Covered or Uncovered Bile Duct Stents

NCT01232101 | Completed DMC

• 1 other identifier: CUMS-01
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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 The plastic stents have been replaced by self expandable metallic stents.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

Conditions

Bile Duct Neoplasms

Keywords

covered, uncovered, palliative treatment, stent

Outcome Measures

Primary Outcomes (1)

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

  Stent occlusion or patient death

Secondary Outcomes (1)

• 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

Study Arms (2)

covered self expandable metallic stents

ACTIVE COMPARATOR

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

Device: covered or uncovered stents

Uncovered self expandable metallic stent

ACTIVE COMPARATOR

Device: covered or uncovered stents

Interventions

covered or uncovered stents DEVICE

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

Also known as: ERCP, Bile duct neoplasms

Uncovered self expandable metallic stent; covered self expandable metallic stents

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Stricture close to hilus
• Need for interpreter

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

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

Skövde, SE-54185, Sweden

Location

MeSH Terms

Conditions

Bile Duct Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Kjell-Arne Ung, PhD, MD

  Dpt Int Med, Skovde

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 2, 2010
• Study Start: March 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

SE (1)