Biliary duct stenoses are caused by intrinsic malignant disease of the common bile duct or by compression or infiltration of malignancies of the abdominal organs, i.e. pancreas, liver, stomach, duodenum, etc, or by iatrogenic reasons such as endoscopic biliary stone manipulations, biliary anastomoses or biliary duct reimplantation. In these diseases, a stent can be placed in the biliary duct canal to open it and relieve the obstruction. The Allium Biliary Stent is to be inserted into the biliary duct to allow free flow of biliary fluid from the liver to the duodenum by supporting the obstructed area of the biliary duct lumen, keep it open, and prevent its re-obstruction.
The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent in malignant obstructions of the common bile duct.