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


N/A
N/A
N/A
Not Enrolling
Both
Bile Duct Neoplasms

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Trial Information

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


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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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The primary aim of the present study was to compare and stent patency between covered and uncovered bileduct SEMS

Outcome Time Frame:

Stent occlusion or patient death

Safety Issue:

Yes

Principal Investigator

Kjell-Arne Ung, PhD, MD

Investigator Role:

Study Director

Investigator Affiliation:

Dpt Int Med, Skovde

Authority:

Sweden: Regional Ethical Review Board

Study ID:

CUMS-01

NCT ID:

NCT01232101

Start Date:

March 2007

Completion Date:

August 2009

Related Keywords:

  • Bile Duct Neoplasms
  • covered, uncovered, palliative treatment, stent
  • Bile Duct Neoplasms
  • Neoplasms

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