Clinical Trial

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

Study acronym: ATENHEA
Recruiting
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Record status
This record was last updated March 11, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-02-15; most recent amendment 2025-03-10.
Trial Details
NCT Number NCT05246657
Lead Sponsor Hospital del Rio Hortega
Conditions Cholangiopancreatography, Endoscopic Retrograde
Enrollment 50 participants
Start Date 2021-06-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-11