Prospective randomized comparison of stonetome combination catheter versus conventional endoscopic clearance of common bile duct.

Abstract

To assess the therapeutic efficacy and performance characteristics of a novel cannula that has recently become available for clearance of the common bile duct (CBD), combining a sphincterotome and retrieval balloon in a single instrument, and to compare it with the conventional approach. Seventeen consecutive patients with signs of biliary obstruction were prospectively randomized to undergo evaluation and clearance of the CBD by combination catheter (Stonetome, Microvasive) or conventional sphincterotomy (Ultratome) with separate balloon sweep. In all cases, three sweeps of the CBD were made with an 11.5-mm retrieval balloon after sphincterotomy. Fluoroscopy time was measured, as was total time from initiation of sphincterotomy to removal of endoscope from the patient. The same endoscopist performed all procedures. Patient groups were matched with regard to age, gender, proportion with prior cholecystectomy, CBD diameter, and stone size. Patients were successfully treated by either approach. Use of the Stonetome combination catheter reduced mean fluoroscopy time by 52% (from 3.1 +/- 0.6 to 1.5 +/- 0.2 min), mean total time by 57% (from 11.3 +/- 2.2 to 4.9 +/- 1.1 min), and dosage of midazolam used for conscious sedation. The new combination catheter allows the elimination of one step in exchanging the sphincterotome for a retrieval balloon after sphincterotomy. Its efficacy in clearing the CBD is equal to that of our conventional approach. Use of the combined approach should minimize the risk of losing cannulation, reduce fluoroscopic exposure, and improve the overall efficiency of the procedure.