Comparable Long-term Outcomes of 1-Minute vs 5-Minute Endoscopic Papillary Balloon Dilation for Bile Duct Stones.

BACKGROUND & AIMS: Endoscopic papillary balloon dilation (EPBD) is an alternative to endoscopic sphincterotomy for choledocholithiasis. Unlike endoscopic sphincterotomy, EPBD preserves biliary sphincter function, reducing long-term risk of recurrent choledocholithiasis by 50%. Guidelines recommend that duration of EPBD exceeds 2 minutes, to adequately loosen the sphincter and reduce risks of failed stone extraction and post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, it is unclear whether this long duration of EPBD impairs sphincter function and negates the long-term benefit of EPBD. We performed a randomized controlled trial to determine whether long-duration (>1 minute) EPBD increases the risk of subsequent choledocholithiasis and hepatobiliary complications compared with short-duration EPBD (<1 minute).

METHODS

We performed a prospective study of 170 adult patients who underwent ERCP for suspected choledocholithiasis from April 2007 through October 2008 at 2 centers in Taiwan. Patients were randomly assigned to groups that underwent 1-minute (n = 86) or 5-minute (n = 84) EPBD for choledocholithiasis; patients were followed through June 2015. One month after the initial ERCP, patients were examined and liver function tests and abdominal sonographies were performed. Patients were then examined every 3-6 months over a median follow-up period of approximately 7 years. The primary outcome was recurrent choledocholithiasis or acute cholangitis and the secondary outcome was overall hepatobiliary complications. We assessed the effects of EPBD duration by Cox regression.

RESULTS

Thirteen patients (15.1%) developed recurrent choledocholithiasis or acute cholangitis after 1-minute EPBD, and 10 patients (11.9%) developed recurrent choledocholithiasis or acute cholangitis after 5-minute EPBD (P = .352). There was no significant difference between groups in number of hepatobiliary complications (P = .154). Compared with 1-minute EPBD, 5-minute EPBD did not increase risk of the primary outcome (adjusted hazard ratio, 0.76; 95% confidence interval, 0.32-1.82) or the secondary outcome (adjusted hazard ratio, 0.65; 95% confidence interval, 0.31-1.40). Mechanical lithotripsy, performed for failed stone extraction with EPBD at initial ERCP, was a risk factor for primary and secondary outcomes.

CONCLUSIONS

In a randomized controlled trial, we found that the risk of recurrent choledocholithiasis and hepatobiliary complications did not increase with long-duration EPBD (>1 minute), but was increased with mechanical lithotripsy.