Clinical trial · Interventional
Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma
A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma
NCT01739465CI-TRIAL-00009558unknownPhase 2 / Phase 3ClinicalTrials.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 endoscopic radiofrequency ablation with photodynamic therapy for inoperable 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 |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic radiofrequency ablation (ERFA) | Procedure | — | UNRESOLVED |
| Photodynamic therapy (PDT) | Procedure | — | UNRESOLVED |
| Self expanding metallic stent (SEMS) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Self expanding metallic stent （SEMS ）placement only
- description
- Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing
- interventionNames
- Procedure: Self expanding metallic stent (SEMS)
- type
- EXPERIMENTAL
- label
- Endoscopic radiofrequency ablation plus SEMS
- description
- Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. The radiofrequency ablation (RFA) catheter (EMcision, London, United Kingdom) would be placed under fluoroscopic guidance across the biliary stricture. Radiofrequency energy will be delivered to the malignant site. After that,A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing
- interventionNames
- Procedure: Self expanding metallic stent (SEMS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old * Pathologically or radiologically confirmed biliary malignant * Inoperability by staging Exclusion Criteria: * Cholangiocarcinoma with widespread metastasis * Coagulopathy (INR \> 2.0 or prothrombin time \> 100 sec or platelet count \< 50,000) * Prior SEMS placement * Pregnancy * Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 ) * Life expectancy \< 3months
References
Publications (0)
Data not yet available
No reference posted for this study.