Clinical trial · Interventional
Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC
Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable Hepatocellular Carcinoma: A Prospective Cohort Study
NCT05729867CI-TRIAL-00064009unknownN/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 effectiveness and safety of fully covered metal stent in malignant biliary obstruction caused by HCC are still unknown. These would be clarified in this prospective cohort study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Biliary Obstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscpic biliary drainage using fully covered metal stent | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- fully covered self-expanable metal stent with HCC
- description
- This prospective cohort is comprised of patients with malignant biliary obstruction caused by hepatocellular carcinoma who were treated with endoscopic biliary drainage using fully covered self expandable metal stent.
- interventionNames
- Procedure: Endoscpic biliary drainage using fully covered metal stent
Primary outcomes (2)
- measure
- Clinical success rate
- timeFrame
- 1 month
- description
- Clinical success rate is defined as a reduction of total bilirubin level above 50% or total bilirubin level less than 2 mg/dL within 1 month after the procedure. Clinical success rate of all procedures will be measured.
- measure
- Technical success rate
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 19 years or older, those who consented to the clinical research participation and signed a written consent form * Obstructive jaundice caused by unresectable hepatocellular carcinoma Exclusion Criteria: * Patients who have previously undergone surgical biliary drainage * Patients who need to remain percutaneous transhepatic biliary drainage * Patients whose life expectancy is less than 3 months (BCLC stage D without a treatment plan for hepatocellular carcinoma) * Patients who cannot undergo endoscopic procedure according to the judgment of the researcher
References
Publications (0)
Data not yet available
No reference posted for this study.