Primary precutting versus conventional over-the-wire sphincterotomy for bile duct access: a prospective randomized study.
Precut is a well-known technique that is used if repeated attempts at common bile duct (CBD) cannulation fail. Opinions on the complication rate of precut are conflicting, however. The aim of the present study was to compare the efficacy and complication rate of precut used as a primary method of CBD access with the efficacy and safety of the conventional technique. During the 19-month study period, consecutive patients who were scheduled for first-time endoscopic sphincterotomy (ES) for a variety of biliary disorders were randomized into two groups: patients in group A underwent conventional wire-guided biliary cannulation followed by ES (with precut being performed only when this failed); in patients in group B precut was used as a primary technique to gain biliary access, followed by wire-guided ES. We used a specially designed, modified Erlangen type of sphincterotome for precutting. A total of 291 patients (100 men, 191 women; mean +/- SD age 65 +/- 17.5 years) were recruited: 146 patients were assigned to group A (conventional approach) and 145 to group B (primary precut approach). The indications for ES were comparable in the two groups. In group A, wire-guided cannulation of the CBD failed in 42 patients. Secondary precut was successful in 41 of these patients, leading to an overall success rate of 99.3 %. In group B, the ES success rate using primary precut was 100 % at the first attempt. The mean time to successful deep CBD cannulation was 8.3 +/- 2.1 minutes in group A and 6.9 +/- 1.8 minutes in group B ( P < 0.001). The incidence of mild to moderate pancreatitis was similar in the two groups (2.9 % in group A vs. 2.1 % in group B, P > 0.05). Mild bleeding occurred in only one patient (from group A) and this was controlled by epinephrine injection. None of the study patients developed severe pancreatitis or perforation. In experienced hands, an approach using primary precut appears to be at least as successful and safe as a conventional approach using guide-wire-based CBD cannulation followed by ES, and might also be a quicker method.