EUS-guided Entero-biliary Anastomosis as Fistulas for Therapeutic Access in Benign Biliary Obstructions Not Accessible by ERCP

What this Trial Is About

Researchers are evaluating the feasibility and effectiveness of a technique called EUS-guided entero-biliary anastomosis (TEA) for patients with benign biliary obstruction who cannot be treated using the standard ERCP procedure. This observational study focuses on using transmural covered self-expandable metal stents to create a temporary biliary drainage and access pathway for further biliary endotherapy. The study is being conducted at multiple centers, including the Redo Hortega University Hospital, and aims to include at least 50 patients. The treatment involves creating a connection between the bile ducts and the digestive tract using an endoscopic ultrasound-guided procedure. Under sedation, an echoendoscope is used to locate the bile ducts, which are then punctured and dilated to place a stent, forming the anastomosis. Therapeutic sessions through the stent or fistula follow, which can be done on the same day or later. After completing the necessary treatments or if surgical or percutaneous rescue is needed, the stent is removed endoscopically. Participants will undergo clinical assessments, including physical exams and blood tests, before and after the procedure. Follow-up visits occur 24 hours, 7 days, 30 days, 3 months, and 6 months after stent removal, either in-person or by phone. During these visits, clinicians will monitor clinical status, liver function, and any complications. All collected data will be anonymized and securely stored. The primary outcome measure is clinical success assessed over one year.

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