Clinical trial · Interventional
Winged Perimeter Versus Traditional Plastic Biliary Stent for Malignant Bile Duct Obstruction
A Randomized Trial Comparing a Winged Perimeter Stent and Traditional Polyethylene Plastic Stent in the Management of Malignant Distal Biliary Strictures
- 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)
Strictures in the bile duct cause a blockage of flow of bile. This leads to potential problems including jaundice, itch and infection in the bile duct. The usual first step in this situation would be to allow flow of bile by placing a stent across the stricture. This is usually done by a special type of endoscopy procedure called an endoscopic retrograde cholangiopancreatography, or ERCP. The most commonly used stent are made from a plastic material called polyethylene and has a central lumen in which bile drains through it. Health Canada has approved the sale and use of another stent with a winged perimeter (the VIADUCT stent) for placement in bile duct strictures and is used routinely in our hospitals. However, the investigators do not know which stent is better at treating bile duct strictures. In order to determine which stent would be more useful, the VIADUCT stent and the usual polyethylene flanged stent must be studied under carefully controlled circumstances. This will be done by a randomized, subject-blinded study. Other trials in the past have looked at other stents in this way, but this is the first time the VIADUCT stent has been looked at in this manner. The investigators suspect that the design of the VIADUCT stent will allow it to work for a longer period of time compared to the traditional polyethylene stent.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumor of Extrahepatic Bile Duct | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| traditional polyethylene stent insertion (Cotton Huibregtse) | Device | — | UNRESOLVED |
| WInged perimeter biliary stent insertion (Viaduct) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Winged perimeter stent
- description
- Patients who receive the Viaduct stent during ERCP
- interventionNames
- Device: WInged perimeter biliary stent insertion (Viaduct)
- type
- ACTIVE_COMPARATOR
- label
- polyethylene stent arm
- description
- Patient who receive the traditional polyethylene stent during ERCP
- interventionNames
- Device: traditional polyethylene stent insertion (Cotton Huibregtse)
Primary outcomes (1)
- measure
- Stent patency time
- timeFrame
- six months post stent insertion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \> 18 years of age * Bile duct stricture confirmed on cholangiography at ERCP * Malignant etiology confirmed on histology or cytology * Duct stricture is \> 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts) Exclusion Criteria: * Unable to obtain consent * Unable to tolerate procedure * Hilar strictures * Known benign biliary strictures and benign strictures confirmed after randomization * Circumstances where an alternative biliary stent (pigtail stent or metal stent) is deemed critical by the treating Gastroenterologist
References
Publications (1)
- BACKGROUNDRaju GS, Sud R, Elfert AA, Enaba M, Kalloo A, Pasricha PJ. Biliary drainage by using stents without a central lumen: a pilot study. Gastrointest Endosc. 2006 Feb;63(2):317-20. doi: 10.1016/j.gie.2005.07.053. PMID 16427942