EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent

This is a prospective feasibility study enrolling patients suffering from malignant biliary obstruction with failed or anticipated difficult ERCP. Consecutive patients satisfying the inclusion criteria would be recruited.

EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent. The MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) is a novel device designed for hepaticogastrostomy. The stent is a partially covered metal stent made by nitinol covered with silicone. One end of the stent is uncovered and designed for placement in the intrahepatic ducts. The other end has a self-folding design that creates a flange and prevents migration of the stent outside the stomach. The stent diameter is either 8 or 10mm and the length can be 6,8,10 or 12cm long.

Outcome parameters include safety, technical and clinical success

Inclusion criteria

• >= 18 years of age
• Anatomically feasible for EUS-guided hepatico-gastrostomy
• Patients with clinical symptoms and/or signs of extrahepatic biliary obstruction (jaundice, biliary-type pain, cholangitis)
• Patients with unsuccessful ERCP (failed ERCP, anticipated difficult ERCP or high risk for pancreatitis)
• Written informed consent (and assent when applicable) obtained from subject.

Exclusion criteria

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• Coagulopathic patients (INR>1.5, platelets <50,000)