Evidence map›Paper›PMID 40129530›Full record

ArticleDEN open2025

Pilot study of a novel lumen-apposing metal stent for endoscopic ultrasound-guided procedures in porcine models.

Benedetto Mangiavillano, Gianluca Franchellucci, Francesco Auriemma, Daryl Ramai, Alberto Larghi, Danilo Paduano, Diletta De Deo, Federica Calabrese, Carmine Gentile, Matteo Fiacca and 2 more

Abstract read
In one paragraph

Article in DEN open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

12 authors.

Benedetto MangiavillanoGastrointestinal Endoscopy Unit Humanitas - Mater Domini Castellanza Italy.
Gianluca FranchellucciDepartment of Biomedical Sciences Humanitas University Milan Italy.ORCID https://orcid.org/0000-0002-3440-4981
Francesco AuriemmaGastrointestinal Endoscopy Unit Humanitas - Mater Domini Castellanza Italy.
Daryl RamaiDivision of Gastroenterology and Hepatology The University of Utah School of Medicine Salt Lake City Utah USA.
Alberto LarghiDigestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Rome Italy.
Danilo PaduanoGastrointestinal Endoscopy Unit Humanitas - Mater Domini Castellanza Italy.
Diletta De DeoDepartment of Biomedical Sciences Humanitas University Milan Italy.
Federica CalabreseGastrointestinal Endoscopy Unit Humanitas - Mater Domini Castellanza Italy.
Carmine GentileGastrointestinal Endoscopy Unit Humanitas - Mater Domini Castellanza Italy.
Matteo FiaccaGastrointestinal Endoscopy Unit Humanitas - Mater Domini Castellanza Italy.
Antonio FacciorussoDepartment of Medical Sciences, Gastroenterology Unit University of Foggia Foggia Italy.
Alessandro RepiciDepartment of Biomedical Sciences Humanitas University Milan Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Lumen-apposing metal stents have expanded the therapeutic potential of interventional endoscopic ultrasound (EUS). The Hot-Spaxus (Taewoong Medical Co., Ltd.), the second most commonly utilized lumen-apposing metal stent, requires two operators for its release which has been considered a limitation compared to other lumen-apposing metal stents. We aimed to test the feasibility and the technical success of a newly available version of the Hot-Spaxus stent equipped with an innovative handle delivery system for EUS-guided interventional procedures. We conducted a pilot study using porcine models. The novel Hot-Spaxus 2 was tested by performing four EUS-guided procedures including four EUS-guided gallbladder drainage and 12 EUS-guided gastrojejunostomy) procedures. Technical success was reported in 100% of cases. The mean procedure time for EUS-guided gatrojejunostomyJ and EUS-guided gallbladder drainage was 23.85 min (standard deviation 3.41) and 16.15 min (standard deviation 2.72), respectively. The distal and proximal flanges were safely released by the endosonographer without any complications. No adverse events were reported. In conclusion, the novel Hot-Spaxus 2 stent may represent an improvement compared to the prior Spaxus model. Unlike its predecessor, this newly designed stent eliminates the need for two endoscopists and can be deployed by a single operator. Further human studies are necessary to validate its clinical effectiveness.

Indexed as

endoscopic ultrasoundEUS‐GBDEUS‐GEHot‐Spaxuslumen‐apposing metal stents

Identifiers

PMID40129530
PMCPMC11930856

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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.