Malignant Distal Biliary StrictureNCT02178618
Partially Covered and Uncovered Metal Stent for Malignant Distal Biliary Stricture
A study testing Deployment of Partially covered biliary self expandable metal stent and Deployment of uncovered biliary self expandable metal stent in people with Malignant Distal Biliary Stricture, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Endoscopic retrograde biliary drainage with a self-expandable metal stent (SEMS) has been used as a principle palliative method of distal biliary obstruction in patients with pancreaticobiliary cancers. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Malignant Distal Biliary Stricture
- What is being tested?
- Deployment of Partially covered biliary self expandable metal stent and Deployment of uncovered biliary self expandable metal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento Jan 2006
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 20 years
- malignant biliary obstruction, 2 cm distal to hilum
- unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal
- expected survival > 4 months based on Karnofsky performance score.
Who cannot join
- history of biliary surgery except cholecystectomy
- history of SEMS placement
- coagulopathy (INR>1.5, Platelet<50000)
- duodenal stricture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Partially Covered Versus Uncovered Self Expandable Metal Stents for the Palliation of Malignant Distal Biliary Stricture
Endoscopic retrograde biliary drainage with a self-expandable metal stent (SEMS) has been used as a principle palliative method of distal biliary obstruction in patients with pancreaticobiliary cancers. With potentially curative surgical resection being impossible, the maintenance of successful biliary drainage through patent stent has been regarded as the key to improve the quality of life and survival of patient, because it could prevent biliary infection or liver failure, and give patients opportunities for anti-cancer chemotherapy and/or radiotherapy.
Although SEMSs have been reported to be superior to large bore plastic stents in terms of stent patency, they still have some controversial issues to resolve in relation to stent dysfunction and adverse event. It has been widely accepted that covered SEMSs designed to overcome the stent failure of uncovered SEMSs related to tumor ingrowth, have significant higher rate of stent migration as well as tumor overgrowth. Therefore covered SEMSs did not show the clear clinical excellence in the cumulative stent patency over uncovered SEMSs, despite some clinical results of randomized trials favor to covered SEMSs.
Read more
From the perspective of adverse events such as pancreatitis and cholecystitis, conflicting results have been produced. It was initially assumed that covered SEMSs could cause the higher incidence of pancreatitis and cholecystitis attributed to occlusion of pancreatic duct and cystic duct by covering materials. However, no significant difference was found with regard to the incidence of pancreatitis and cholecystitis between covered and uncovered SEMSs in several randomized trials and meta-analysis.
The aim of the current study is to compare the cumulative stent patency of partially covered and uncovered SEMS as a primary objective, and investigate overall patient survival, stent dysfunction-free patient survival, and incidence of adverse events including stent dysfunction as secondary objectives.
- Conditions
- Malignant Distal Biliary Stricture
- Being tested
- Deployment of Partially covered biliary self expandable metal stent, Deployment of uncovered biliary self expandable metal stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deployment of Partially covered biliary self expandable metal stentDevice
Deployment of uncovered biliary self expandable metal stentDevice
| Study group | Role | What they receive |
|---|---|---|
| Partially covered biliary self expandable metal stent | Active comparator | Not described Receives: Device: Deployment of Partially covered biliary self expandable metal stent |
| Uncovered biliary self expandable metal stent | Active comparator | Not described Receives: Device: Deployment of uncovered biliary self expandable metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative stent patency
Measured: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months
Secondary outcomes (2)
Overall patient survival
Measured: From the date of randomization until the date of death from any cause, assessed upto 12 months
Stent dysfunction free-patient survival
Measured: From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Distal Biliary StrictureStudies 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
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Hong Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178618
- Sponsor's protocol ID
- AJIRB-DEV-DE3-14-001
- Status last verified
- Jun 2014
- First submitted
- 25 Jun 2014
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Partially Covered Versus Uncovered Self Expandable Metal Stents for the Palliation of Malignant Distal Biliary Stricture
- ClinicalTrials.gov ID
- NCT02178618
- Acronym / sponsor ID
- AJIRB-DEV-DE3-14-001
- Conditions
- Malignant Distal Biliary Stricture
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Primary completion
- Jan 2006 (actual)
- First posted
- 1 Jul 2014 (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.
Endoscopic retrograde biliary drainage with a self-expandable metal stent (SEMS) has been used as a principle palliative method of distal biliary obstruction in patients with pancreaticobiliary cancers. With potentially curative surgical resection being impossible, the maintenance of successful biliary drainage through patent stent has been regarded as the key to improve the quality of life and survival of patient, because it could prevent biliary infection or liver failure, and give patients opportunities for anti-cancer chemotherapy and/or radiotherapy.
Although SEMSs have been reported to be superior to large bore plastic stents in terms of stent patency, they still have some controversial issues to resolve in relation to stent dysfunction and adverse event. It has been widely accepted that covered SEMSs designed to overcome the stent failure of uncovered SEMSs related to tumor ingrowth, have significant higher rate of stent migration as well as tumor overgrowth. Therefore covered SEMSs did not show the clear clinical excellence in the cumulative stent patency over uncovered SEMSs, despite some clinical results of randomized trials favor to covered SEMSs.
From the perspective of adverse events such as pancreatitis and cholecystitis, conflicting results have been produced. It was initially assumed that covered SEMSs could cause the higher incidence of pancreatitis and cholecystitis attributed to occlusion of pancreatic duct and cystic duct by covering materials. However, no significant difference was found with regard to the incidence of pancreatitis and cholecystitis between covered and uncovered SEMSs in several randomized trials and meta-analysis.
The aim of the current study is to compare the cumulative stent patency of partially covered and uncovered SEMS as a primary objective, and investigate overall patient survival, stent dysfunction-free patient survival, and incidence of adverse events including stent dysfunction as secondary objectives.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partially covered biliary self expandable metal stent | Active comparator | Device: Deployment of Partially covered biliary self expandable metal stent |
| Uncovered biliary self expandable metal stent | Active comparator | Device: Deployment of uncovered biliary self expandable metal stent |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 20 years
- malignant biliary obstruction, 2 cm distal to hilum
- unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal
- expected survival > 4 months based on Karnofsky performance score.
Key exclusion criteria (4 listed)
- history of biliary surgery except cholecystectomy
- history of SEMS placement
- coagulopathy (INR>1.5, Platelet<50000)
- duodenal stricture
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 |
|---|---|---|
| Deployment of Partially covered biliary self expandable metal stent | Device | Partially covered biliary self expandable metal stent |
| Deployment of uncovered biliary self expandable metal stent | Device | Uncovered biliary self expandable metal stent |
Primary outcome
Cumulative stent patency
Time frame: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months
2 secondary outcomes
Overall patient survival
Time frame: From the date of randomization until the date of death from any cause, assessed upto 12 months
Stent dysfunction free-patient survival
Time frame: From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 12 months
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 1 Jul 2014.
Related trials for Malignant Distal Biliary Stricture
Recruiting
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
Malignant Biliary Obstruction, Malignant Biliary Stricture
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deployment of Partially covered biliary self expandable metal stent and Deployment of uncovered biliary self expandable metal stent in people with Malignant Distal Biliary Stricture, run by Ajou University School of Medicine at 1 site in South Korea.
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 4 inclusion and 4 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 1 Jul 2014. 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 South Korea. 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?
Cumulative stent patency (time frame: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months). 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 1 Jul 2014.