Is endoscopic papillary large balloon dilatation without endoscopic sphincterotomy effective?

AIM: To evaluate the safety and efficacy of endoscopic papillary large balloon dilatation (EPLBD) without endoscopic sphincterotomy in a prospective study.

METHODS: From July 2011 to August 2013, we performed EPLBD on 41 patients with naïve papillae prospectively. For sphincteroplasty of EPLBD, endoscopic sphincterotomy (EST) was not performed, and balloon diameter selection was based on the distal common bile duct diameter. The balloon was inflated to the desired pressure. If the balloon waist did not disappear, and the desired pressure was satisfied, we judged the dilatation as complete. We used a retrieval balloon catheter or mechanical lithotripter (ML) to remove stones and assessed the rates of complete stone removal, number of sessions, use of ML and adverse events. Furthermore, we compared the presence or absence of balloon waist disappearance with clinical characteristics and endoscopic outcome.

RESULTS: The mean diameters of the distal and maximum common bile duct were 13.5 ± 2.4 mm and 16.4 ± 3.1 mm, respectively. The mean maximum transverse-diameter of the stones was 13.4 ± 3.4 mm, and the mean number of stones was 3.0 ± 2.4. Complete stone removal was achieved in 97.5% (40/41) of cases, and ML was used in 12.2% (5/41) of cases. The mean number of sessions required was 1.2 ± 0.62. Pancreatitis developed in two patients and perforation in one. The rate of balloon waist disappearance was 73.1% (30/41). No significant differences were noted in procedure time, rate of complete stone removal (100% vs 100%), number of sessions (1.1 vs 1.3, P = 0.22), application of ML (13% vs 9%, P = 0.71), or occurrence of pancreatitis (3.3% vs 9.1%, P = 0.45) between cases with and without balloon waist disappearance.

CONCLUSION: EST before sphincteroplasty may be unnecessary in EPLBD. Further investigations are needed to verify the relationship between the presence or absence of balloon waist disappearance.