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.