Boston Scientific Corporation, a global medical technology leader, has enrolled first patient in a clinical investigation evaluating the use of WallFlex Biliary RX Stent, a self-expanding metal stent (SEMS), as a bridge to surgery compared with the absence of drainage prior to surgery. This multi-centre, prospective, randomized study is expected to enroll 294 patients at leading hospitals in Australia, Belgium, Canada, France, Hong Kong, India, Italy and Japan.
The first patient was enrolled by Professor Jacques Deviere of Erasme Hospital in Brussels.
"Patients with pancreatic or periampullary cancer often have high levels of bilirubin, which adversely affect their liver, cardiovascular and renal functions," said Professor Deviere. "These patients often have impaired immune response and clotting, which in turn could negatively impact the outcome of their surgical resection. Preoperative biliary drainage could potentially reverse these factors and therefore result in an improved outcome of the surgery. Published data regarding plastic stent drainage prior to surgical resection have been unfavourable and physicians are increasingly turning to self-expanding metal stents for preoperative drainage where necessary due to their large diameter. We expect this study to provide us with important data on the safety and effectiveness of this approach compared with proceeding to surgery without biliary drainage."
SEMS have long been considered the standard of care for the palliative treatment of malignant biliary strictures. This study evaluates the benefits of using SEMS in preoperative settings, with an objective of documenting clinical safety and effectiveness as compared to the standard, direct-to-surgery approach.
"Boston Scientific is committed to advancing science through investment in robust clinical research, while delivering innovative technologies designed to improve quality of life for patients," said David Pierce, president, Endoscopy, Boston Scientific. "The results of this study may indicate that using SEMS pre-operatively for biliary drainage could result in better patient outcomes and prove to be more cost effective for physicians and hospitals."
The study includes WallFlex Biliary Fully Covered and Uncovered Metal Stents. The WallFlex Biliary Fully Covered Stent has a silicone polymer Permalume Coating designed to reduce the potential for tumour/ tissue ingrowth, and an integrated retrieval loop for removing or repositioning the stent in the event of incorrect placement during the initial procedure or for removal from benign strictures up to one year after placement. The stent is constructed of braided, platinum-cored Nitinol wire (Platinol Wire) and features three key components: radial force to help maintain duct patency and resist migration, flexibility to aid in conforming to tortuous anatomies and full-length radiopacity to enhance stent visibility under fluoroscopy.
WallFlex Biliary Stents – Fully Covered, Partially Covered and Uncovered – are available in the United States and are only indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The WallFlex Biliary Stents are not indicated in the United States for use in preoperative malignant biliary strictures nor for use in benign biliary strictures. The safety and effectiveness of the stent for use in the vascular system have not been established.
The WallFlex Biliary Stents are CE Marked for use in the palliative treatment of biliary strictures produced by malignant neoplasms and for treatment of benign biliary strictures.
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