Basket versus balloon extraction for choledocholithiasis : a single center prospective single-blind randomized study

Background and study aims: endoscopic retrograde cholangio- pancreatography (ERCP) is essential when dealing in patients with choledocholithiasis. However, the proper extraction device selection is, often, a matter of the endoscopists’ preference. We conducted a single center prospective randomized controlled study to access success rates for basket versus balloon catheters for small stones.

Patients and methods: in our non-inferiority study, 180 patients with bile duct stones were randomized in a basket and a balloon catheter group. Inclusion criteria were fluoroscopically bile duct stones ≤10mm in diameter and a common bile duct diameter ≤15mm. The primary endpoint was the rate of complete bile duct clearance for each method. Secondary endpoints included time completed and amount of radiation dose recorded in each ERCP session, as well as any reported adverse events.

Results: balloon was non-inferior to basket stone extraction (OR 3.35, 95% CI 1.12-10.05, p=0.031). Complete clearance was achieved in 69 out of 82 patients (84.1%) in the basket catheter group versus 79 out of 84 patients (94%) in the balloon catheter group (p=0.047) ; this seems to be especially true for patients with few stones and of small size (≤2 stones, p=0.043 and stone diameter ≤5mm, p=0.032). Complete stone clearance in the basket group patients took longer than that in the balloon group (4.52 and 4.06 min, respectively, p=0.015). Higher median radiation doses for stone clearance were recorded in the basket versus the balloon catheter group (1534.43 Gy versus 1245.45 Gy, p=0.023).

Conclusions: our study showed that balloon was non-inferior to basket stone extraction.

Keywords: ERCP, choledocholithiasis, balloon, basket, clearance.