The safety sphincterotome: the device, the technique and preliminary results.

BACKGROUND AND STUDY AIMS

Endoscopic sphincterotomy is a widely used and safe procedure for the management of common bile duct stones, but little attention has been paid to the design of the sphincterotome and its influence upon risk of sphincterotomy. This study was undertaken to evaluate a sphincterotome, designed to incorporate known and original aspects which may contribute to safety.

PATIENTS AND METHODS

144 patients with bile duct stones were evaluated in an open prospective study of the use of the sphincterotome in performing endoscopic sphincterotomy. Evaluation included post-sphincterotomy complications, 30-day morbidity and mortality and effective duct clearance.

RESULTS

Only one complication (0.7%) occurred in the group of 144 patients. Duct clearance of stones was ultimately achieved in 94%.

CONCLUSIONS

Whilst more experience is necessary using the sphincterotome in the manner described, the absence of significant complications in all but one patient appears to support the philosophy behind the design of the sphincterotome.