Obstruction of Biliary TreeNCT01875549
Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent
A study testing stent insertion and Endoscopic retrograde cholangiopancreatoscopy(ERCP) in people with Obstruction of Biliary Tree and Cholangiocarcinoma, run by Kwang Hyuck Lee.
Trial summary
Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstruction of Biliary Tree, Cholangiocarcinoma, Hepatocellular Carcinoma
- What is being tested?
- stent insertion and Endoscopic retrograde cholangiopancreatoscopy(ERCP)
- 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
- No sites listed yet
- Study dates
- May 2013to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18
- diagnosis of malignancy in pathology or cytology
- jaundice(Total bilirubin)> 2.0 mg/dL
- Diagnosed malignant hilar invasion to CT or other image finding
Who cannot join
- bleeding tendency(INR>1.5)
- Pregnancy
- severe liver,kidney disease
About this study
Official title: Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent
Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.
Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents.
Read more
There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent.
Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent
- Conditions
- Obstruction of Biliary Tree, Cholangiocarcinoma, Hepatocellular Carcinoma, Malignant Lymphadenopathy, Gall Bladder Cancer
- Being tested
- stent insertion, Endoscopic retrograde cholangiopancreatoscopy(ERCP)
- Medical subject headings
- Cholangiocarcinoma, Carcinoma, Hepatocellular, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stent insertionDevice
Also called Niti-S large cell D-type biliary stent [LCD]
to use a LCD stent at an unilateral or bilateral stent insertion
Endoscopic retrograde cholangiopancreatoscopy(ERCP)Procedure or surgery
to use ERCP for a stent insertion in an obstructive biliary tract
| Study group | Role | What they receive |
|---|---|---|
| Unilateral stent insertion group | Active comparator | the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP) Receives: Device: stent insertion; Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP) |
| Bilateral stent insertion group | Active comparator | the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP) Receives: Device: stent insertion; Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent patency
Participants will followed for the new obstruction(new jaundice) will occur.
Measured: up to 1year
Secondary outcomes (1)
survival period
Participants will followed for 1year.
Measured: up to 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2016 (estimated)
Why it stopped: no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstruction of Biliary TreeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwang Hyuck Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kwang Hyuck Lee, Samsung Medical Center
- Investigators
- Kwang hyuck Lee, PhD, Study director, Division of Gastroenterology,Department of internal medicaion,samsung medical center,Sungkyunkwan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875549
- Sponsor's protocol ID
- 2013-03-014-002
- Status last verified
- Apr 2016
- First submitted
- 4 Jun 2013
- 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 Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent
- ClinicalTrials.gov ID
- NCT01875549
- Acronym / sponsor ID
- 2013-03-014-002
- Conditions
- Obstruction of Biliary Tree, Cholangiocarcinoma, Hepatocellular Carcinoma, Malignant Lymphadenopathy, Gall Bladder Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kwang Hyuck LeeUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 12 Jun 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.
Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.
Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents.
There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent.
Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral stent insertion group | Active comparator | Device: stent insertion, Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP) |
| Bilateral stent insertion group | Active comparator | Device: stent insertion, Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age> 18
- diagnosis of malignancy in pathology or cytology
- jaundice(Total bilirubin)> 2.0 mg/dL
- Diagnosed malignant hilar invasion to CT or other image finding
Key exclusion criteria (3 listed)
- bleeding tendency(INR>1.5)
- Pregnancy
- severe liver,kidney disease
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 |
|---|---|---|
| stent insertionAlso: Niti-S large cell D-type biliary stent [LCD]to use a LCD stent at an unilateral or bilateral stent insertion | Device | Bilateral stent insertion group, Unilateral stent insertion group |
| Endoscopic retrograde cholangiopancreatoscopy(ERCP)to use ERCP for a stent insertion in an obstructive biliary tract | Procedure or surgery | Bilateral stent insertion group, Unilateral stent insertion group |
Primary outcome
Stent patency
Time frame: up to 1year
Participants will followed for the new obstruction(new jaundice) will occur.
1 secondary outcome
survival period
Time frame: up to 1year
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, PhD study director
Division of Gastroenterology,Department of internal medicaion,samsung medical center,Sungkyunkwan University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing stent insertion and Endoscopic retrograde cholangiopancreatoscopy(ERCP) in people with Obstruction of Biliary Tree and Cholangiocarcinoma, run by Kwang Hyuck Lee.
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 4 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: 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.
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?
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?
Stent patency (time frame: up to 1year). 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.