Klatskin TumorNCT02166970
Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction
A study testing Metallic stent deployment in hilar obstruction in people with Klatskin Tumor, run by Soon Chun Hyang University at 1 site in South Korea.
Trial summary
In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Klatskin Tumor
- What is being tested?
- Metallic stent deployment in hilar obstruction
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2014to 30 Oct 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 years
- inoperable hilar malignancy
Who cannot join
- age under 18 years
- uncontrolled coagulopathy
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction: A Multicenter Prospective Randomized Study
In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious. The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.
Read the detailed description
In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness.
However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious.
The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.
First as an unilateral or bilateral stent will be deployed according to criteria.
In bilateral group, stent-in-stent or side-by-side deployment will be included.
- Conditions
- Klatskin Tumor
- Being tested
- Metallic stent deployment in hilar obstruction
- Keywords
- Hilar tumor, Metal stent, Single, Multiple
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metallic stent deployment in hilar obstructionDevice
Also called Single stent insertion, Multiple stent insertion using stent-in-stent method, Multiple stent insertion using side-by-side method
Single stent insertion: metal stent deployment to right or left intrahepatic duct Multiple stenting: Stent-in-stent or side-by-side deployment
| Study group | Role | What they receive |
|---|---|---|
| Single stent deployment | Experimental | Metallic stent deployment in hilar obstruction. Insertion of metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV). Receives: Device: Metallic stent deployment in hilar obstruction |
| Multiple stent deployment | Active comparator | Metallic stent deployment in hilar obstruction. Insertion of multiple metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV). Receives: Device: Metallic stent deployment in hilar obstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintervention rate when stents occluded
When the stents occluded after successful single or multiple stent deployment, the outcome measure is assessed.
Measured: 2 years
Secondary outcomes (1)
Technical success of single or multiple stents
When the bilirubin level decrease more than 50% within one week or 75% within one month.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study start1 Mar 2014
- Primary completion28 Feb 2016
- Study completion30 Oct 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 Klatskin TumorStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soon Chun Hyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Hoon Lee, Soon Chun Hyang University
- Investigators
- Tae Hoon Lee, MD, PhD, Principal investigator, Soonchunhyang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166970
- Sponsor's protocol ID
- Hilar stenting
- Status last verified
- Feb 2017
- First submitted
- 13 Jun 2014
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee TH, Kim TH, Moon JH, Lee SH, Choi HJ, Hwangbo Y, Hyun JJ, Choi JH, Jeong S, Kim JH, Park DH, Han JH, Park SH. Bilateral versus unilateral placement of metal stents for inoperable high-grade malignant hilar biliary strictures: a multicenter, prospective, randomized study (with video). Gastrointest Endosc. 2017 Nov;86(5):817-827. doi: 10.1016/j.gie.2017.04.037. Epub 2017 May 4.
PubMed 28479493
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction: A Multicenter Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02166970
- Acronym / sponsor ID
- Hilar stenting
- Conditions
- Klatskin Tumor
- Keywords
- Hilar tumor, Metal stent, Single, Multiple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Soon Chun Hyang UniversityUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 18 Jun 2014 (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.
In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious. The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.
Detailed description
In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness.
However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious.
The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.
First as an unilateral or bilateral stent will be deployed according to criteria.
In bilateral group, stent-in-stent or side-by-side deployment will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single stent deployment | Experimental | Device: Metallic stent deployment in hilar obstructionMetallic stent deployment in hilar obstruction. Insertion of metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV). |
| Multiple stent deployment | Active comparator | Device: Metallic stent deployment in hilar obstructionMetallic stent deployment in hilar obstruction. Insertion of multiple metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV). |
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
- inoperable hilar malignancy
Key exclusion criteria (3 listed)
- age under 18 years
- uncontrolled coagulopathy
- inability to provide 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 |
|---|---|---|
| Metallic stent deployment in hilar obstructionAlso: Single stent insertion, Multiple stent insertion using stent-in-stent method, Multiple stent insertion using side-by-side methodSingle stent insertion: metal stent deployment to right or left intrahepatic duct Multiple stenting: Stent-in-stent or side-by-side deployment | Device | Multiple stent deployment, Single stent deployment |
Primary outcome
Reintervention rate when stents occluded
Time frame: 2 years
When the stents occluded after successful single or multiple stent deployment, the outcome measure is assessed.
1 secondary outcome
Technical success of single or multiple stents
Time frame: 1 month
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 1 Mar 2017.
- Derived from this study: PubMed 28479493Lee TH, Kim TH, Moon JH, Lee SH, Choi HJ, Hwangbo Y, Hyun JJ, Choi JH, Jeong S, Kim JH, Park DH, Han JH, Park SH. Bilateral versus unilateral placement of metal stents for inoperable high-grade malignant hilar biliary strictures: a multicenter, prospective, randomized study (with video). Gastrointest Endosc. 2017 Nov;86(5):817-827. doi: 10.1016/j.gie.2017.04.037. Epub 2017 May 4.
- Individual participant dataSharing planned: Undecided
Related trials for Klatskin Tumor
Active, not recruitingPhase 2
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
Advanced Biliary Tract Carcinoma, Advanced Gallbladder Carcinoma
Recruiting
Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma
Perihilar Cholangiocarcinoma, Klatskin Tumor
Active, not recruitingPhase 3
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Biliary Tract Cancer
RecruitingPhase 2
Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma
Cholangiocarcinoma, Hilar Cholangiocarcinoma
Not yet recruitingObservational study
Prognostic Evaluation and Systematic Re-Assessment of Cholangiocarcinoma Therapy
Intrahepatic Cholangiocarcinoma, Perihilar Cholangiocarcinoma
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.
Tae Hoon Lee, MD, PhD principal investigator
Soonchunhyang 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 study testing Metallic stent deployment in hilar obstruction in people with Klatskin Tumor, run by Soon Chun Hyang University 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 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 1 Mar 2017. 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?
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?
Reintervention rate when stents occluded (time frame: 2 years). 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 NCT02166970, 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 1 Mar 2017; AzTrials last refreshed its copy on 2 Nov 2026.