Papillary fistulotomy vs conventional cannulation for endoscopic biliary access: A prospective randomized trial.

AIM: To compare the cannulation success, biochemical profile, and complications of the papillary fistulotomy technique vs catheter and guidewire standard access.

METHODS: From July 2010 to May 2017, patients were prospectively randomized into two groups: Cannulation with a catheter and guidewire (Group I) and papillary fistulotomy (Group II). Amylase, lipase and C-reactive protein at T0, as well as 12 h and 24 h after endoscopic retrograde cholangiopancreatography, and complications (pancreatitis, bleeding, perforation) were recorded.

RESULTS: We included 102 patients (66 females and 36 males, mean age 59.11 ± 18.7 years). Group I and Group II had 51 patients each. The successful cannulation rates were 76.5% and 100%, respectively ( P = 0.0002). Twelve patients (23.5%) in Group I had a difficult cannulation and underwent fistulotomy, which led to successful secondary biliary access (Failure Group). The complication rate was 13.7% (2 perforations and 5 mild pancreatitis) vs 2.0% (1 patient with perforation and pancreatitis) in Groups I and II, respectively ( P = 0.0597).

CONCLUSION: Papillary fistulotomy was more effective than guidewire cannulation, and it was associated with a lower profile of amylase and lipase. Complications were similar in both groups.