Clinical Trial: Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Re-intervention for Occluded Biliary Metal Stent in Malignant Distal Bile Duct Obstruction: a Prospective Randomized Multi-center Trial Comparing Covered and Uncovered Metal Stent

Brief 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.

Detailed Summary: Endoscopic placement of self-expandable metallic stents (SEMSs) is the mainstay of palliative measures for alleviating obstructive jaundice secondary to advanced cholangiocarcinoma. Previous meta-analysis showed no significant difference in stent patency between covered and uncovered SEMS, which are currently available. However, information on secondary SEMS insertion is still scarce, and there has been no prospective trial comparing efficacy of secondary stenting between covered and uncovered SEMS for the management of occluded metal stent in malignant biliary obstruction. Previously, only two small retrospective studies addressed this issue. Given the absence of prospective trial on re-intervention for occluded SEMS in malignant biliary obstruction, we aimed to prospectively compare the efficacies and complication rates of secondary ComVi stent (cSEMS) and uSEMS for the management of such condition.
Sponsor: Seoul National University Hospital

Current Primary Outcome: The stent patency [ Time Frame: up to 53 months ]

period between stent insertion and stent occlusion or death of the patient


Original Primary Outcome: Time to stent occlusion [ Time Frame: Upon SEMS occlusion, patient death, or end of the study period (average 1 year) ]

Current Secondary Outcome:

  • Technical success [ Time Frame: for the duration of ERCP procedure, an expected average of 30 minutes ]
    Technical success was achieved when the SEMS was placed across the stricture with appropriate radiographic positioning and immediate biliary decompression
  • clinical success [ Time Frame: within 2 weeks since initial ERBD ]
    Clinical success was achieved in the case of ≥ 50% reduction or normalization of total bilirubin level (≤ 1.2 mg/dL)
  • time-to-stent occlusion [ Time Frame: up to 53 months ]
  • patient survival [ Time Frame: up to 53 months ]
  • adverse events [ Time Frame: within 4 weeks since initial ERBD ]
    stent migration, bleeding, pancreatitis, cholecystitis, or cholangitis


Original Secondary Outcome:

Information By: Seoul National University Hospital

Dates:
Date Received: June 1, 2010
Date Started: June 2010
Date Completion:
Last Updated: April 20, 2015
Last Verified: April 2015