Despite its relative safety (in comparison with surgery), and undoubted role in many clinical circumstances, biliary sphincterotomy is the most dangerous procedure routinely performed by endoscopists. Complications occur in about 10% of patients; 2 to 3% have a prolonged hospital stay, with a risk of dying. This document is an attempt to provide guidelines for prevention and management of complications, based on a workshop of selected experts, and a comprehensive review of the literature. We emphasize particularly the importance of specialist training, disinfection, drainage, and collaboration with surgical colleagues.