NCT05246657

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jun 2021Jul 2026

Study Start

First participant enrolled

June 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

5.1 years

First QC Date

February 4, 2022

Last Update Submit

March 10, 2025

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Outcome Measures

Primary Outcomes (1)

  • Clinical success

    Change major or equal than 2 mg/dl of total bilirrubine

    1 year

Study Arms (1)

intervention

EUS-guided Entero-biliary Anastomosis

Procedure: EUS-guided Entero-biliary Anastomosis

Interventions

EUS-guided Entero-biliary AnastomosisPROCEDURE

EUS-guided Entero-biliary Anastomosis

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Rio Hortega

Valladolid, 47012, Spain

RECRUITING

Study Officials

  • Carlos Maroto Martin, PI

    Hospital Rio Hortega

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Maroto Martín, PI

CONTACT

983420400cmarotom@saludcastillayleon.es

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2022

First Posted

February 18, 2022

Study Start

June 1, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)