EUS-guided Entero-biliary Anastomosis for Therapeutic Access in Benign Biliary Obstructions

Launched by HOSPITAL DEL RIO HORTEGA · Feb 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help patients with benign biliary obstructions, which are blockages in the bile ducts that can cause pain and other health problems. The focus is on using a method called EUS-guided entero-biliary anastomosis (TEA), which involves placing special stents to help drain bile and make it easier to treat the blockage. This trial is important because it aims to find out if this method is safe and effective for patients who cannot undergo a common procedure called ERCP due to their unique situations.

To be eligible for this trial, participants need to be at least 18 years old and have a benign biliary obstruction. They should also have had difficulties with ERCP or have undergone surgery that altered their anatomy, making ERCP impossible. During the trial, participants can expect to receive this innovative treatment and be monitored for its effectiveness and safety. It's important to note that individuals with certain conditions, like cancer or serious blood clotting issues, and those who are pregnant or unable to follow up may not qualify for the study.

Gender

ALL

Eligibility 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