Biliary Tract NeoplasmsNCT02255669
Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction
A study testing partially covered SEMS and fully covered SEMS in people with Biliary Tract Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Biliary Tract Neoplasms
- What is being tested?
- partially covered SEMS and fully covered SEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Oct 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal
Who cannot join
- 1.history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR>1.5, Platelet<50000) 4.expected survival > 3 months based on Karnofsky performance score 5.duodenal stricture
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Cencer
Seoul, 135-710
Jong-Kyun Lee, M.D., Ph.D., 81-2-3410-3409, jongk.lee@samsung.com
About this study
Official title: Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction
The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.
Read the detailed description
Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration.
The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.
- Conditions
- Biliary Tract Neoplasms
- Being tested
- partially covered SEMS, fully covered SEMS
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partially covered SEMSDevice
Also called Insertion of partially covered SEMS (PCSEMS)
Used for palliation of inoperable malignant distal bile duct obstruction.
fully covered SEMSDevice
Also called Insertion of fully covered SEMS (FCSEMS)
Used for palliation of inoperable malignant distal bile duct obstruction.
| Study group | Role | What they receive |
|---|---|---|
| partially covered SEMS | Active comparator | Deployment of Partially covered biliary self expandable metal stent Receives: Device: partially covered SEMS |
| fully covered SEMS | Active comparator | Deployment of Fully covered biliary self expandable metal stent Receives: Device: fully covered SEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of stent patency
Measured: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months
Secondary outcomes (3)
overall survival
Measured: From the date of randomization until the date of death from any cause, assessed upto 12 months
stent occlusion rate
Measured: From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months
stent related complication
Measured: From the date of randomization until the date of first documented stent related complication, 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 posted2 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract NeoplasmsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Kyun Lee, M.D., Ph.D., Principal investigator, Samsung Medical Cencer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255669
- Sponsor's protocol ID
- 2014-07-187-001
- Status last verified
- Sep 2014
- First submitted
- 30 Sep 2014
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction
- ClinicalTrials.gov ID
- NCT02255669
- Acronym / sponsor ID
- 2014-07-187-001
- Conditions
- Biliary Tract Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 2 Oct 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.
The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.
Detailed description
Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration.
The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| partially covered SEMS | Active comparator | Device: partially covered SEMSDeployment of Partially covered biliary self expandable metal stent |
| fully covered SEMS | Active comparator | Device: fully covered SEMSDeployment of Fully covered biliary self expandable metal stent |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal
Key exclusion criteria (1 listed)
- 1.history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR>1.5, Platelet<50000) 4.expected survival > 3 months based on Karnofsky performance score 5.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 |
|---|---|---|
| partially covered SEMSAlso: Insertion of partially covered SEMS (PCSEMS)Used for palliation of inoperable malignant distal bile duct obstruction. | Device | partially covered SEMS |
| fully covered SEMSAlso: Insertion of fully covered SEMS (FCSEMS)Used for palliation of inoperable malignant distal bile duct obstruction. | Device | fully covered SEMS |
Primary outcome
duration of stent patency
Time frame: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months
3 secondary outcomes
overall survival
Time frame: From the date of randomization until the date of death from any cause, assessed upto 12 months
stent occlusion rate
Time frame: From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months
stent related complication
Time frame: From the date of randomization until the date of first documented stent related complication, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
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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.
Jong Kyun Lee, M.D., Ph.D. principal investigator
Samsung Medical Cencer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partially covered SEMS and fully covered SEMS in people with Biliary Tract Neoplasms, run by Samsung Medical Center 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Feb 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong Kyun Lee, M.D., Ph.D. (82-2-3410-3409, leejk@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of 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 12 Feb 2015.