Phase 4
N=108
Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma
Hilar Cholangiocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00721175 ↗Enrolled (actual)
108
Serious AEs
32.4%
Results posted
Dec 2011
Primary outcome: Primary: Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis) — .7037037; .46296 proportion of participants — p=0.011
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- biliary stent (self expandable metallic stent) (Device); PS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Khon Kaen University
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis) |
.7037037; .46296 | 0.011 sig |
| PRIMARY Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis) |
0.822; 0.543 | 0.004 sig |
| SECONDARY Patients Survival Times |
126; 49 | 0.0021 sig |
| SECONDARY Cost Effective Ratio of Metallic and Plastic Stent |
10742; 19085 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00721175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.