Endoscopic Papillary Large Balloon Dilatation for Difficult Common Bile Duct Stones: Clinical, Radiological, Laboratory, and Anatomical Predictors of Procedural Success: A Prospective Pilot Clinical Trial.

Background: Endoscopic papillary significant balloon dilatation (EPLBD) has become a convenient method of treating challenging common bile duct (CBD) stones, but predictors of success remain unresolved. Aim: To analyse clinical, laboratory, radiological, and anatomical effects on a single session of CBD stone clearance with EPLBD. Methods: It was a Prospective pilot clinical trial that enrolled 25 adult patients with tough CBD stones who had undergone conventional ERCP procedures in vain. Limited biliary sphincterotomy and EPLBD with 12-18 mm balloons were done on all patients. Clinical, biochemical, radiological, and anatomical parameters were evaluated prior to the procedure. The main result was the total clearance of CBD in one session. The secondary outcomes were complications, biliary stenting necessity, duration of procedures, and length of stay. Results: The complete clearance of the stone through a single session of complete CBD was reported in 16 out of 25 patients (64%). The complications associated with the procedure were minimal and affected three patients (12%), and were mild in nature; there were no cases of perforation or excessive bleeding. Multi-variable analysis revealed that the independent variables associated with procedural success were larger CBD diameter (OR 1.48 per mm increase, p = 0.012), better distal CBD angulation 135° and above (OR 3.92, p = 0.038), and large balloon size (OR 1.67 per mm increase, p = 0.008). There was no statistically significant correlation between demographic variables and laboratory baseline parameters and EPLBD outcomes. Conclusion: EPLBD is safe and can be highly applied to challenging CBD stones. Some of the main determinants of success are anatomical and procedural factors, and not clinical or laboratory variables.