Analysis of the effectiveness and safety of endoscopic retrograde cholangiopancreatography versus percutaneous transhepatic biliary drainage in severe acute cholangitis caused by common bile duct stones.

The objective of the study was to explore the effectiveness and safety of endoscopic retrograde cholangiopancreatography (ERCP) compared to percutaneous transhepatic biliary drainage (PTBD) in treating severe acute cholangitis (AC) caused by common bile duct stones. This was a prospective, randomized controlled trial conducted between May 2021 and May 2024. A total of 126 patients diagnosed with severe acute cholangitis due to common bile duct stones, classified according to the Tokyo Guidelines 2018 (TG18), were selected. They were randomly divided into an ERCP group (n = 63) and a PTBD group (n = 63). Randomization was performed using a computer-generated sequence and allocation was concealed using sealed opaque envelopes. Operators could not be blinded, but outcome assessors and data analysts were blinded to group allocation. We compared therapeutic effects, procedural and recovery parameters, and incidence of complications. Levels of inflammatory factors and pain intensity were statistically analyzed. The primary end point was the length of hospital stay. Secondary end points included time to definitive stone clearance, time to first ambulation, procedure time, time to return of bowel function, changes in inflammatory markers, pain scores, therapeutic efficacy, patient-reported outcomes, and complication rates. There were no statistically significant differences in procedure time, estimated intraoperative blood loss, and time to return of bowel function between the two groups (P > 0.05). However, the ERCP group had significantly shorter times for first ambulation and hospital stay compared to the PTBD group (P < 0.001 for both). Definitive stone clearance during the initial procedure was achieved in 92.1% (58/63) of ERCP patients versus 0% in the PTBD group, resulting in a significantly shorter time to complete stone clearance in the ERCP group (2.1 ± 1.5 vs. 9.8 ± 3.4 days, P < 0.001). Initial therapeutic efficacy and technical success rates were high and similar between groups (98.4% vs. 96.8%). Both interventions significantly reduced inflammatory markers and pain scores, with no inter-group differences. However, patients in the PTBD group reported significantly higher drain-related discomfort at 72 h (P < 0.001). The total complication rates were similar (7.94% vs. 9.52%, P > 0.05). For severe acute cholangitis caused by common bile duct stones, ERCP provides a more efficient single-stage treatment, leading to faster definitive stone clearance, shorter recovery times, and better patient-reported comfort compared to the multi-stage approach required with initial PTBD, without an increase in complications.