Malignant Biliary ObstructionNCT05220475
A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent
A study testing fully covered self-expandable metal stent with an anchoring external plastic stent and uncovered self-expandable metal stent in people with Malignant Biliary Obstruction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- fully covered self-expandable metal stent with an anchoring external plastic stent and uncovered self-expandable metal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Oct 2021to 24 Oct 2024
- 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
- Adults with 19 years of age or older
- Those who voluntarily consented to the trial and signed a written consent
- Inoperable malignant biliary obstruction
Who cannot join
- Previous surgical biliary drainage
- Patients continuosly requiring percutaneous transhepatic biliary drainage
- History of biliary drainage with metal stent
- Biliary obstruction located in hilum or intrahepatic duct
- Patients with life expectancy of 3 months or less
- On pregnancy
- Unable to underwent endoscopic procedures
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Sang Hyub Lee, MD, PhD
About this study
Official title: A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent: Prospective Randomized Multicenter Study
Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction
Read the detailed description
This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.
- Conditions
- Malignant Biliary Obstruction
- Being tested
- fully covered self-expandable metal stent with an anchoring external plastic stent, uncovered self-expandable metal stent
- Keywords
- Fully Covered Self Expandable Metal Stent, Uncovered Self Expandable Metal Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fully covered self-expandable metal stent with an anchoring external plastic stentDevice
Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent
uncovered self-expandable metal stentDevice
Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent
| Study group | Role | What they receive |
|---|---|---|
| fc-SEMS with anchoring plastic stent | Experimental | fully covered self-expanable metal stent with an external anchoring plastic stent Receives: Device: fully covered self-expandable metal stent with an anchoring external plastic stent |
| uc-SEMS | Active comparator | uncovered self-expandable metal stent Receives: Device: uncovered self-expandable metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patent stent
The number of patient without stent dysfuction divided by total number of patients
Measured: 1 year
Secondary outcomes (5)
Stent obstruction
Suspected by jaundice (Total bilirubin > 2 upper normal limit) or radiologic finding of stent occlusion which is confirmed by ERCP
Measured: 1 year
Stent migration
Radiologic finding of migration through Abdomen X-ray or CT scan
Measured: 1 year
Re-intervention
Endoscopic retrograde biliary drainage or Percutaneous transhepatic biliary drainage
Measured: 1 year
Adverse event
acute cholangitis, acute cholecystitis, acute pancreatitis
Measured: 1 year
Overall survival
Timespan from the diagnosis to the death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start25 Oct 2021
- Primary completion24 Oct 2023 (estimated)
- Study completion24 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Hyub Lee, Seoul National University Hospital
- Investigators
- Sang Hyub Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220475
- Sponsor's protocol ID
- H-2012-043-1179
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 2 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent: Prospective Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT05220475
- Acronym / sponsor ID
- H-2012-043-1179
- Conditions
- Malignant Biliary Obstruction
- Keywords
- Fully Covered Self Expandable Metal Stent, Uncovered Self Expandable Metal Stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 24 Oct 2023 (estimated)
- Study completion
- 24 Oct 2024 (estimated)
- First posted
- 2 Feb 2022 (actual)
- 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.
Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction
Detailed description
This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fc-SEMS with anchoring plastic stent | Experimental | Device: fully covered self-expandable metal stent with an anchoring external plastic stentfully covered self-expanable metal stent with an external anchoring plastic stent |
| uc-SEMS | Active comparator | Device: uncovered self-expandable metal stentuncovered 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 (3 listed)
- Adults with 19 years of age or older
- Those who voluntarily consented to the trial and signed a written consent
- Inoperable malignant biliary obstruction
Key exclusion criteria (7 listed)
- Previous surgical biliary drainage
- Patients continuosly requiring percutaneous transhepatic biliary drainage
- History of biliary drainage with metal stent
- Biliary obstruction located in hilum or intrahepatic duct
- Patients with life expectancy of 3 months or less
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 |
|---|---|---|
| fully covered self-expandable metal stent with an anchoring external plastic stentExtrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent | Device | fc-SEMS with anchoring plastic stent |
| uncovered self-expandable metal stentExtrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent | Device | uc-SEMS |
Primary outcome
Rate of patent stent
Time frame: 1 year
The number of patient without stent dysfuction divided by total number of patients
5 secondary outcomes
Stent obstruction
Time frame: 1 year
Stent migration
Time frame: 1 year
Re-intervention
Time frame: 1 year
Adverse event
Time frame: 1 year
Overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
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Active, not recruiting
Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents
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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 Hyub Lee, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fully covered self-expandable metal stent with an anchoring external plastic stent and uncovered self-expandable metal stent in people with Malignant Biliary Obstruction, run by Seoul National University Hospital 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 3 inclusion and 7 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 2 Feb 2022. 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 Sang Hyub Lee, MD, PhD (82-2072-2228, gidoctor@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patent stent (time frame: 1 year). 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 Feb 2022.