Use of 4-Fr versus 6-Fr Nasobiliary Catheter for Biliary Drainage: A Prospective, Multicenter, Randomized, Controlled Study.

Background and Aim. Endoscopic nasobiliary drainage (NBD) effects according to diameter remain unclear. We aimed to assess the drainage effects of the 4-Fr and 6-Fr NBD catheters. Methods. This prospective, multicenter, randomized, controlled study was conducted at Hiroshima University Hospital and related facilities within Hiroshima Prefecture. Endoscopic retrograde cholangiopancreatography (ERCP) in 246 patients revealed acute cholangitis, obstructive jaundice, and/or extrahepatic cholestasis; 4-Fr or 6-Fr NBD catheters were randomly allocated and placed in these patients. The primary endpoint was the efficacy of NBD based on the technical success rate and clinical success (rates of change in blood test and amount of bile output). Secondary endpoints included the spontaneous catheter displacement rate and nasal discomfort. Results. The technical success rate and clinical success did not differ significantly between groups. No spontaneous catheter displacement was noted in either group. Nasal discomfort due to catheter placement was significantly lower in the 4-Fr group versus the 6-Fr group (24 h after ERCP: 2.4 versus 3.5 cm, P = 0.005; 48 h after ERCP: 2.2 versus 3.1 cm, P = 0.01). Conclusion. The 4-Fr NBD catheter was not inferior to 6-Fr NBD catheter in terms of clinical success; the 4-Fr NBD catheter was useful to reduce nasal discomfort.