Clinical trial · Interventional
Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction
Treatment of Malignant Distal Biliary Obstruction - a Randomized Study
NCT03821025CI-TRIAL-00037174unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.
Conditions
Conditions (4)
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 Obstruction, Extrahepatic | — | UNRESOLVED | — |
| Biliary Stricture | — | UNRESOLVED | — |
| Cancer of the Bile Duct | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Cancer of the Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biliary stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Multiple Plastic Stents
- description
- Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture.
- interventionNames
- Device: Biliary stent
- type
- ACTIVE_COMPARATOR
- label
- Self-expandable Metal Stents
- description
- Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture
- interventionNames
- Device: Biliary stent
Primary outcomes (1)
- measure
- Number of patients without stent failure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18years of age or older * informed consent obtained after oral and written information * clinical data in accordance with a malignant bile duct obstruction * imaging evidence: (ultrasonography (US), computed tomography (CT) or magnetic resonance imaging (MRI) shows signs of extrahepatic malignant common bile duct obstruction * typical ERCP findings of a malignant common bile duct stenosis * proximal margin of the bile duct stenosis ≥2 cm from the hepatic confluence * bilirubin \> 50 micromol/L * radical surgery not deemed possible Exclusion Criteria: * patients with active hepatitis or other jaundice-causing hepatic diseases * informed consent not obtained or patient unable to give informed consent * patients with no understanding of English, Afrikaans or Xhosa where it is not possible to obtain informed consent * metastasis with multiple significant intrahepatic stenosis causing blockage of one or more segments of the liver (liver metastasis otherwise not an exclusion criteria) * the patient is a possible candidate for surgical resection * suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations) * the proximal end of the stenosis is \< 2 cm from the hepatic confluence * previous BII or Roux-en-Y gastric reconstruction * significant duodenal obstruction making ERCP difficult * previous bile duct stent
References
Publications (0)
Data not yet available
No reference posted for this study.