Tumor Appearance of Biliary System ObstructionPhase 2/3NCT01421836
Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction
A Phase 2/3 study testing ERCP-guided stent insertion and EUS guided stent insertion in people with Tumor Appearance of Biliary System Obstruction, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
1. Purpose of the study -To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Appearance of Biliary System Obstruction
- What is being tested?
- ERCP-guided stent insertion and EUS guided stent insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Mar 2016
- Phase
- Phase 2/3
- 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
- distal biliary obstruction due to malignant tumor
- unresectable tumor
- Jaundice
Who cannot join
- Children
- Hilar obstruction
- Active infection
- Bleeding tendency
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, Irwon-dong, Gangnam-gu, 135-710
About this study
Official title: Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction
- Purpose of the study -To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction
- Subjects of the study -Patients who have biliary obstruction owing to malignant tumors
- Methods of the study
- Prospective randomized controlled study
- Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group
- Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction
- After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.
Read the detailed description
- Inclusion criteria 1) age: 18 - 80 2) a patients who had common bile duct dilatation because of malignant distal common bile duct obstruction in radiologically 3) Hyperbilirubinemia (total bilirubin >= 1.5 mg/dl) 4) inoperable state 5) a patients who agree to join this study
- Exclusion criteria 1) a patients who can not endure sedation 2) a patients with bleeding tendency (PT > 1.5 INR, PLT < 50,000) 3) a patients with systemic infection 4) a patients who had hilar obstruction
- Being tested
- ERCP-guided stent insertion, EUS guided stent insertion
- Keywords
- stent patency, EUS guided insertion, ERCP guided insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP-guided stent insertionProcedure or surgery
Also called ERCP-guided metal stent insertion
ERCP guided stent insertion for malignant biliary obstruction
EUS guided stent insertionProcedure or surgery
Also called EUS-guided metal stent insertion
EUS-guided stent insertion for malignant biliary obstruction
| Study group | Role | What they receive |
|---|---|---|
| ERCP guided stent insertion | Active comparator | Not described Receives: Procedure: ERCP-guided stent insertion |
| EUS guided stent insertion | Active comparator | Not described Receives: Procedure: EUS guided stent insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent patency (days)
Measured: six months
Secondary outcomes (1)
complication rate
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2015
- Study completionMar 2016
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 Tumor Appearance of Biliary System ObstructionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- Kwanghyuck 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
- NCT01421836
- Sponsor's protocol ID
- 2011-03-101-001
- Status last verified
- Apr 2016
- First submitted
- 22 Aug 2011
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 Mar 30.
PubMed 29605722
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction
- ClinicalTrials.gov ID
- NCT01421836
- Acronym / sponsor ID
- 2011-03-101-001
- Keywords
- stent patency, EUS guided insertion, ERCP guided insertion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Aug 2011 (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.
- Purpose of the study -To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction
- Subjects of the study -Patients who have biliary obstruction owing to malignant tumors
- Methods of the study
- Prospective randomized controlled study
- Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group
- Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction
- After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.
Detailed description
- Inclusion criteria 1) age: 18 - 80 2) a patients who had common bile duct dilatation because of malignant distal common bile duct obstruction in radiologically 3) Hyperbilirubinemia (total bilirubin >= 1.5 mg/dl) 4) inoperable state 5) a patients who agree to join this study
- Exclusion criteria 1) a patients who can not endure sedation 2) a patients with bleeding tendency (PT > 1.5 INR, PLT < 50,000) 3) a patients with systemic infection 4) a patients who had hilar obstruction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP guided stent insertion | Active comparator | Procedure: ERCP-guided stent insertion |
| EUS guided stent insertion | Active comparator | Procedure: EUS guided stent insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- distal biliary obstruction due to malignant tumor
- unresectable tumor
- Jaundice
Key exclusion criteria (4 listed)
- Children
- Hilar obstruction
- Active infection
- Bleeding tendency
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 |
|---|---|---|
| ERCP-guided stent insertionAlso: ERCP-guided metal stent insertionERCP guided stent insertion for malignant biliary obstruction | Procedure or surgery | ERCP guided stent insertion |
| EUS guided stent insertionAlso: EUS-guided metal stent insertionEUS-guided stent insertion for malignant biliary obstruction | Procedure or surgery | EUS guided stent insertion |
Primary outcome
stent patency (days)
Time frame: six months
1 secondary outcome
complication rate
Time frame: six months
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 28 Apr 2016.
- Derived from this study: PubMed 29605722Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 Mar 30.
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.
Kwanghyuck 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 2/3 study testing ERCP-guided stent insertion and EUS guided stent insertion in people with Tumor Appearance of Biliary System Obstruction, 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 3 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 28 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 patency (days) (time frame: six months). 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 NCT01421836, 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 28 Apr 2016; AzTrials last refreshed its copy on 27 Oct 2026.