Biliary cannulation with contrast and guide-wire versus exclusive guide-wire: A prospective, randomized, double-blind trial.

BACKGROUND: The use of exclusive guide-wire cannulation (e-GW) instead of contrast injection reduces post-ERCP pancreatitis (PEP) and pre-cutting and increases cannulation rate. Herein, we intend to compare e-GW with the hybrid technique (GW-C and/or contrast injection). METHODS: Prospective single-center randomized comparative study, which included all patients referred to ERCP to our unit. Patients with non-naïve papilla; previous ERCP; direct infundibulotomy, ampullectomy, Billroth II gastrectomy or pancreatic sphincterotomy and patients lost to follow up were excluded. RESULTS: 727 consecutive patients were assessed. Of these, 588 naïve papilla patients were included and randomized to receive e-GW (n = 299) or GW-C (n = 289) for selective biliary cannulation. The mean age was 60.3 years and 60.5% were women. PEP occurred in 15(5%) cases in e-GW group and 9(3.1%) in the GW-C group (p = 0.29). Time to reach deep cannulation was faster in the latter group (75% < 5 min vs. 50.2% < 5 min, p<0.001). > 10 min until cannulation was observed in 21% vs. 10% of the ERCPs (groups e-GW and GW-C, respectively, p < 0.001). Total ERCP time was also shorter in the GW-C group (12 vs. 10 min; p < 0.001). Pre-cut (23.8 vs.11.8%, p < 0.001) and pancreatic sphincterotomy as a pre-cut technique (15.8 vs. 5.6%, p < 0.001) were used more frequently in the e-GW group. CONCLUSIONS: Compared to exclusive G-W- assisted biliary cannulation, the hybrid technique did not significantly reduce the PEP rate, however it promoted faster cannulation and, consequently, reduced the total procedure time and the use of pre-cut techniques.