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Covered or Uncovered Bile Duct Stents

Covered and Uncovered Self Expandable Metallic Stents Are Equally Efficacious in Bile Duct Strictures. Results of a Randomized Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01232101
Enrollment
71
Registered
2010-11-02
Start date
2007-03-31
Completion date
2009-08-31
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Neoplasms

Keywords

covered, uncovered, palliative treatment, stent

Brief summary

The study is investigator initiated. Tumors that gives the narrowing of the bile ducts prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk of bacterial growth in bile with severe infections as a result. Unresectable bile duct strictures have routinely been treated them with plastic stents. The plastic stents have been replaced by self expandable metallic stents. These stents remain open longer for reasons that they have a larger diameter so that the bile flows through more easily. One problem with these stents, however, is that the tumor growing through the wire mesh which forms the wall of the stent. This has led to the development of so-called covered stents. Whether covered stents have longer patency is unclear as well as whether they are as safe. There is reason to believe that covered stents remain open longer, but there may be an increased risk of migration and other complications. The purpose is to prospectively and randomized compare the two stent types. The study endpoint is the clogging of the stent or the patient's death. We also monitor complications, regress time of the jaundice and success rate of stent placement

Detailed description

0

Interventions

DEVICEcovered or uncovered stents

Patients are randomized to covered or uncovered stent. Stent patency is monitored and compared as well as complications, efficacy and technical success.

Sponsors

Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with unresectable, distal bile duct stricture needing relieved endoscopically * Expected survival greater than 3 months * The patient must give written consent to participate in the study

Exclusion criteria

* Stricture close to hilus * Need for interpreter

Design outcomes

Primary

MeasureTime frame
The primary aim of the present study was to compare and stent patency between covered and uncovered bileduct SEMSStent occlusion or patient death

Secondary

MeasureTime frame
Secondary objectives were to study difference in technical success, efficacy of drainage and complication rate between covered and uncovered metal stentsEvaluated within three days

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026