EUS-guided procedure for treating benign biliary obstructions
Official title: EUS-guided Entero-biliary Anastomosis as Fistulas for Therapeutic Access in Benign Biliary Obstructions Not Accessible by ERCP
Run by Hospital del Rio Hortega · NCT05246657 · Data updated 2026-11-12
This study is testing a new way to treat benign bile duct blockages using a special stent for patients who haven't had success with other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Hospital del Rio Hortega Academic / other |
| Locations | 1 site (Valladolid) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | July 1, 2026 |
| Study ends | July 1, 2026 |
| Registry record updated | March 11, 2025 |
| Trial ID | NCT05246657 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with benign biliary obstruction who have experienced failure of ERCP or have surgically-altered anatomy.
✕Probably not a fit
Patients with malignant biliary obstructions, coagulopathy, or those unable to tolerate sedation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the feasibility and effectiveness of EUS-guided entero-biliary anastomosis using covered self-expandable metal stents for patients with benign biliary obstructions. The study will involve a prospective multicenter case series at the Río Hortega University Hospital, where patients who have failed endoscopic retrograde cholangiopancreatography (ERCP) or have surgically-altered anatomy will be assessed. Participants will undergo a clinical evaluation and endoscopic procedure under sedation, with the goal of providing biliary drainage and facilitating further endotherapy. The study will focus on patients who meet specific inclusion criteria and do not have any exclusion factors.
Why it matters
Potential benefit: If successful, this approach could provide a new therapeutic option for patients with benign biliary obstructions who are not candidates for traditional ERCP.
How similar studies have gone: While the approach is gaining acceptance, the specific use of transmural EUS-guided entero-biliary anastomosis in this context is still being evaluated and may be considered novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Consecutive patients ≥ 18 years old. * Benign biliary obstruction. * ERCP failed or where ERCP could not be performed due to surgically-altered anatomy Exclusion Criteria: * • 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
Where it's running
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Hospital Rio Hortega
Valladolid, Spain Recruiting
Study contacts
- Principal investigator: Carlos Maroto Martin, PI — Hospital Rio Hortega
- Study coordinator: Carlos Maroto Martín, PI
- Email: cmarotom@saludcastillayleon.es
- Phone: 983420400
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.