Abstract
Background. Endoscopic retrograde cholangiopancreatography (ERCP) is an established treatment modality for bile duct disorders, but patients have a risk of post-ERCP pancreatitis (PEP) and biliary sepsis. Aim. To evaluate the effectiveness and safety of pancreatic stent for prophylaxis of PEP and biliary sepsis in high-risk patients with complicating common bile duct (CBD) disorders. Methods. Two hundred and six patients with complicating confirmed or suspected CBD disorders were randomly assigned to receive ERCP with pancreatic stenting (experimental group) or without stenting (control group). Primary outcome measure was frequency of PEP, and secondary outcome measures included operative time, blood loss, postoperative recovery times, and other ERCP-associated morbidities. Results. Baseline age, sex, CBD etiology, concomitant medical/surgical conditions, cannulation difficulty, and ERCP success were comparable between the two groups (all P > 0.05). Compared to the control group, the experimental group had a significantly lower frequency of PEP (7.7% versus 17.7%, P < 0.05) and positive bile microbial culture (40.4% versus 62.7%, P < 0.05). However, the two groups were similar in operative time, blood loss, postoperative recovery times, and other ERCP-associated morbidities (all P > 0.05). Conclusions. Pancreatic stenting can reduce the occurrence of PEP and biliary sepsis in high-risk patients with complicating CBD disorders but does not increase other ERCP-associated morbidities. This trial is registered with the Chinese Clinical Trial Registry (registration identifier ChiCTR-OCH-14005134).