Clinical trial · Interventional
PTFE Stents for Treatment of Malignant Biliary Strictures
Randomized Comparative Study of Novel PTFE-coated Stents (Hilzo) Versus Standard Silicone-coated Metal Stents (cSEMS) in Distal Malignant DHC Stenosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this randomized trial two two self-expanding metal stents (SEMS) for treatment of malignant biliary strictures are investigated. A newly developed PTFE (Polytetrafluorethylen) (Teflon) stent is tested versus standard covered metal stents. PFTE (Teflon) coating promises improved formability over standard silicone-coated stents, easier removal through the soft surface, and significantly reduced tumor growth through the impermeable surface.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Bile Duct Stricture | — | UNRESOLVED | — |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stenting with PTFE-coated stent (HILZO) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stenting with PTFE-coated stent (HILZO)
- description
- The bile duct is stented with a PTFE-coated stent by duodenoscopy to allow bile duct flow
- interventionNames
- Device: Stenting with PTFE-coated stent (HILZO)
- type
- ACTIVE_COMPARATOR
- label
- Stenting standard silicone coated stent
- description
- The bile duct is stented with a standard silicone-coated stent by duodenoscopy to allow bile duct flow
- interventionNames
- Device: Stenting with PTFE-coated stent (HILZO)
Primary outcomes (1)
- measure
- Stent migration
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: • Indication for the palliative metal-stent system for malignant stenosis of the distal DHC (bile duct tumors, pancreatic carcinoma, papillary carcinoma, lymphoma, lymph node metastases in the hilum) Exclusion Criteria: * Age under 18 years * Pregnancy * Contraindication to an endoscopic examination * Life expectancy under 3 months
References
Publications (0)
Data not yet available