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Covered or Uncovered Bile Duct Stents

Primary Purpose

Bile Duct Neoplasms

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

covered or uncovered stents

About this trial

This is an interventional treatment trial for Bile Duct Neoplasms focused on measuring covered, uncovered, palliative treatment, stent

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kjell-Arne Ung, Dpt of Internal Medicine, Karnsjukhuset,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

covered self expandable metallic stents

Uncovered self expandable metallic stent

Arm Description

Patients with bile malignant bile duct strictures are randomized to covered or uncovered stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary objectives were to study difference in technical success, efficacy of drainage and complication rate between covered and uncovered metal stents

Full Information

NCT ID

NCT01232101

First Posted

November 1, 2010

Last Updated

November 1, 2010

Sponsor

Göteborg University

1. Study Identification

Unique Protocol Identification Number

NCT01232101

Brief Title

Covered or Uncovered Bile Duct Stents

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Göteborg University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bile Duct Neoplasms

Keywords

covered, uncovered, palliative treatment, stent

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

covered self expandable metallic stents

Arm Type

Active Comparator

Arm Description

Patients with bile malignant bile duct strictures are randomized to covered or uncovered stent

Arm Title

Uncovered self expandable metallic stent

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

covered or uncovered stents

Other Intervention Name(s)

ERCP, Bile duct neoplasms

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Stent occlusion or patient death

Secondary Outcome Measure Information:

Title

Secondary objectives were to study difference in technical success, efficacy of drainage and complication rate between covered and uncovered metal stents

Time Frame

Evaluated within three days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kjell-Arne Ung, PhD, MD

Organizational Affiliation

Dpt Int Med, Skovde

Official's Role

Study Director

Facility Information:

Facility Name

Kjell-Arne Ung, Dpt of Internal Medicine, Karnsjukhuset,

City

Skovde

ZIP/Postal Code

SE-54185

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Covered or Uncovered Bile Duct Stents

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