Malignant Distal Biliary ObstructionPCSEMS-12NCT07559968
12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction
A study testing 12-mm partially covered self-expandable metallic stent and 12-mm bare self-expandable metallic stent in people with Malignant Distal Biliary Obstruction and Malignant Biliary Obstruction, run by Chung-Ang University Hospital at 1 site in South Korea.
Trial summary
Metallic stents are commonly used for biliary drainage in patients with unresectable malignant distal biliary obstruction. However, it is unclear whether a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent provides better effectiveness and safety. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Malignant Distal Biliary Obstruction, Malignant Biliary Obstruction, Biliary Obstruction
- What is being tested?
- 12-mm partially covered self-expandable metallic stent and 12-mm bare self-expandable metallic stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 May 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients who voluntarily provide written informed consent after receiving sufficient explanation of the study purpose, methods, and potential benefits and risks
- Adults aged 19 years or older
- Patients diagnosed with unresectable malignant distal biliary obstruction based on imaging studies (CT, MRI, ERCP, etc.) or histologic confirmation
- Patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) according to the institutional clinical protocol and are scheduled for metallic stent placement through the existing PTBD tract
Who cannot join
- Patients with a previous history of biliary metallic stent placement
- Patients with upper biliary obstruction (hilar level or above)
- Patients with other major biliary lesions in addition to malignant distal biliary obstruction
- Patients for whom the investigator judges that study conduct or data collection would be markedly difficult
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang university Hospital
Seoul, Seoul, 06973
Woosun Choi, MD., PhD., +82-10-2223-5073, radiochoi527@cauhs.or.kr
Jinyoung Choi, MD, +82-10-2223-5073, hananox@cauhs.or.kr
About this study
Official title: 12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction: A Prospective, Randomized Clinical Study
Metallic stents are commonly used for biliary drainage in patients with unresectable malignant distal biliary obstruction. However, it is unclear whether a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent provides better effectiveness and safety. This prospective, randomized clinical trial will compare these two stent types in adult patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) and are scheduled for metallic stent placement through the existing PTBD tract. A total of 60 participants will be enrolled. After stent placement, participants will be followed for 12 months, with assessments at 3, 6, and 12 months. The study will evaluate recurrent biliary obstruction, stent patency duration, reintervention, overall survival, and procedure-related complications. The results are expected to provide evidence for selecting the most appropriate 12-mm metallic stent for patients with unresectable malignant distal biliary obstruction.
Read the detailed description
Malignant distal biliary obstruction is commonly caused by pancreatic cancer, cholangiocarcinoma, gallbladder cancer, or metastatic malignancy. In patients with unresectable disease, biliary drainage with a self-expandable metallic stent is widely used as palliative treatment. Bare metallic stents have the advantage of firm fixation, but tumor ingrowth can lead to recurrent biliary obstruction. Covered metallic stents may reduce tumor ingrowth, but concerns remain regarding stent migration and other procedure-related complications. Although 10-mm stents have been studied previously, evidence remains limited regarding the comparative effectiveness and safety of 12-mm partially covered versus bare self-expandable metallic stents.
This study is a prospective, single-center, randomized clinical trial designed to compare a 12-mm partially covered self-expandable metallic stent with a 12-mm bare self-expandable metallic stent in patients with unresectable malignant distal biliary obstruction. Adult patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) according to the institutional clinical protocol and are scheduled for metallic stent placement through the existing PTBD tract will be screened for eligibility. After written informed consent is obtained, eligible participants will be randomly assigned in a 1:1 ratio to receive either a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent.
All procedures will be performed through a percutaneous transhepatic approach using the existing PTBD tract. After assessment of the biliary stricture, an appropriately sized 12-mm metallic stent will be placed. Participants will be followed for 12 months after stent placement, with follow-up assessments at 3, 6, and 12 months. The primary outcome is the cumulative incidence of recurrent biliary obstruction within 12 months after the procedure. Secondary outcomes include time to recurrent biliary obstruction, overall recurrent biliary obstruction rate, causes of recurrent biliary obstruction, reintervention, overall survival, and procedure-related complications such as pancreatitis, cholecystitis, bleeding, perforation, and cholangitis. The results of this study are expected to provide evidence to guide selection of the most appropriate 12-mm metallic stent in patients with unresectable malignant distal biliary obstruction.
- Being tested
- 12-mm partially covered self-expandable metallic stent, 12-mm bare self-expandable metallic stent
- Keywords
- 12-mm metallic stent, partially covered self-expandable metallic stent, bare self-expandable metallic stent, malignant distal biliary obstruction, PTBD, recurrent biliary obstruction, stent patency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-mm partially covered self-expandable metallic stentDevice
A 12-mm partially covered self-expandable metallic stent placed through the existing percutaneous transhepatic biliary drainage (PTBD) tract for internal biliary drainage in patients with unresectable malignant distal biliary obstruction.
