S2223 The Effectiveness of Forceps-Assisted Cannulation for Difficult Cannulation During ERCP: Results of the SOCCER Randomized Controlled Trial

Introduction: Forceps-assisted cannulation has been reported to facilitate difficult papillary cannulation during ERCP, especially in the context of abnormal papillary anatomy or associated papillary diverticula. We performed a randomized, controlled trial to evaluate if forceps-assisted cannulation improves cannulation success rates, reduces the incidence of difficult cannulations, and decreases the risk of post-ERCP pancreatitis (PEP). Methods: 152 patients with difficult papillary cannulation during ERCP were randomized to cannulation with or without forceps. Difficult cannulation was defined as: papilla in/on the rim of a diverticulum, difficult cannulation (defined as 5 or more attempts, 5 or more minutes, or 2 or more unintended PD wire passages), redundant tissue overlaying the papilla, or a type 2, 3, or 4 papilla. The primary clinical outcome was rate of successful cannulation. Results: Seventy patients underwent forceps-assisted cannulation and 81 did not use forceps. Forceps patients were younger (62 vs 68 years P = 0.009), but otherwise baseline demographics, ERCP indication, trainee involvement and papilla classification were similar with failed initial cannulation the most common reason for enrollment. 100% of patients in the forceps-assisted group vs 83.9% in the no forceps group (P < 0.001) underwent successful cannulation. All 13 patients in the no forceps group who crossed over to the forceps group had successful cannulation. While not statistically significant, the difficult cannulation rate (57.1 vs 69.1, P = 0.132) was higher in the no forceps group and the PEP rate was low in both groups (5.7 vs 3.7, P = 0.705). The no forceps group had significantly more cannulation attempts following randomization compared to forceps (14.0 vs 8.3, P = 0.026). Forceps-assisted resulted in decreased cannulation time after randomization than no forceps, though this value failed to reach significance (9.1 vs 13.1 minutes, P = 0.081). Most subjects had type 1 papillae (72.2%, 109/151). The incidence of the other papillae was: 7.3% (11/151) type 2, 14.5% (22/151) type 3, and 6.0% (9/151) type 4. Forceps had significantly higher cannulation rates among type 1 compared to no forceps (100% vs 84%, P = 0.005). Forceps also had higher success rates in type 2 (100% vs 60%, P = 0.182) and type 3 (100% vs 88%, P = 0.364), though these values did not reach significance. Conclusion: Using forceps-assisted technique to overcome difficult cannulation improves ERCP cannulation success rates.