Actively Recruiting

Age: 18Years +
All Genders
NCT05246657

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

Led by Hospital del Rio Hortega · Updated on 2025-03-11

50

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Consecutive patients 18 years or older
  • Diagnosed with benign biliary obstruction
  • ERCP failed or ERCP cannot be performed due to surgically altered anatomy
Not Eligible

You will not qualify if you...

  • Refusal to sign the informed consent
  • Malignant biliary obstruction
  • Uncorrectable coagulopathy (INR >1.5) or low platelets (<50,000/mm3)
  • Unable to tolerate sedation needed for the procedure
  • Pregnancy or lactation
  • Unable to follow-up during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Rio Hortega

Valladolid, Spain, 47012

Actively Recruiting

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Research Team

C

Carlos Maroto Martín, PI

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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