Bile Duct ObstructionPhase 4NCT01862198
The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
A Phase 4 study testing EUS-guided biliary drainage with a hybrid metallic stent in people with Bile Duct Obstruction and Disorder of Bile Duct Stent, run by Inje University at 2 sites in South Korea.
Trial summary
The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bile Duct Obstruction, Disorder of Bile Duct Stent, Neoplasms
- What is being tested?
- EUS-guided biliary drainage with a hybrid metallic stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2011to Aug 2013
- Phase
- Phase 4
- 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
- Age > 20 years
- The presence of an unresectable malignant biliary obstruction
- Failed conventional ERCP stenting
Who cannot join
- Age < 20 years
- An inability to sedate the patient due to advanced heart or pulmonary diseases
- A lack of informed consent
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Inje University Ilsan Paik Hospital
Koyang, 411-706
Asan Medical Center
Seoul, 138-736
About this study
Official title: Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.
Read the detailed description
Endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. Nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.
- Being tested
- EUS-guided biliary drainage with a hybrid metallic stent
- Medical subject headings
- Cholestasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided biliary drainage with a hybrid metallic stentDevice
EUS-guided biliary drainage with a newly designed hybrid metallic stent
| Study group | Role | What they receive |
|---|---|---|
| hybrid metallic stent | Experimental | Patients group who were inserted a hybrid metallic stent Receives: Device: EUS-guided biliary drainage with a hybrid metallic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The stent patency rate
Measured: Up to 48 weeks
Secondary outcomes (2)
Patients' survival rate
Measured: Up to 48 weeks
Complication rate related to the hybrid stents
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startSep 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct ObstructionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tea Jun Song, Inje University
- Investigators
- Sang Soo Lee, MD, PhD, Study chair, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul , South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862198
- Sponsor's protocol ID
- S2012-1819-0002
- Status last verified
- Nov 2013
- First submitted
- 19 May 2013
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
- ClinicalTrials.gov ID
- NCT01862198
- Acronym / sponsor ID
- S2012-1819-0002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 24 May 2013 (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 investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.
Detailed description
Endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. Nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hybrid metallic stent | Experimental | Device: EUS-guided biliary drainage with a hybrid metallic stentPatients group who were inserted a hybrid metallic stent |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 20 years
- The presence of an unresectable malignant biliary obstruction
- Failed conventional ERCP stenting
Key exclusion criteria (3 listed)
- Age < 20 years
- An inability to sedate the patient due to advanced heart or pulmonary diseases
- A lack of informed consent
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 |
|---|---|---|
| EUS-guided biliary drainage with a hybrid metallic stentEUS-guided biliary drainage with a newly designed hybrid metallic stent | Device | hybrid metallic stent |
Primary outcome
The stent patency rate
Time frame: Up to 48 weeks
2 secondary outcomes
Patients' survival rate
Time frame: Up to 48 weeks
Complication rate related to the hybrid stents
Time frame: Up to 48 weeks
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 2 Dec 2013.
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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.
Sang Soo Lee, MD, PhD study chair
Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul , South Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EUS-guided biliary drainage with a hybrid metallic stent in people with Bile Duct Obstruction and Disorder of Bile Duct Stent, run by Inje University at 2 sites 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 3 inclusion and 3 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 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The stent patency rate (time frame: Up to 48 weeks). 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 2 Dec 2013.