Dissolving stent could unblock bile ducts without extra surgery
NCT ID NCT04929821
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new stent that slowly dissolves over time to open narrowed or blocked bile ducts. About 100 people with bile duct strictures will receive the stent during a routine procedure. Researchers will track safety, how well the stent works, and whether patients feel better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- biodegradable balloon-expandable biliary stent
- What this could lead to
- If successful, this could provide a safer, temporary way to open blocked bile ducts without needing a second procedure to remove the stent.
- What could go wrong
- This is an early feasibility study with only 100 participants, so results may not apply to everyone. Risks include infection, stent migration, or blockage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2017
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\) A subject with a biliary stricture may be entered into the study with: at least one of the following: * Benign fibrotic distal bile duct obstruction * Duct occlusion caused by cholelithiasis * A benign fibrotic distal obstruction of the Common Bile Duct (CBD), demonstrated by presence of a stenosis on magnetic resonance cholangiopancreatography (MRCP) and/or ERCP with proximal ductal dilation and cholestatic liver enzymes levels * Ductal anastomotic strictures * Malignant Biliary stricture at least 1 cm distal to the hilum as well as periampullary hilar strictures not involving the papilla. * Neoplasm diagnosed on clinical and imaging findings * Post-ERCP pancreatitis * Obstructive jaundice with evidence of pruritus, tea color urine and pale stool * Abnormal Bilirubin rate or * A planned exchange of plastic stents previously placed for management of symptomatic biliary stricture or * A previous Percutaneous Transhepatic Biliary Drainage (PTBD) for management of symptomatic biliary stricture 2) Age ≥ 18 years old Exclusion Criteria: Patients, male or female, presenting with the following criteria may be included: 1. Subject is unwilling to comply with the follow-up schedule 2. Life expectancy \< 12 m, 3. Inability to pass a guidewire through stricture 4. Contra-indication for endoscopy or interventional radiology 5. History of allergic reactions to one of the compounds of investigational product. 6. Subject is unable or refuses to give informed consent 7. Subject is pregnant or breastfeeding 8. Patient under tutorship 9. Currently participating in another trial before reaching first endpoint. 10. Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma 11. Patient need additional biliary stenting with another device than the study device. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AIG Hospitals (Asian Institute of Gastroenterology)
RECRUITINGHyderabad, 500032, India
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Queen Mary Hospital
RECRUITINGHong Kong, Hong Kong
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Sunway Medical Centre
RECRUITINGKuala Lumpur, 47500, Malaysia
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The Prince of Wales Hospital
ENROLLING_BY_INVITATIONHong Kong, Hong Kong
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University Malaya Medical Centre (UMMC)Clinical Investigation Centre (CIC)
RECRUITINGKuala Lumpur, 59100, Malaysia
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Universityi Kebangsaan Malaysia (UKM)
COMPLETEDKuala Lumpur, 56000, Malaysia
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