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Recruiting NCT05246657

EUS-guided Entero-biliary Anastomosis for Therapeutic Access in Benign Biliary Obstructions

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Trial Parameters

Condition Cholangiopancreatography, Endoscopic Retrograde
Sponsor Hospital del Rio Hortega
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-06-01
Completion 2026-07-01
Interventions
EUS-guided Entero-biliary Anastomosis

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Brief Summary

Background: Transpapillary EUS-BD (rendezvous/antegrade) is gaining acceptance in BBO. The potential of transmural EUS-BD (hepaticogastrostomy/choledochoduodenostomy) in complex BBO warrants study. Aims: To assess feasibility and efficacy of TEA using transmural covered self-expandable metal-stents (cSEMS) to provide interval biliary drainage and create TAF for biliary endotherapy under cholangioscopy or fluoroscopy in BBO not amenable to ERCP.

Eligibility Criteria

Inclusion Criteria: * • Consecutive patients ≥ 18 years old. * Benign biliary obstruction. * ERCP failed or where ERCP could not be performed due to surgically-altered anatomy Exclusion Criteria: * • Refusal to sign the informed consent. * Malignant biliary obstruction * Coagulopathy (INR\>1.5) or trombocytopenia (\<50,000 platelets/mm3) uncorrectable. * Inability to tolerate the sedation necessary for the examination. * Pregnancy or lactation. * Unable to follow-up

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