RecruitingNCT05246657

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

EUS-guided Entero-biliary Anastomosis as Fistulas for Therapeutic Access in Benign Biliary Obstructions Not Accessible by ERCP


Sponsor

Hospital del Rio Hortega

Enrollment

50 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • • Consecutive patients ≥ 18 years old.
  • Benign biliary obstruction.
  • ERCP failed or where ERCP could not be performed due to surgically-altered anatomy

Exclusion Criteria6

  • • 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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Interventions

PROCEDUREEUS-guided Entero-biliary Anastomosis

EUS-guided Entero-biliary Anastomosis


Locations(1)

Hospital Rio Hortega

Valladolid, Spain

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NCT05246657


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