Preliminary Results from Prospective Randomized Single Blinded Trial Comparing the Performance Characteristics of a Short-Wire (FUSION) and Standard Long-Wire (DASH) ERCP Device Systems

Preliminary Results from Prospective Randomized Single Blinded Trial Comparing the Performance Characteristics of a Short-Wire (FUSION) and Standard Long-Wire (DASH) ERCP Device Systems Ali Fazel, Lukasz Kowalczyk, Koorosh Moezardalan, Chris Forsmark, Peter Draganov Background: The traditional long-wire ERCP device system requires a substantial amount of time for device exchanges. The successful performance of the procedure is highly dependent on the skill of the assistant manipulating the wire and various devices. A new short-wire system may provide for faster device exchanges, decreased fluoroscopy time, and the ability of the physician to control the wire. Methods: The study was approved by our institutional review board. Consecutive patients were prospectively randomized to undergo ERCP with a traditional long-wire system (DASH, Cook Medical) or the new short-wire device system (FUSION, Cook Medical). All ERCPs were done by one experienced endoscopist who was unaware of the study end points throughout the trial. An independent observer, not involved in the procedure, was recording the measured outcomes. The outcomes were compared using two-sample t-test. Results: 46 patients were randomised (25 DASH, 21 FUSION). The average time to achieve the predetermined end-points is listed in the table.A trend towards shorter time to perform various standard ERCP maneuvers with the FUSION system was seen with all measured outcomes. The difference reached statistical significance for the time required to insert biliary stents (p Z 0.001). Conclusion: A preliminary report from this prospective randomized trial shows that the new short-wire FUSION device system appears superior to the traditional long-wire ERCP system. A trend towards shorter total procedure time and shorter time to perform various standard ERCP maneuvers was observed. In particular, there seems to be a significant advantage in stent insertion times, probably related to the ability to perform intraductal exchange. The ongoing enrollment of subjects in this trial will be better able to compare the performance of the short and long wire device systems.