EUS-guided procedure for treating benign biliary obstructions
EUS-guided Entero-biliary Anastomosis as Fistulas for Therapeutic Access in Benign Biliary Obstructions Not Accessible by ERCP
Hospital del Rio Hortega · NCT05246657
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital del Rio Hortega (other) |
| Locations | 1 site (Valladolid) |
| Trial ID | NCT05246657 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with benign biliary obstruction who have experienced failure of ERCP or have surgically-altered anatomy.
Not a fit: Patients with malignant biliary obstructions, coagulopathy, or those unable to tolerate sedation will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Valladolid
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cholangiopancreatography, Endoscopic Retrograde