Evidence map›Paper›PMID 22722717›Full record

Trial reportCardiovascular and interventional radiology2013

Phase II study of chemoembolization with drug-eluting beads in patients with hepatic neuroendocrine metastases: high incidence of biliary injury.

Nikhil Bhagat, Diane K Reyes, Mingde Lin, Ihab Kamel, Timothy M Pawlik, Constantine Frangakis, J F Geschwind

Abstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cardiovascular and interventional radiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 pooled it
4.5field-weighted citation impact, top 5% 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

47 citing papers in PubMed, 2 syntheses or guidelines pooled it, 100 citations in OpenAlex.

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  20. [Treatment and prevention of bile duct injury in hepatocellular carcinoma after transarterial chemoembolization].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2021
    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

7 authors at 4 institutions in 2 countries.

Nikhil BhagatDivision of Vascular and Interventional Radiology, Department of Radiology, Johns Hopkins University Medical Center, The Johns Hopkins Hospital, Sheikh Zayed Tower, Suite 7203, Baltimore, MD 21287, USA. nbhagat1@jhmi.edu
Diane K Reyes
Mingde Lin
Ihab Kamel
Timothy M Pawlik
Constantine Frangakis
J F Geschwind
Johns Hopkins Hospital · USJohns Hopkins University · USUniversity Medical Center · USPhilips (United States) · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
See, Reach, Treat Tumor-Optimized Transarterial Chemoembolization DrugDeliveryR01CA160771 · NCI · YALE UNIVERSITY · PI GESCHWIND, JEAN-FRANCOIS H, LIN, MINGDE · 2011 to 2015
$2.6M
NCI NIH HHS P30 CA006973NCI NIH HHS R01 CA160771NCI NIH HHS R01CA160771-2
6 · The paper itself

Abstract

purposeTo evaluate safety in an interim analysis of transarterial chemoembolization (TACE) with doxorubicin-eluting beads (DEB) in 13 patients with hepatic metastases from neuroendocrine tumors (NETs) as part of a phase II trial.

methodsInstitutional Review Board approval and informed consent were obtained. Thirteen patients completed preliminary safety analysis. Their mean age was 65 years, Eastern Cooperative Oncology Group status was 0/1, tumor burden range was 4-75 %, and mean targeted tumor size was 5.9 cm. Up to four DEB-TACE sessions (100-300 μm beads loaded with ≤100 mg doxorubicin) within 6 months were allowed. Tumor response was assessed by magnetic resonance imaging 1 month after treatment using contrast-enhancement [European Association for the Study of the Liver (EASL) and size Response Evaluation Criteria in Solid Tumors (RECIST)] criteria. Safety was assessed by National Cancer Institute Common Terminology Criteria.

resultsDEB-TACE was successfully performed in all 13 patients. At 1 month follow-up, there was a mean 12 % decrease in tumor size (p < 0.0003) and a 56 % decrease in tumor enhancement (p < 0.0001). By EASL criteria, the targeted lesion objective response rate was 78 %. Grade 3 to 4 toxicities were fatigue (23 %), increased alanine amino transferase (15 %), hyperglycemia (15 %), and abdominal pain (8 %). Seven patients developed bilomas (54 %); all of these patients had multiple small (<4 cm) lesions. Subsequently, four underwent percutaneous drainage, three for abscess formation and one for symptoms related to mass effect.

conclusionsAlthough biloma and liver abscess are known risks after TACE, the high incidence in our study population was unexpected and forced interruption of the trial. Although this occurred in a small group of patients, we have changed our technique and patient selection as a result of these findings, thus allowing resumption of the trial.

Indexed as

AgedAntibiotics, AntineoplasticBiliary TractChemoembolization, TherapeuticContrast MediaDoxorubicinFemaleHumansIncidenceLiver NeoplasmsMagnetic Resonance ImagingMaleMicrospheresNeuroendocrine TumorsPatient SelectionTreatment OutcomeAntibiotics, AntineoplasticContrast MediaDoxorubicin

Identifiers

PMID22722717
PMCPMC3596485
OpenAlexW2000600513

What OpenQuestion holds

Textmetadata
LicenceTDM
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.