Bile Duct NeoplasmPhase 3NCT01622803
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
A Phase 3 study testing parallel stent and Y-stent (BONASTENT M-Hilar) in people with Bile Duct Neoplasm and Obstructive Jaundice, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis. Bilateral drainage is more physiologic and have more long patency than unilateral drainage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Neoplasm, Obstructive Jaundice
- What is being tested?
- parallel stent and Y-stent (BONASTENT M-Hilar)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Aug 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy
Who cannot join
- patients with endoscopic retrograde cholangiogram is not possible
- bleeding tendency (PT INR > 1.5, platelet < 50,000)
- poor general condition (ECOG 3-4) or cardiopulmonary deterioration
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.
Bilateral drainage is more physiologic and have more long patency than unilateral drainage.
There are two methods of bilateral drainage: Y-stent and side by side.
However there are no clinical data about comparing the effectiveness of these two methods.
Therefore the investigators want to compare the clinical outcomes of two methods:
Y-stent and side by side.
- Conditions
- Bile Duct Neoplasm, Obstructive Jaundice
- Being tested
- parallel stent, Y-stent (BONASTENT M-Hilar)
- Medical subject headings
- Bile Duct Neoplasms, Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parallel stentProcedure or surgery
Also called bilateral pig tail plastic stent
bilateral parallel stent insertion (right and left side)
Y-stent (BONASTENT M-Hilar)Device
Also called BONASTENT M-Hilar, Standard Sci Tech Inc, Seoul, South Korea
Bilateral Y-stent insertion (stent in stent type)
| Study group | Role | What they receive |
|---|---|---|
| parallel stent | Active comparator | parallel stent insertion group Receives: Procedure: parallel stent |
| Y-stent | Active comparator | Y-stent insertion group Receives: Device: Y-stent (BONASTENT M-Hilar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time taken to insert bilateral stent
Measured: After the ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Why it stopped: Patients enrollment problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct NeoplasmStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwang Hyuck Lee, Samsung Medical Center
- Investigators
- Kwang hyuck Lee, MD, phD, Study director, Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622803
- Sponsor's protocol ID
- KH0LEE
- Status last verified
- Apr 2016
- First submitted
- 12 Jun 2012
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
- ClinicalTrials.gov ID
- NCT01622803
- Acronym / sponsor ID
- KH0LEE
- Conditions
- Bile Duct Neoplasm, Obstructive Jaundice
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patients enrollment problem
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 19 Jun 2012 (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.
Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.
Bilateral drainage is more physiologic and have more long patency than unilateral drainage.
There are two methods of bilateral drainage: Y-stent and side by side.
However there are no clinical data about comparing the effectiveness of these two methods.
Therefore the investigators want to compare the clinical outcomes of two methods:
Y-stent and side by side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parallel stent | Active comparator | Procedure: parallel stentparallel stent insertion group |
| Y-stent | Active comparator | Device: Y-stent (BONASTENT M-Hilar)Y-stent insertion group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18 years
- patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy
Key exclusion criteria (4 listed)
- patients with endoscopic retrograde cholangiogram is not possible
- bleeding tendency (PT INR > 1.5, platelet < 50,000)
- poor general condition (ECOG 3-4) or cardiopulmonary deterioration
- pregnancy
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 |
|---|---|---|
| parallel stentAlso: bilateral pig tail plastic stentbilateral parallel stent insertion (right and left side) | Procedure or surgery | parallel stent |
| Y-stent (BONASTENT M-Hilar)Also: BONASTENT M-Hilar, Standard Sci Tech Inc, Seoul, South KoreaBilateral Y-stent insertion (stent in stent type) | Device | Y-stent |
Primary outcome
The time taken to insert bilateral stent
Time frame: After the ERCP procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
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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.
Kwang hyuck Lee, MD, phD study director
Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
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 parallel stent and Y-stent (BONASTENT M-Hilar) in people with Bile Duct Neoplasm and Obstructive Jaundice, 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 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: withdrawn, as of the sponsor's last update on 26 Apr 2016. 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 was withdrawn before enrolling participants, so there are no results.
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 time taken to insert bilateral stent (time frame: After the ERCP procedure). 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 26 Apr 2016.