Inoperable Tumors of the Bile Duct Clinical Trial
Official title:
A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.
This is a prospective randomized trial conducted at 4 large teaching hospitals (Brigham and Women's Hospital, Massachusetts General Hospital, and Boston Medical Center, Boston, Massachusetts, and Mayo Clinic, Rochester, Minnesota). Inclusion criteria are (1) age ≥18 years; (2) malignant distal (≥1 cm distal to the biliary hilum) biliary obstruction amenable to stent placement; and (3) not a candidate for curative surgical resection due to tumor stage, operative risk, or patient wishes. Exclusion criteria are (1) inability to obtain informed consent, (2) contraindication to ERCP, (3) prior biliary SEMS placement, and (4) prior biliary surgery. Malignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or EUS. Written informed consent is obtained from each of the enrolled patients. The study is approved by the Institutional Review Boards at each of the participating centers. ;