EUS-guided Entero-biliary Anastomosis for Therapeutic Access in Benign Biliary Obstructions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital del Rio Hortega
About this trial
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
Qualifiers
• Consecutive patients ≥ 18 years old.
Benign biliary obstruction.
ERCP failed or where ERCP could not be performed due to surgically-altered anatomy
Disqualifiers
• 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.
Trial design
Treatments tested in this trial
- EUS-guided Entero-biliary Anastomosis
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov