Endoscopic nasobiliary drainage for obstructive jaundice using either a 5 Fr or 7 Fr catheter: a prospective, randomized trial

BACKGROUND The influence of size on the effectiveness of nasobiliary catheters has not yet been studied. We compared biliary drainage effectiveness and procedure-related discomfort and adverse events in 5 French (Fr) and 7 Fr nasobiliary catheters. METHODS We prospectively studied 100 patients undergoing endoscopic biliary drainage for obstructive jaundice, who were randomly allocated to a 5 Fr or 7 Fr nasobiliary catheter group. As the primary endpoint, the effectiveness was evaluated by the serum total bilirubin decreasing rate and the success rate of jaundice relief. As the secondary endpoint, the degree of discomfort was investigated using a questionnaire survey after catheter removal. RESULTS The bilirubin decrease rate was significantly higher in the 7 Fr catheter group than in the 5 Fr group (53.0 ± 21.4% vs 40.5 ± 29.9%, respectively; P = 0.019). The success rate of jaundice relief tended to be higher in the 7 Fr catheter group, although the difference was not statistically significant (98% vs 88%, respectively; P = 0.056). The questionnaire survey demonstrated that total discomfort was significantly greater in the 7 Fr group (3.9 ± 1.5 vs 3.2 ± 1.4, respectively; P = 0.018). Larger-diameter catheters tended to increase difficulty in eating, although the difference between the groups was not statistically significant. CONCLUSIONS 7 Fr nasobiliary catheters are recommended for patients requiring rapid and reliable relief of obstructive jaundice. However, because they can cause greater discomfort, 5 Fr nasobiliary catheters are preferred in other settings. TRIAL REGISTRATION On July 1, 2012; UMIN000008288 (Japan Primary Registries Network).