Evidence map›Paper›PMID 25393877›Full record

Trial reportPloS one2014

Prospective randomized trial of enoxaparin, pentoxifylline and ursodeoxycholic acid for prevention of radiation-induced liver toxicity.

Max Seidensticker, Ricarda Seidensticker, Robert Damm, Konrad Mohnike, Maciej Pech, Bruno Sangro, Peter Hass, Peter Wust, Siegfried Kropf, Günther Gademann and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01149304 (Evaluation of the Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity After Brachytherapy of Liver Metastases From Colorectal Carcinoma, Assessed in a Prospective Randomised Trial), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
2.6field-weighted citation impact, top 9% 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.

NCT01149304 phase2completednot on this map

Evaluation of the Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity After Brachytherapy of Liver Metastases From Colorectal Carcinoma, Assessed in a Prospective Randomised Trial

TypeinterventionalSponsorUniversity of MagdeburgRan2009Enrolled22ConditionsColorectal Cancer, Liver Metastases, Irradiation Damage, Radiation Induced Liver DiseaseArmsPentoxifylline, Ursodeoxycholic Acid, Enoxaparin
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 65 citations in OpenAlex.

  1. Trial
  2. Radioablation of liver malignancies with interstitial high-dose-rate brachytherapy : Complications and risk factors.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2016
    Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. The Impact of UnilateralAnnals of surgery open : perspectives of surgical history, education, and clinical approaches · 2021
    Article
  9. Article
  10. Article
  11. Redox-Dependent Effects in the Physiopathological Role of Bile Acids.Oxidative medicine and cellular longevity · 2021
    Review
  12. Article
  13. Radiation-Induced Liver Disease and Modern Radiotherapy.Seminars in radiation oncology · 2018
    Review
  14. Direct dose correlation of MRI morphologic alterations of healthy liver tissue after robotic liver SBRT.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2018
    Article
  15. Article
  16. Radioembolization of Colorectal Liver Metastases: Indications, Technique, and Outcomes.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2017
    Review
  17. MRI morphologic alterations after liver SBRT : Direct dose correlation with intermodal matching.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2016
    Article
  18. Review
  19. Article
  20. 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

11 authors at 4 institutions in 3 countries.

Max SeidenstickerUniversitätsklinik Magdeburg, Klinik für Radiologie und Nuklearmedizin, Magdeburg, Germany; International School of Image-Guided Interventions, Deutsche Akademie für Mikrotherapie, Magdeburg, Germany.
Ricarda SeidenstickerUniversitätsklinik Magdeburg, Klinik für Radiologie und Nuklearmedizin, Magdeburg, Germany; International School of Image-Guided Interventions, Deutsche Akademie für Mikrotherapie, Magdeburg, Germany.
Robert DammUniversitätsklinik Magdeburg, Klinik für Radiologie und Nuklearmedizin, Magdeburg, Germany; International School of Image-Guided Interventions, Deutsche Akademie für Mikrotherapie, Magdeburg, Germany.
Konrad MohnikeUniversitätsklinik Magdeburg, Klinik für Radiologie und Nuklearmedizin, Magdeburg, Germany; International School of Image-Guided Interventions, Deutsche Akademie für Mikrotherapie, Magdeburg, Germany.
Maciej PechUniversitätsklinik Magdeburg, Klinik für Radiologie und Nuklearmedizin, Magdeburg, Germany; International School of Image-Guided Interventions, Deutsche Akademie für Mikrotherapie, Magdeburg, Germany; Medical University of Gdansk, 2nd Department of Radiology, Gdansk, Poland.
Bruno SangroClinica Universidad de Navarra, Liver Unit, Department of Internal Medicine, Pamplona, Spain.
Peter HassUniversitätsklinik Magdeburg, Klinik für Strahlentherapie, Magdeburg, Germany.
Peter WustCharité Universitätsmedizin Berlin, Klinik für Radioonkologie und Strahlentherapie, Berlin, Germany.
Siegfried KropfUniversitätsklinik Magdeburg, Institut für Biometrie und Medizinische Informatik, Magdeburg, Germany.
Günther GademannUniversitätsklinik Magdeburg, Klinik für Strahlentherapie, Magdeburg, Germany.
Jens RickeUniversitätsklinik Magdeburg, Klinik für Radiologie und Nuklearmedizin, Magdeburg, Germany; International School of Image-Guided Interventions, Deutsche Akademie für Mikrotherapie, Magdeburg, Germany.
Klinikum Magdeburg · DEUniversitätsklinik für Strahlentherapie · DECharité - Universitätsmedizin Berlin · DEClinica Universidad de Navarra · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimTargeted radiotherapy of liver malignancies has found to be effective in selected patients. A key limiting factor of these therapies is the relatively low tolerance of the liver parenchyma to radiation. We sought to assess the preventive effects of a combined regimen of pentoxifylline (PTX), ursodeoxycholic acid (UDCA) and low-dose low molecular weight heparin (LMWH) on focal radiation-induced liver injury (fRILI). METHODS AND MATERIALS: Patients with liver metastases from colorectal carcinoma who were scheduled for local ablation by radiotherapy (image-guided high-dose-rate interstitial brachytherapy) were prospectively randomized to receive PTX, UDCA and LMWH for 8 weeks (treatment) or no medication (control). Focal RILI at follow-up was assessed using functional hepatobiliary magnetic resonance imaging (MRI). A minimal threshold dose, i.e. the dose to which the outer rim of the fRILI was formerly exposed to, was quantified by merging MRI and dosimetry data.

resultsResults from an intended interim-analysis made a premature termination necessary. Twenty-two patients were included in the per-protocol analysis. Minimal mean hepatic threshold dose 6 weeks after radiotherapy (primary endpoint) was significantly higher in the study treatment-group compared with the control (19.1 Gy versus 14.6 Gy, p = 0.011). Qualitative evidence of fRILI by MRI at 6 weeks was observed in 45.5% of patients in the treatment versus 90.9% of the control group. No significant differences between the groups were observed at the 12-week follow-up.

conclusionsThe post-therapeutic application of PTX, UDCA and low-dose LMWH significantly reduced the extent and incidence fRILI at 6 weeks after radiotherapy. The development of subsequent fRILI at 12 weeks (4 weeks after cessation of PTX, UDCA and LMWH during weeks 1-8) in the treatment group was comparable to the control group thus supporting the observation that the agents mitigated fRILI.

trial registrationEU clinical trials register 2008-002985-70 ClinicalTrials.gov NCT01149304.

Indexed as

Liver NeoplasmsAgedAged, 80 and overBrachytherapyColorectal NeoplasmsEnoxaparinFemaleHumansMaleMiddle AgedNeoplasm MetastasisPentoxifyllineProspective StudiesRadiation InjuriesUrsodeoxycholic AcidEnoxaparinPentoxifyllineUrsodeoxycholic Acid

Identifiers

PMID25393877
PMCPMC4231047
OpenAlexW2087623033

What OpenQuestion holds

Textmetadata
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.