Clinical trial · Interventional
Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma
Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial
NCT00721175CI-TRIAL-00005971completedPhase 4Results postedClinicalTrials.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 is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.
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 |
|---|---|---|---|
| Hilar Cholangiocarcinoma | Hilar Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biliary stent (self expandable metallic stent) | Device | — | UNRESOLVED |
| PS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SEMS
- description
- self-expandable metal stent group
- interventionNames
- Device: biliary stent (self expandable metallic stent)
- type
- ACTIVE_COMPARATOR
- label
- PS
- description
- plastic stent group
- interventionNames
- Device: PS
Primary outcomes (2)
- measure
- Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)
- timeFrame
- at 2 weeks and 4 weeks after stent insertion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable complex hilar cholangiocarcinoma which diagnosis and staging based on computed tomography(CT) or magnetic resonance cholangiopancreatography (MRCP) Exclusion Criteria: * Patients with ASA 4 or 5 * Patients with liver failure. * Patients unable to comply with follow-up
References
Publications (4)
- BACKGROUNDDe Palma GD, Pezzullo A, Rega M, Persico M, Patrone F, Mastantuono L, Persico G. Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study. Gastrointest Endosc. 2003 Jul;58(1):50-3. doi: 10.1067/mge.2003.310. PMID 12838220
- BACKGROUNDWagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy. 1993 Mar;25(3):213-8. doi: 10.1055/s-2007-1010295. PMID 7686100
- BACKGROUNDFreeman ML, Overby C. Selective MRCP and CT-targeted drainage of malignant hilar biliary obstruction with self-expanding metallic stents. Gastrointest Endosc. 2003 Jul;58(1):41-9. doi: 10.1067/mge.2003.292. PMID 12838219
- DERIVEDSangchan A, Kongkasame W, Pugkhem A, Jenwitheesuk K, Mairiang P. Efficacy of metal and plastic stents in unresectable complex hilar cholangiocarcinoma: a randomized controlled trial. Gastrointest Endosc. 2012 Jul;76(1):93-9. doi: 10.1016/j.gie.2012.02.048. Epub 2012 May 15. PMID 22595446