The online version of this article (doi:10.1186/1471-230X-14-161) contains supplementary material, which is available to authorized users.
The authors declare that they have no competing interests.
Study conception and design: TF, AN, and NM. Performed the procedure: KK, SW, KH, and KK. Randomization and statistical analysis of the data: TF, HS. Draft and revision of the manuscript for important intellectual content: TF, KH, KK, NM. All authors read and approved the final manuscript.
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.
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.
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.
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.
On July 1, 2012; UMIN000008288 (Japan Primary Registries Network).
Additional file 2: Figure S2: The bilirubin decrease rate in each primary disease. The bilirubin decrease rate in the 5 Fr or 7 Fr catheter groups was evaluated separately for each primary disease. The bilirubin decrease rate was higher in the 7 Fr catheter group in every primary disease. The blue and red lines represent 5 Fr and 7 Fr catheters, respectively. Data are expressed as mean ± standard error. * P < 0.05 compared to 5 Fr catheter group. (JPEG 87 KB)
Additional file 3: Figure S3: Time to alleviation of fever. In patients with acute cholangitis, the period to alleviation of fever after nasobiliary catheter placement was investigated in both groups. The result is shown in the Kaplan-Meier method and the difference is analysed by the Log-rank test. (JPEG 255 KB)
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- Endoscopic nasobiliary drainage for obstructive jaundice using either a 5 Fr or 7 Fr catheter: a prospective, randomized trial
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