No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
19 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Chung-Ang University Hospital · Other
Who this trial is looking for
This trial is looking for adults who have difficulty with bile flow due to a specific type of cancer. Participants will have a type of stent placed and will be monitored over 12 months to see how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I am 19 years or older.
I have been diagnosed with unresectable malignant distal biliary obstruction.
I have undergone percutaneous transhepatic biliary drainage (PTBD).
I can provide written consent to participate in the trial.
You may not be able to join if
I have had a biliary metallic stent placed before.
I have upper biliary obstruction.
I have other major biliary lesions along with malignant distal biliary obstruction.
The study team thinks it would be hard for me to participate.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
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