Efficacy and safety of endoscopic papillary balloon dilation for the removal of bile duct stones: Data from a "real-life" multicenter study on Dilation-Assisted Stone Extraction.

AIM: To report data on Dilation-Assisted Stone Extraction (DASE) use in clinical practice and its efficacy and safety trough three Italian referral centers for biliopancreatic diseases treatment.

METHODS: From January 2011 to December 2015 we collected data on 120 patients treated with DASE. Technical success was obtained when the endoscopist was able to place the balloon trough the papilla inflating the balloon until the final diameter for an adequate time (at least 30 s). Clinical success was obtained after complete stone removal (no remaining stones were visible at the cholangiogram).

RESULTS: Forty-nine male (40.8%) and 71 female (59%) were enrolled. The mean age was 67.8 years ± 15.7. The mean common bile duct (CBD) dilation was 19.2 mm ± 3.9 and the mean size of stones 15.8 ± 2.9. DASE was applied as first approach in 38% (62% after initial failure of stones extraction). Technical and clinical success was of 91% and 87% respectively. In those in which DASE failed alternative treatment were adopted. After DASE 18% of patients experienced a complication (bleeding 9%, pancreatitis 8%, perforation 0.8%). At univariable analysis, elective endoscopic retrograde cholangiopancreatography ( P = 0.031), DASE as first approach ( P = 0.032), and cannulation of major papilla followed by guidewire insertion ( P = 0.004) were related to low risk of complications. Pre-cut was related to an increased risk of complications ( P = 0.01).

CONCLUSION: DASE allowed a higher first-session success rate and can be consider a valid alternative to endoscopic sphincterotomy not only for bigger CBD stones.