Biodegradable balloon-expandable biliary stent for benign and malignant bile duct strictures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm study evaluating the safety and performance of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in patients with biliary strictures. The primary goal is to determine safety, while secondary goals include technical and clinical success, quality of life, and the rate of stent biodegradation. The rationale is to use a temporary, removable stent that may reduce the need for stent removal and minimize ductal injury compared to plastic or metal stents. The study builds on prior data suggesting biodegradables can maintain duct patency during healing and eventually degrade without significant tissue reaction. Subjects will undergo biliary duct stenting as the intervention, with follow-up to assess outcomes and any adverse events.

Why it matters

Who can join: the full rules

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.

    \-

Where it's running

• Queen Mary Hospital
  Hong Kong, Hong Kong Recruiting
• AIG Hospitals (Asian Institute of Gastroenterology)
  Hyderabad, India Recruiting
• Sunway Medical Centre
  Kuala Lumpur, Malaysia Recruiting
• University Malaya Medical Centre (UMMC)Clinical Investigation Centre (CIC)
  Kuala Lumpur, Malaysia Recruiting
• The Prince of Wales Hospital
  Hong Kong, Hong Kong Enrolling by invitation
• Universityi Kebangsaan Malaysia (UKM)
  Kuala Lumpur, Malaysia Completed

Study contacts

• Study coordinator: Hairol Azrin bin Othman, MD
• Email: hairol@gmail.com
• Phone: 60374919191

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EUS-guided pancreaticobiliary procedures with the RIVOS access device

  This study tests how the RIVOS EUS access device performs during interventional procedures for pancreatic and bile duct problems in adults.

  Recruiting Orlando Health, Inc. · Orlando, Florida · NCT07696572

• Sedation Methods in PTBD: How Two Regimens Compare for Quality and Recovery

  This study tests two sedation plans (propofol with remifentanil vs propofol with ketamine) to see which helps patients recover faster after PTBD while staying comfortable and safe.

  Recruiting Ankara City Hospital Bilkent · Ankara, Ankara · NCT07640243

• 12-mm Partially Covered vs Bare Self-Expandable Stents for Malignant Distal Biliary Obstruction

  This study tests whether a 12-mm partially covered self-expandable stent works better than a 12-mm bare self-expandable stent for patients with unresectable malignant distal biliary obstruction who have already had PTBD.

  Recruiting Chung-Ang University Hospital · Seoul, Seoul · NCT07559968

• Intraductal antibiotic given during ERCP for acute cholangitis

  This trial tests whether putting an antibiotic directly into the bile ducts during ERCP, together with standard IV antibiotics, helps adults with mild-to-moderate acute cholangitis recover faster and avoid worsening infection compared with IV antibiotics alone.

  Recruiting Phase 2 National University of Malaysia · Cheras, Kuala Lumpur · NCT07407491

• How quickly blood albumin returns after major liver, pancreas, or bile-duct surgery predicts recovery

  This study will see if the speed at which serum albumin returns after major hepato‑pancreato‑biliary surgery predicts complications and hospital stay for patients aged 12 and up.

  Recruiting Institute of Liver and Biliary Sciences, India · New Delhi, National Capital Territory of Delhi · NCT07263061

• Mechanical versus electrocautery dilator for EUS-guided biliary drainage

  This trial will test whether using a mechanical dilator instead of an electrocautery dilator reduces bleeding during EUS-guided biliary drainage for patients with biliary obstruction after failed ERCP.

  Recruiting National Taiwan University Hospital · Taipei · NCT06620328

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.