Bile Duct NeoplasmsNCT01232101
Covered or Uncovered Bile Duct Stents
A study testing covered or uncovered stents in people with Bile Duct Neoplasms, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bile Duct Neoplasms
- What is being tested?
- covered or uncovered stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Stricture close to hilus
- Need for interpreter
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Kjell-Arne Ung, Dpt of Internal Medicine, Karnsjukhuset,
Skövde, SE-54185
About this study
Official title: Covered and Uncovered Self Expandable Metallic Stents Are Equally Efficacious in Bile Duct Strictures. Results of a Randomized Study.
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 The plastic stents have been replaced by self expandable metallic stents.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
Read the detailed description
0
- Conditions
- Bile Duct Neoplasms
- Being tested
- covered or uncovered stents
- Keywords
- covered, uncovered, palliative treatment, stent
- Medical subject headings
- Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covered or uncovered stentsDevice
Also called ERCP, Bile duct neoplasms
Patients are randomized to covered or uncovered stent. Stent patency is monitored and compared as well as complications, efficacy and technical success.
| Study group | Role | What they receive |
|---|---|---|
| covered self expandable metallic stents | Active comparator | Patients with bile malignant bile duct strictures are randomized to covered or uncovered stent Receives: Device: covered or uncovered stents |
| Uncovered self expandable metallic stent | Active comparator | Not described Receives: Device: covered or uncovered stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of the present study was to compare and stent patency between covered and uncovered bileduct SEMS
Measured: 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
Measured: Evaluated within three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startMar 2007
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kjell-Arne Ung, PhD, MD, Study director, Dpt Int Med, Skovde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232101
- Sponsor's protocol ID
- CUMS-01
- Status last verified
- Apr 2025
- First submitted
- 1 Nov 2010
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covered and Uncovered Self Expandable Metallic Stents Are Equally Efficacious in Bile Duct Strictures. Results of a Randomized Study.
- ClinicalTrials.gov ID
- NCT01232101
- Acronym / sponsor ID
- CUMS-01
- Conditions
- Bile Duct Neoplasms
- Keywords
- covered, uncovered, palliative treatment, stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
0
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| covered self expandable metallic stents | Active comparator | Device: covered or uncovered stentsPatients with bile malignant bile duct strictures are randomized to covered or uncovered stent |
| Uncovered self expandable metallic stent | Active comparator | Device: covered or uncovered stents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Stricture close to hilus
- Need for interpreter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| covered or uncovered stentsAlso: ERCP, Bile duct neoplasmsPatients are randomized to covered or uncovered stent. Stent patency is monitored and compared as well as complications, efficacy and technical success. | Device | Uncovered self expandable metallic stent, covered self expandable metallic stents |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjell-Arne Ung, PhD, MD study director
Dpt Int Med, Skovde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing covered or uncovered stents in people with Bile Duct Neoplasms, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.