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Initial clinical experience of a steerable access device for EUS-guided biliary drainage - 24/12/19

Doi : 10.1016/j.gie.2019.07.035 
Marvin Ryou, MD 1, Petros C. Benias, MD 2, Vivek Kumbhari, MD 3,
1 Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA 
2 Division of Gastroenterology, Northwell Health, North Shore University Hospital, Manhasset, New York, USA 
3 Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA 

Reprint requests: Vivek Kumbhari, MD, Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Sheikh Zayed Building, 1800 Orleans St, Suite 7125G, Baltimore, MD 21287.Division of Gastroenterology and HepatologyJohns Hopkins Medical InstitutionsSheikh Zayed Building1800 Orleans StSuite 7125GBaltimoreMD21287

Abstract

Background and Aims

EUS-guided biliary drainage (EUS-BD) has been used as a rescue procedure after failed endoscopic retrograde cholangiography (ERC), and there is growing interest in EUS-BD as a primary therapy for distal malignant biliary obstruction. After EUS-guided needle puncture of an obstructed bile duct, directional control of wire advancement remains an area of need, potentially addressed by a new steerable EUS access system. The aim of this study was to evaluate the safety and efficacy of this novel steerable access system in patients undergoing EUS-BD after failed ERC.

Methods

We performed a retrospective study of prospectively acquired data at 3 tertiary academic hospitals. Consecutive patients who had failed ERC followed by EUS-BD using the access device were included. Primary outcomes were safety and technical feasibility (successful completion of EUS-BD). Secondary outcomes were clinical success (75% improvement in liver function tests at 30 days) and device performance.

Results

Twenty-two consecutive patients underwent EUS-BD between October 10, 2018 and March 3, 2019. Needle puncture and selective wire advancement in the intended direction were both successful in 100% of cases (22/22). Technical success was 95% (21/22). Fifty-nine percent (13) underwent rendezvous, 32% (7) underwent choledochoduodenostomy, and 4.5% (1) underwent hepaticogastrostomy. One patient (4.5%) underwent percutaneous transhepatic cholangiography. There were no cases of wire shearing. The adverse event rate was 4.5% (mild pancreatitis in 1 patient). There was no bile leak, bleeding, or death at 30 days' follow-up.

Conclusions

This first clinical experience with a steerable access system for EUS-BD suggests it is safe and effective, particularly with regard to controlling direction of wire advancement.

Il testo completo di questo articolo è disponibile in PDF.

Abbreviations : CDS, ERC, EUS-BD, FDA, HGS, PTBD, RDV


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 DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: M. Ryou: Consultant for Covidien/Medtronic, GI Windows, Pentax, Fuji, Olympus, and EnteraSense; research support from Olympus. P. C. Benias: Consultant for Covidien/Medtronic. V. Kumbhari: Consultant for Covidien/Medtronic, Pentax Medical, Boston Scientific, Apollo Endosurgery, and Obalon; research support from Apollo Endosurgery and Erbe USA.
 If you would like to chat with an author of this article, you may contact Dr Kumbhari at vkumbhari@gmail.com.


© 2020  American Society for Gastrointestinal Endoscopy. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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