Clinical trial · Interventional
Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma
A Combined Endoscopy and Radiology-guided Radiofrequency Ablation Therapy Protocol for Inoperable Perihilar Cholangiocarcinoma
NCT05563870CI-TRIAL-00119674COMBO-RFAcompletedN/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)
This prospective clinical trial aims to assess the feasibility, efficacy, and safety of a personalized radiofrequency ablation protocol coupled with complete biliary drainage for patients presenting with inoperable perihilar cholangiocarcinoma.
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 |
|---|---|---|---|
| Perihilar Cholangiocarcinoma | Hilar Cholangiocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoluminal radiofrequency ablation | Procedure | — | UNRESOLVED |
| Endoscopic biliary stenting | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic Drainage Arm
- description
- Patients randomized to this arm will undergo biliary stenting only
- interventionNames
- Procedure: Endoscopic biliary stenting
- type
- EXPERIMENTAL
- label
- COMBO-RFA Arm
- description
- Patients randomized to this arm will undergo same-session endoluminal radiofrequency ablation followed by biliary stenting
- interventionNames
- Procedure: Endoluminal radiofrequency ablation
- Procedure: Endoscopic biliary stenting
Primary outcomes (2)
- measure
- Technical success of ERCP procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * perihilar cholangiocarcinoma * locally advanced disease (unresectable) * M1 (limted to 1 site) Exclusion Criteria: * refusal to sogn the ICF * poor performance status (ECOG \>2) * surgically altered anatomy (i.e Bilroth II or Roux-en-Y interventions) * significant comorbidities * ASA score \>3 * life expectancy \<3 months
References
Publications (0)
Data not yet available
No reference posted for this study.