12-mm bare self-expandable metallic stentDevice
A 12-mm bare self-expandable metallic stent placed through the existing percutaneous transhepatic biliary drainage (PTBD) tract for internal biliary drainage in patients with unresectable malignant distal biliary obstruction.
| Study group | Role | What they receive |
|---|---|---|
| 12-mm Partially Covered SEMS Group | Experimental | Participants in this arm will receive a 12-mm partially covered self-expandable metallic stent (ComVi Biliary Stent) through the existing PTBD tract for unresectable malignant distal biliary obstruction. Receives: Device: 12-mm partially covered self-expandable metallic stent |
| 12-mm Bare SEMS Group | Active comparator | Participants in this arm will receive a 12-mm bare self-expandable metallic stent (Niti-S Biliary Uncovered Stent) through the existing PTBD tract for unresectable malignant distal biliary obstruction. Receives: Device: 12-mm bare self-expandable metallic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of recurrent biliary obstruction (RBO) within 12 months after the procedure
Cumulative incidence of recurrent biliary obstruction related to the initially inserted study stent (index stent).
Measured: 12 months after the procedure
Secondary outcomes (7)
Time to recurrent biliary obstruction (Time to RBO; stent patency duration)
Time from the procedure to recurrent biliary obstruction of the initially inserted study stent (index stent); stent patency duration.
Measured: Up to 12 months after the procedure
Overall rate of recurrent biliary obstruction (RBO)
Overall rate of recurrent biliary obstruction during follow-up.
Measured: Up to 12 months after the procedure
Number of participants by cause of recurrent biliary obstruction
Number of participants with recurrent biliary obstruction classified by cause, including tumor ingrowth, tumor overgrowth, sludge, and stent migration.
Measured: Up to 12 months after the procedure
Rate of reintervention
Rate of participants requiring reintervention, including additional metallic stent p
Measured: Up to 12 months after the procedure
Number of reinterventions
Total number of reinterventions, including additional metallic stent placement, PTBD exchange, or PTBD extension.
Measured: Up to 12 months after the procedure
Overall survival
Overall survival after the procedure.
Measured: Up to 12 months after the procedure
Rate of procedure-related complications
Procedure-related complications, including pancreatitis, cholecystitis, bleeding, perforation, and cholangitis.
Measured: From immediately after the procedure up to 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start27 May 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Distal Biliary ObstructionStudies 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups receiving either a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- OSYMED CO., Ltd.
- Responsible party
- Principal investigator, Woosun Choi, Chung-Ang University Hospital
- Investigators
- Woosun Choi, MD, PhD, Principal investigator, Associate Professor, Department of Radiology, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559968
- Sponsor's protocol ID
- 2603-004-677
- Acronym
- PCSEMS-12
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction: A Prospective, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07559968
- Acronym / sponsor ID
- PCSEMS-12 / 2603-004-677
- Keywords
- 12-mm metallic stent, partially covered self-expandable metallic stent, bare self-expandable metallic stent, malignant distal biliary obstruction, PTBD, recurrent biliary obstruction, stent patency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Collaborators
- OSYMED CO., Ltd.
- Study start
- 27 May 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Apr 2026 (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.
Metallic stents are commonly used for biliary drainage in patients with unresectable malignant distal biliary obstruction. However, it is unclear whether a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent provides better effectiveness and safety. This prospective, randomized clinical trial will compare these two stent types in adult patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) and are scheduled for metallic stent placement through the existing PTBD tract. A total of 60 participants will be enrolled. After stent placement, participants will be followed for 12 months, with assessments at 3, 6, and 12 months. The study will evaluate recurrent biliary obstruction, stent patency duration, reintervention, overall survival, and procedure-related complications. The results are expected to provide evidence for selecting the most appropriate 12-mm metallic stent for patients with unresectable malignant distal biliary obstruction.
Detailed description
Malignant distal biliary obstruction is commonly caused by pancreatic cancer, cholangiocarcinoma, gallbladder cancer, or metastatic malignancy. In patients with unresectable disease, biliary drainage with a self-expandable metallic stent is widely used as palliative treatment. Bare metallic stents have the advantage of firm fixation, but tumor ingrowth can lead to recurrent biliary obstruction. Covered metallic stents may reduce tumor ingrowth, but concerns remain regarding stent migration and other procedure-related complications. Although 10-mm stents have been studied previously, evidence remains limited regarding the comparative effectiveness and safety of 12-mm partially covered versus bare self-expandable metallic stents.
