Safety and Efficacy of Primary Needle-knife Precut during ERCP Procedure

Abstract

Background: Difficult biliary cannulation during endoscopic retrograde cholangiopancreatography (ERCP) is a major risk factor for post-ERCP pancreatitis (PEP). Needle-knife sphincterotomy (NKS) is commonly used as a rescue technique after failed standard cannulation; however, increasing evidence suggests that early or primary use of NKS may reduce pancreatic duct trauma and procedural complications. This study aimed to evaluate the safety and efficacy of primary needle-knife precut (PNKP) compared with secondary precut in patients with swollen (“pregnant”) papillae.

Patients and Methods: This randomized controlled trial was conducted at Sayed Galal and Damietta Al-Azhar University Hospitals between December 2023 and November 2025. Sixty patients with swollen papillae undergoing ERCP were enrolled and randomized into two groups: Group A (secondary precut after failed standard cannulation; n=40) and Group B (primary precut as the initial cannulation strategy; n=20). Baseline characteristics, procedural outcomes, complication rates, and hospitalization parameters were compared.

Results: Baseline demographic, clinical, and laboratory parameters were comparable between groups. Procedure time was significantly shorter in the primary precut group (18.3 ± 4.8 minutes) compared with the secondary precut group (25.4 ± 6.2 minutes; p < 0.01). Successful biliary-cannulation rates were similar (95% vs. 97.5%; p = 0.51). Post-ERCP pancreatitis occurred more frequently in the secondary precut group (10% vs. 5%; p = 0.03), accompanied by higher unintended pancreatic duct cannulation rates (17.5% vs. 0%; p = 0.01). Post-procedural serum amylase levels were significantly higher in Group A (p = 0.01). Repeat ERCP was required more often in the secondary precut group (5% vs. 0%; p = 0.04), and hospital stay was significantly longer (2.5 ± 1.0 vs. 1.8 ± 0.7 days; p = 0.03). Major complications, including bleeding, perforation, and cholangitis, were low and comparable between groups. 

Conclusion: Early use of needle-knife in patients with swollen papilla was associated with shorter time of procedure, less incidence of post-ERCP pancreatitis and hospital admissions.