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
This trial does not accept healthy volunteersQualifiers
• 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 population
The study population includes patients with benign biliary obstruction in whom a temporary enterobiliary anastomosis is considered by transmural stent deployment. All consecutive patients who meet inclusion criteria and do not present exclusion criteria identified in the endoscopy units of the Río Hortega University Hospital in Valladolid will be invited to participate.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
EUS-guided Entero-biliary Anastomosis
Procedure/SurgeryEUS-guided Entero-biliary Anastomosis
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: intervention1 intervention
Trial outcomes
Primary outcomes
1
Clinical success
Change major or equal than 2 mg/dl of total bilirrubine
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov