Bile Duct DiseasePhase 3NCT00945516
Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
A Phase 3 study testing Bona stent® (Flared end FCSEMS) and Hanarostent® (Anchoring FCSEMS) in people with Bile Duct Disease, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring FCSEMS for benign biliary stricture. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bile Duct Disease
- What is being tested?
- Bona stent® (Flared end FCSEMS) and Hanarostent® (Anchoring FCSEMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to May 2010
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- Patient with benign bile duct stricture
Who cannot join
- No written informed consent
- Malignant biliary obstruction
- Patients with uncorrectable severe coagulopathy
- Patients with severe cardiopulmonary disease precluding sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study
The purpose of this study is to determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring FCSEMS for benign biliary stricture.
Read the detailed description
Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. Fully covered self-expanding metal stent(FCSEMS) placement was reported as a useful method for BBS. However, stent migration was a frequent complication of CSEMS placement. Recently, flared end FCSEMS was developed to decrease stent migration, and anchoring CSEMS was newly developed.
- Conditions
- Bile Duct Disease
- Being tested
- Bona stent® (Flared end FCSEMS), Hanarostent® (Anchoring FCSEMS)
- Keywords
- Metal stent, Bile duct stricture, Stent migration, Feasibility, Safety, Removability
- Medical subject headings
- Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bona stent® (Flared end FCSEMS)Device
Also called Bona stent® (Sewoon medical Co., LTD., Seoul, Korea)
Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.
Hanarostent® (Anchoring FCSEMS)Device
Also called Hanarostent® (M.I.Tech, Seoul, Korea)
Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.
| Study group | Role | What they receive |
|---|---|---|
| Flared end FCSEMS | Active comparator | Flared end FCSEMS will be inserted for the benign bile duct stricture. Receives: Device: Bona stent® (Flared end FCSEMS) |
| Anchoring FCSEMS | Active comparator | Anchoring FCSEMS will be inserted for benign bile duct stricture Receives: Device: Hanarostent® (Anchoring FCSEMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent migration rate
Measured: one year
Secondary outcomes (3)
Feasibility (Technical success rate and functional success rate)
Measured: one year
Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure)
Measured: one year
Removability
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bile Duct DiseaseStudies of the same condition, open and under way.
- More trials run by Asan 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Do Hyun Park, MD, PhD, Study director, Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945516
- Sponsor's protocol ID
- 2009-0233
- Status last verified
- Oct 2010
- First submitted
- 20 Jul 2009
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park DH, Lee SS, Lee TH, Ryu CH, Kim HJ, Seo DW, Park SH, Lee SK, Kim MH, Kim SJ. Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective, comparative pilot study (with videos). Gastrointest Endosc. 2011 Jan;73(1):64-70. doi: 10.1016/j.gie.2010.09.039.
PubMed 21184871
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00945516
- Acronym / sponsor ID
- 2009-0233
- Conditions
- Bile Duct Disease
- Keywords
- Metal stent, Bile duct stricture, Stent migration, Feasibility, Safety, Removability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 Jul 2009 (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 determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring FCSEMS for benign biliary stricture.
Detailed description
Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. Fully covered self-expanding metal stent(FCSEMS) placement was reported as a useful method for BBS. However, stent migration was a frequent complication of CSEMS placement. Recently, flared end FCSEMS was developed to decrease stent migration, and anchoring CSEMS was newly developed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flared end FCSEMS | Active comparator | Device: Bona stent® (Flared end FCSEMS)Flared end FCSEMS will be inserted for the benign bile duct stricture. |
| Anchoring FCSEMS | Active comparator | Device: Hanarostent® (Anchoring FCSEMS)Anchoring FCSEMS will be inserted for benign bile duct stricture |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient over 18 years old
- Patient with benign bile duct stricture
Key exclusion criteria (4 listed)
- No written informed consent
- Malignant biliary obstruction
- Patients with uncorrectable severe coagulopathy
- Patients with severe cardiopulmonary disease precluding sedation
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 |
|---|---|---|
| Bona stent® (Flared end FCSEMS)Also: Bona stent® (Sewoon medical Co., LTD., Seoul, Korea)Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP. | Device | Flared end FCSEMS |
| Hanarostent® (Anchoring FCSEMS)Also: Hanarostent® (M.I.Tech, Seoul, Korea)Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP. | Device | Anchoring FCSEMS |
Primary outcome
Stent migration rate
Time frame: one year
3 secondary outcomes
Feasibility (Technical success rate and functional success rate)
Time frame: one year
Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure)
Time frame: one year
Removability
Time frame: one year
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 19 Oct 2010.
- Derived from this study: PubMed 21184871Park DH, Lee SS, Lee TH, Ryu CH, Kim HJ, Seo DW, Park SH, Lee SK, Kim MH, Kim SJ. Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective, comparative pilot study (with videos). Gastrointest Endosc. 2011 Jan;73(1):64-70. doi: 10.1016/j.gie.2010.09.039.
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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.
Do Hyun Park, MD, PhD study director
Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bona stent® (Flared end FCSEMS) and Hanarostent® (Anchoring FCSEMS) in people with Bile Duct Disease, run by Asan 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 2 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 19 Oct 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Stent migration rate (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00945516, which also lists 1 linked publication.
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 19 Oct 2010.