Evidence map›Paper›PMID 33386906›Full record

Trial reportAbdominal radiology (New York)2021

A pilot randomized controlled trial of endovascular coils and vascular plugs for proximal splenic artery embolization in high-grade splenic trauma.

Andrew J Gunn, Joel R Raborn, Russell Griffin, Shannon W Stephens, Joshua Richman, Jan O Jansen

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Abdominal radiology (New York), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 29% 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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
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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

6 authors at 2 institutions in 1 country.

Andrew J GunnDivision of Vascular and Interventional Radiology, Department of Radiology, University of Alabama at Birmingham, 619 19th St S, Birmingham, AL, 35249, USA. agunn@uabmc.edu.ORCID http://orcid.org/0000-0001-9081-446X
Joel R RabornDepartment of Radiology, University of Alabama at Birmingham, 619 19th St S, Birmingham, AL, 35249, USA.
Russell GriffinDepartment of Epidemiology, University of Alabama at Birmingham, 619 19th St S, Birmingham, AL, 35249, USA.
Shannon W StephensDivision of Acute Care Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.
Joshua RichmanDivision of Gastrointestinal Surgery, Department of Surgery, University of Alabama at Birmingham, 619 19th St S, Birmingham, AL, 35249, USA.
Jan O JansenDivision of Acute Care Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.
University of Alabama at Birmingham · USUniversity of Alabama at Birmingham Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the feasibility of enrolling patients in a randomized controlled trial (RCT) comparing endovascular coils (EC) and vascular plugs (VP) for proximal splenic artery embolization (pSAE) in high-grade splenic trauma, and to collect data to inform the design of a larger clinical effectiveness trial.

methodsSingle-center, prospective, RCT of patients with Grade III-V splenic injuries selected for nonoperative management. Patients were randomized to pSAE with EC or VP. The main outcome was feasibility. We also evaluated technical success, time to stasis, complications, mortality, and splenectomy rates, by estimating rates and 95% confidence intervals.

results46 of 50 eligible patients were enrolled (92%, 95% CI 90-100%). Overall, splenic salvage was 98% (45/46; 95% CI 94-100%). Primary technical success was observed in 22 EC patients (96%; 95% CI 87-100%) and 20 VP patients (87%; 95% CI 73-100%). Bayesian analysis suggests a > 80% probability that primary technical success is higher for EC. Two complications (one major and one minor) occurred in the EC group (9%; CI 0-20%) and one major complication occurred in the VP group (4%; CI 0-13%).

conclusionsRandomized comparisons of endovascular devices used for pSAE after trauma are feasible. pSAE using either EC or VP results in excellent rates of splenic salvage in trauma patients with high-grade splenic injuries. These high rates of splenic salvage and low rates of complications make their use as a primary outcome in a future trial problematic. Consideration should be given to technical parameters as a primary outcome for future trials.

Indexed as

Abdominal InjuriesEmbolization, TherapeuticHumansPilot ProjectsRetrospective StudiesSpleenSplenic ArteryTreatment OutcomeEmbolizationRandomized trialSpleenTrauma

Identifiers

PMID33386906
OpenAlexW3117842223

What OpenQuestion holds

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Registered trials

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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.