Endoclip papillaplasty (ECPP) versus limited EST plus EPLBD for a decrease in recurrent choledocholithiasis: a prospective cohort study

Background and aims Limited EST plus EPLBD has been widely used for the therapy of large CBDS; however, long-term complication-relevant studies suggested that it damaged the function of the sphincter of Oddi (SO) and resulted in recurrent choledocholithiasis. Thus, we designed Endoclip papillaplasty (ECPP) and previous studies have shown that it successfully restored the function of SO. In this study, we designed a prospective cohort and aimed to verify the safety and effectiveness of ECPP. Methods Eligible patients were divided into the ECPP group and the limited EST plus EPLBD group based on papillary morphology and the ratio of maximum size of stones to length of intramural segments of CBD. All participants in the ECPP group received endoscopy at 3 weeks to retrieve the biliary stent, perform SOM, and were divided into grade A and grade B based on the healing grade of SO. All patients were followed up every 6 months until recurrent choledocholithiasis, patient death, or at the 36-month follow-up end. The primary outcome was the incidence of recurrent choledocholithiasis. The secondary outcomes included mechanical lithotrip usage and adverse events. Results The incidences of recurrent choledocholithiasis in the ECPP group and limited EST plus EPLBD group were 13.6 and 22.1%, respectively ( P = 0.204). The ECPP-A group had a lower incidence of recurrent choledocholithiasis than the limited EST plus EPLBD groups (5.1 vs. 22.1%, P = 0.020*), and certified the function of SO successfully restored in the ECPP-A group. Conclusion The ECPP-A group had a decrease in recurrent choledocholithiasis, and ECPP was safe and effective for CBDS.