Title of article :
Use of 4-Fr versus 6-Fr Nasobiliary Catheter for Biliary Drainage: A Prospective, Multicenter, Randomized, Controlled Study
Author/Authors :
Tsuboi, Tomofumi Department of Gastroenterology and Metabolism - Applied Life Science - Institute of Biomedical & Health Science - Hiroshima University - Hiroshima, Japan , Serikawa, Masahiro Department of Gastroenterology and Metabolism - Applied Life Science - Institute of Biomedical & Health Science - Hiroshima University - Hiroshima, Japan , Sasaki, Tamito Department of Gastroenterology and Metabolism - Applied Life Science - Institute of Biomedical & Health Science - Hiroshima University - Hiroshima, Japan , Ishii, Yasutaka Department of Gastroenterology and Metabolism - Applied Life Science - Institute of Biomedical & Health Science - Hiroshima University - Hiroshima, Japan , Fujimoto, Yoshifumi Department of Gastroenterology & Hepatology - JA Hiroshima General Hospital - Hiroshima, Japan , Yamaguchi, Atsushi Department of Gastroenterology - National Hospital Organization - Kure Medical Center and Chugoku Cancer Center - Kure - Hiroshima, Japan , Ishigaki, Takashi Department of Gastroenterology - National Hospital Organization Higashihiroshima Medical Center - Higashihiroshima, Japan , Shimizu, Akinori Department of Gastroenterology and Metabolism - Applied Life Science - Institute of Biomedical & Health Science - Hiroshima University - Hiroshima, Japan , Kurihara, Keisuke Department of Gastroenterology and Metabolism - Applied Life Science - Institute of Biomedical & Health Science - Hiroshima University - Hiroshima, Japan , Tatsukawa, Yumiko Department of Gastroenterology and Metabolism - Applied Life Science - Institute of Biomedical & Health Science - Hiroshima University - Hiroshima, Japan , Miyaki, Eisuke Department of Gastroenterology and Metabolism - Applied Life Science - Institute of Biomedical & Health Science - Hiroshima University - Hiroshima, Japan , Chayama, Kazuaki Department of Gastroenterology and Metabolism - Applied Life Science - Institute of Biomedical & Health Science - Hiroshima University - Hiroshima, Japan
Abstract :
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.
Keywords :
4-Fr , Randomized , Biliary , NBD