Clinical trial · Interventional
Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction
Comparison of Metal Versus Plastic Side-by-side Stent Insertion in Malignant Hilar Biliary Obstruction
NCT03857958CI-TRIAL-00037931unknownN/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)
The purpose of this study was to compare the difference in the stent patency duration between side-by-side fully covered self-expanding metal stents (SEMS) and side-by-side plastic stents in patients with malignant hilar biliary obstruction.
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 Hepatobiliary Neoplasm | Malignant Hepatobiliary Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic retrograde cholangio-pancreatography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FCSEMS
- description
- In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In FCSEMS group, patients are inserted with Fully covered self-expandable metal stent (FCSEMS) bilaterally for malignant hilar biliary stricture via endoscopic retrograde cholangio-pancreatography.
- interventionNames
- Procedure: endoscopic retrograde cholangio-pancreatography
- type
- ACTIVE_COMPARATOR
- label
- Plastic stent
- description
- In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In plastic stent group, patients are inserted with plastic stents bilaterally for malignant hilar biliary stricture.
- interventionNames
- Procedure: endoscopic retrograde cholangio-pancreatography
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable malignant hilar biliary stricture requiring biliary drainage through endoscopic procedure Exclusion Criteria: * If endoscopy is not possible based on the judgement of the researcher * Life expectancy less than 6 months * Acute cholecystitis * Previous history of percutaneous transhepatic biliary drainage * Previous history of metal stent placement for malignant biliary stricture
References
Publications (0)
Data not yet available
No reference posted for this study.