Covered or Uncovered Bile Duct Stents

Göteborg University

Status: Completed

Conditions: Bile Duct Neoplasms

Treatments: Device: covered or uncovered stents

Study type: Interventional

Funder types: Other

Identifiers

NCT01232101

CUMS-01

Details and patient eligibility

About

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 The plastic stents have been replaced by self expandable metallic stents.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

Full description

0

Enrollment: 71 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups

covered self expandable metallic stents

Active Comparator group

Description:

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

Treatment:

Device: covered or uncovered stents

Uncovered self expandable metallic stent

Active Comparator group

Treatment:

Device: covered or uncovered stents