This study is a prospective, single-center, randomized clinical trial designed to compare a 12-mm partially covered self-expandable metallic stent with a 12-mm bare self-expandable metallic stent in patients with unresectable malignant distal biliary obstruction. Adult patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) according to the institutional clinical protocol and are scheduled for metallic stent placement through the existing PTBD tract will be screened for eligibility. After written informed consent is obtained, eligible participants will be randomly assigned in a 1:1 ratio to receive either a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent.
All procedures will be performed through a percutaneous transhepatic approach using the existing PTBD tract. After assessment of the biliary stricture, an appropriately sized 12-mm metallic stent will be placed. Participants will be followed for 12 months after stent placement, with follow-up assessments at 3, 6, and 12 months. The primary outcome is the cumulative incidence of recurrent biliary obstruction within 12 months after the procedure. Secondary outcomes include time to recurrent biliary obstruction, overall recurrent biliary obstruction rate, causes of recurrent biliary obstruction, reintervention, overall survival, and procedure-related complications such as pancreatitis, cholecystitis, bleeding, perforation, and cholangitis. The results of this study are expected to provide evidence to guide selection of the most appropriate 12-mm metallic stent in patients with unresectable malignant distal biliary obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups receiving either a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent.
| Arm | Type | Receives |
|---|---|---|
| 12-mm Partially Covered SEMS Group | Experimental | Device: 12-mm partially covered self-expandable metallic stentParticipants in this arm will receive a 12-mm partially covered self-expandable metallic stent (ComVi Biliary Stent) through the existing PTBD tract for unresectable malignant distal biliary obstruction. |
| 12-mm Bare SEMS Group | Active comparator | Device: 12-mm bare self-expandable metallic stentParticipants in this arm will receive a 12-mm bare self-expandable metallic stent (Niti-S Biliary Uncovered Stent) through the existing PTBD tract for unresectable malignant distal biliary obstruction. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who voluntarily provide written informed consent after receiving sufficient explanation of the study purpose, methods, and potential benefits and risks
- Adults aged 19 years or older
- Patients diagnosed with unresectable malignant distal biliary obstruction based on imaging studies (CT, MRI, ERCP, etc.) or histologic confirmation
- Patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) according to the institutional clinical protocol and are scheduled for metallic stent placement through the existing PTBD tract
Key exclusion criteria (4 listed)
- Patients with a previous history of biliary metallic stent placement
- Patients with upper biliary obstruction (hilar level or above)
- Patients with other major biliary lesions in addition to malignant distal biliary obstruction
- Patients for whom the investigator judges that study conduct or data collection would be markedly difficult
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 |
|---|---|---|
| 12-mm partially covered self-expandable metallic stentA 12-mm partially covered self-expandable metallic stent placed through the existing percutaneous transhepatic biliary drainage (PTBD) tract for internal biliary drainage in patients with unresectable malignant distal biliary obstruction. | Device | 12-mm Partially Covered SEMS Group |
| 12-mm bare self-expandable metallic stentA 12-mm bare self-expandable metallic stent placed through the existing percutaneous transhepatic biliary drainage (PTBD) tract for internal biliary drainage in patients with unresectable malignant distal biliary obstruction. | Device | 12-mm Bare SEMS Group |
Primary outcome
Cumulative incidence of recurrent biliary obstruction (RBO) within 12 months after the procedure
Time frame: 12 months after the procedure
Cumulative incidence of recurrent biliary obstruction related to the initially inserted study stent (index stent).
7 secondary outcomes
Time to recurrent biliary obstruction (Time to RBO; stent patency duration)
Time frame: Up to 12 months after the procedure
Overall rate of recurrent biliary obstruction (RBO)
Time frame: Up to 12 months after the procedure
Number of participants by cause of recurrent biliary obstruction
Time frame: Up to 12 months after the procedure
Rate of reintervention
Time frame: Up to 12 months after the procedure
Number of reinterventions
Time frame: Up to 12 months after the procedure
Overall survival
Time frame: Up to 12 months after the procedure
Rate of procedure-related complications
Time frame: From immediately after the procedure up to 12 months after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Malignant Distal Biliary Obstruction
Recruiting
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
Malignant Biliary Obstruction, Malignant Biliary Stricture
Active, not recruiting
Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents
Pancreatic Cancer Non-resectable, Bile Duct Cancer
Not yet recruiting
EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)
Malignant Biliary Obstruction, Pancreatic Cancer
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.
Woosun Choi, MD, PhD principal investigator
Associate Professor, Department of Radiology, Chung-Ang 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 12-mm partially covered self-expandable metallic stent and 12-mm bare self-expandable metallic stent in people with Malignant Distal Biliary Obstruction and Malignant Biliary Obstruction, run by Chung-Ang 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 4 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Woosun Choi, MD, PhD (+82-2-6299-2681, radiochoi527@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of recurrent biliary obstruction (RBO) within 12 months after the procedure (time frame: 12 months after the 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 13 Jul 2026.