Introduction
Common bile duct (CBD) stones are one of the most frequent indications for endoscopic retrograde cholangiopancreatography (ERCP). Endoscopic complete sphincterotomy (EST) followed by balloon or basket extraction is widely considered the gold standard technique for the treatment of CBD stones; being successful in more than 90% of cases with approximately 5% overall rate of adverse events [1]. Endoscopic papillary large balloon dilatation (EPLBD) is an effective technique in treating large common bile duct (CBD) stones. However, the efficacy and safety of EPLBD in the setting of periampullary diverticula (PAD) are prospectively lacking.
Aims & Methods
This study aimed to compare the effectiveness and short-term safety of EPLBD after limited sphincterotomy with those of EST for extracting large CBD stones in the setting of PAD prospectively. Forty-eight patients with large CBD stone(s) > 1 cm were recruited. All patients had a PAD. Before the procedure patients were evaluated by history taking, clinical examination full investigations including proper imaging studies. During the procedure, patients were randomized to either group I; patients treated with EPLBD after limited sphincterotomy, and group II; patients treated with EST. CBD clearance was defined as a single procedure (EPLBD vs EST), single session (no repeat ERCP), and non-assisted (no lithotripsy used) stone extraction. After the procedure patients were hospitalized with clinical, laboratory, and imaging assessment.
Results
Table 1: Univariate regression of the parameters affecting stone extraction
PAD: periampullary diverticulum
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| * significant as P value≤ 0.05
|
| Odds ratio | 95% CI | P value |
| The used technique | 5.92 | 1.32 to 25.3 | 0.009∗ |
| Stone (s) number | 0.62 | 0.17 to 2.25 | 0.468 |
| Stone (s) diameter (mm) | 2.59 | 0.63 to 10.56 | 0.187 |
| Type of PAD | 1.32 | 0.65 to 2.67 | 0.437 |
The overall stone extraction rate in the current study was only 77.3% (n=34). The efficacy of stone extraction was significantly higher in the EPLBD (n= 21,87.5%) group compared to EST (n= 13, 54.17%) group (p = 0.011). The procedure-related adverse events were lower in the EPLBD group compared to the EST group. Pancreatitis was significantly higher in the EST (n=14, 58.33%) group than in the EPLBD (n=3, 12.5%) group (p= 0.001). There were no perforations or case fatalities in either group. The predictors of stone extraction were analyzed using univariate regression (Table 1), and it is noticeable that the used technique was the independent predictor of success in stone extraction (Odds Ratio: 5.92, 95% Confidence Interval: 1.38 to 25.30, p-value = 0.009).
Conclusion
The current practice guidelines of the ESGE and ASGE suggest that for large CBD stones, an EST followed by a large balloon dilatation is preferable to EST alone because combining dilatation with EST improves duct clearance and reduces the need for lithotripsy without adding risk. Our results among PAD patients seem to echo this: the EPLBD approach in comparison to EST yielded higher stone clearance on first attempt even without using lithotripsy by the study design. Hence, based on the current study these existing recommendations can be extrapolated to the PAD population based on our study which is one of the first randomized trials in the specific PAD subgroup.
References
- Zippi M, Traversa G, Pica R, De Felici I, Cassieri C, Marzano C, et al. Efficacy and safety of endoscopic retrograde cholangiopancreatography (ERCP) performed in patients with Periampullary duodenal diverticula (PAD). Clin Ter. 2014;165(4):e291-4.
