Publication: Endoscopic sphincterotomy with balloon dilatation versus sphincterotomy alone for common bile duct stones removal
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Date
2022
Authors
Soang, Ooi Jie
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Abstract
Background and objective: Endoscopic sphincterotomy (EST) plus endoscopic papillary large balloon dilatation (EPLBD) have been reported as a valid alternative to EST alone in removing common bile duct (CBD) stone. Our aim of this study is to compare efficacy, and safety of these two groups of patients in removing CBD stone in Hospital Universiti Sains Malaysia (HUSM). Study design and method: This is a prospective single centre randomized single blinded comparative study conducted in HUSM. The primary endpoints for this study are the overall complete stone clearance rate and complication rate, while the secondary outcome for this study are duration of procedure and rate of usage of adjunct. Objective data analysis is conducted using independent sample t-test and Chi2 test. Result: A total of 66 patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) for choledocholithiasis in which is CBD stone who fulfilled inclusion criteria and has no exclusion criteria are recruited in this study. Thirty four patients were allocated to EST plus EPLBD arm (n=34), and 32 patients were in EST alone arm (n=32) using randomization method. For intention to treat, patient from EST alone arm that unable to achieve complete stone clearance will be switched to EST plus EPLBD arm. The overall complete stone removal rate for both groups were comparable (EST plus EPLDB: 100% versus EST alone: 93.8%; p= 0.139). The two patients from EST alone group (6.2%) that unable to achieve complete stone clearance were converted to EST plus EPLBD group for intention to treat and able to achieve complete stone clearance by EST plus EPLBD. For procedural time, both arms are comparable as well (EST plus EPLDB: 15.8 minutes versus EST alone: 15.5 minutes; p= 0.860). Complications such pancreatitis, happened in one patient in EST plus EPLBD arm (EST plus EPLDB: 2.9 % versus EST alone: 0 %; p= 0.328), and bleeding happened in one patient in EST alone arm (EST plus EPLDB: 0 % versus EST alone: 3.1 %; p= 0.299), but it is not statistically significant. No perforation or cholangitis complication happened in both groups. No adjunct usage in both groups as well. Conclusion: Both EST plus EPLBD and EST alone are equally effective, safe and has comparable procedural time in removing CBD stone. Even though both methods are equally effective, EPLBD plus EST is considered as a solution if complete stone clearance unable to achieve via EST alone.
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