Prospective randomized comparison of short-access mother-baby cholangioscopy versus direct cholangioscopy with ultraslim gastroscopes

Background Mother-baby technologies, the criterion standard for cholangioscopy, have several limitations. A novel, short-access, mother-baby (SAMBA) system may improve this technique. Direct cholangioscopy (DC) was recently developed as an alternative to mother-baby cholangioscopy. Objective Comparison of success rates with SAMBA and DC. Design Single-center, randomized, controlled trial. Setting Academic tertiary-care referral center. Patients Sixty patients with suspected cholangiopathies randomized to either SAMBA (n = 30) or DC (n = 30). Intervention Cholangioscopy under deep sedation. Main Outcome Measurements Technical success rate of diagnostic or therapeutic procedure. Results A total of 24 and 21 diagnostic procedures were performed in the SAMBA and DC groups, respectively. There were no significant differences in the overall technical success rates between SAMBA (90.0%) and DC (86.7%) ( P = 1.0). There was better correlation between the endoscopic prediction and histologic findings in DC ( P = .013). Procedure times were shorter in DC ( P < .03). In patients without significant stenoses, SAMBA allowed intrahepatic bile duct exploration in all cases, compared with 10.5% of cases in DC ( P < .01). No differences regarding adverse event rates between the groups occurred (10.0% both groups). Limitations Small sample size. Heterogeneous indications for cholangioscopy. DC requires advanced skills of the endoscopist. The study is not replicable. Conclusion SAMBA and DC offer high technical success rates for diagnostic and therapeutic interventions. The advantages of DC consist of superior imaging, shorter total procedure time, and a wider working channel for adequate tissue sampling. SAMBA is better than DC with regard to intraductal stability and accessibility of the intrahepatic bile ducts.