Covered or Uncovered Bile Duct Stents

Bile Duct Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232101
• Other study ID #: CUMS-01
• Status: Completed
• Phase: N/A
• First received: November 1, 2010
• Last updated: November 1, 2010
• Start date: March 2007
• Est. completion date: August 2009

Study information

• Verified date: March 2007
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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 The plastic stents have been replaced by self expandable metallic stents.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

Description:

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bile Duct Neoplasms

Intervention

Device:
• covered 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.

Locations

Country	Name	City	State
Sweden	Kjell-Arne Ung, Dpt of Internal Medicine, Karnsjukhuset,	Skovde

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary aim of the present study was to compare and stent patency between covered and uncovered bileduct SEMS		Stent occlusion or patient death	Yes
Secondary	Secondary objectives were to study difference in technical success, efficacy of drainage and complication rate between covered and uncovered metal stents		Evaluated within three days	Yes