Research Article
A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Table 3
Key effectiveness results.
| Measure | Measure of success (%) | [95% CI] |
| Primary endpoint | | | Adequacy of palliation | 54 (98.2%) | [90.3%, 100%]* | Secondary endpoints | | | Stent deployment/technical success | 57 (98.3%) | [90.8%, 100%] | Number of biliary obstructive symptoms at baseline | | | Mean ± SD () | | [2.0, 3.50] | Range (Min, Max) | (1, 8) | | Median | 2 | | Number of biliary obstructive symptoms at month 6 | | | Mean ± SD () | | [0.00, 0.33] | Range (Min,Max) | (0, 2) | | Median | 0 | | Stent patency | 21 (91.3%) | [72.0%, 98.9%] | Reduction of bilirubin level at month 1 | 44 (97.8%) | [88.2%, 99.9%] |
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Intent-to-treat (58).
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