CompletedPhase 4

Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

South Korea43 participantsStarted 2010-06

Plain-language summary

Endoscopic retrograde biliary drainage (ERBD) is now widely accepted as the standard intervention for the relief of obstructive jaundice in patients with unresectable malignant biliary obstruction. Although plastic stents (PSs) were developed earlier, self-expandable metal stents (SEMSs) are now used widely as the initial choice for ERBD in this setting, as SEMSs offer longer patency.However, SEMSs do become occluded in some patients. There are a limited number of reports on the management of occluded SEMS with various results. The aim of this study is to compare the efficacy of ComVi stents SEMSs with uncovered SEMS in subsequent ERBD after the occlusion of initial SEMSs.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. cholangitis (as defined by fever, tenderness in the right upper quadrant or epigastrium, and/or a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion)
✓. a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion

What they're measuring

The stent patency

Timeframe: up to 53 months

Trial details

NCT IDNCT01315522

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11

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