Background Basket and balloon are both commonly used instruments for the clearance of pancreatic duct stones in CP patients under Endoscopic retrograde cholangiopancreatography (ERCP). However, the choice of basket or balloon for stone clearance usually depends on the subjective decisions of the endoscopists. We therefore conducted a single-blind, randomized controlled trial to compare the efficacy of basket and balloon in the clearance of pancreatic duct stones under ERCP.

Methods Painful CP patients admitted to the Gastroenterology Department of Changhai Hospital from June 2022 to February 2023, who had ≥ 3 main pancreatic duct (head/body) stones with a diameter of ≤ 5mm, were randomly assigned to the basket group (basket removal of pancreatic duct stones) and the balloon group (balloon removal of pancreatic duct stones). The primary endpoint was the complete clearance rate of the main pancreatic duct stones.

Results A total of 104 patients were included in the study according to inclusion and exclusion criteria; 5 patients were excluded after randomization. Relevant data showed that the complete clearance rate was 76.5% (39/51) in the basket group and 18.8% (9/48) in the balloon group (p<0.001). The average time taken on stone removal via basket and balloon was 554.98 seconds and 246.88 seconds, respectively (p<0.001). In addition, ERCP-related complications mainly included acute pancreatitis, bleeding, and infection. The overall incidence rate of ERCP-related complications in the basket and balloon group was 7.8% and 14.6%, respectively.

Conclusions In terms of the clearance of multiple pancreatic duct stones, the complete clearance rate via the basket was significantly higher than that of the balloon. In contrast, the average time of stone removal via the basket was significantly longer than that of the balloon. For patients with mass pancreatic duct stones or severe pancreatic duct distortion, it was of great importance to prevent the occurrence of basket incarceration.