS/

designIn this single-arm, multicenter phase II clinical trial, twenty-nine patients with (18)F-FDG PET-avid CRLM ≤ 3,5 cm will be prospectively included to undergo IRE of the respective lesion. All lesions must be unresectable and unsuitable for thermal ablation due to vicinity of vital structures. Technical success is based on ceMRI one day post-IRE. All complications related to the IRE procedure are registered. Follow-up consists of (18)F-FDG PET-CT and 4-phase liver CT at 3-monthly intervals during the first year of follow-up. Treatment efficacy is defined as the percentage of tumors successfully eradicated 12 months after the initial IRE procedure based on clinical follow-up using both imaging modalities, tumor marker and (if available) histopathology. To determine the accuracy of (18)F-FDG PET-CT and ceCT, both imaging modalities will be individually scored by two reviewers that are blinded for the final oncologic outcome. DISCUSSION: To date, patients with a central CRLM unsuitable for resection or thermal ablation have no curative treatment option and are given palliative chemotherapy. For these patients, IRE may prove a life-saving treatment option. The results of the proposed trial may represent an important step towards the implementation of IRE for central liver tumors in the clinical setting.

trial registrationTRIAL REGISTRATION NUMBER: NCT02082782.

Indexed as

ElectroporationAblation TechniquesAgedColorectal NeoplasmsFemaleFluorodeoxyglucose F18HumansLiver NeoplasmsMaleMiddle AgedSurvival AnalysisTomography, X-Ray ComputedFluorodeoxyglucose F18

Identifiers

PMID26497813
PMCPMC4619419
OpenAlexW1928832099

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.