Clinical trial · Interventional
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial
NCT05546372CI-TRIAL-00112503RACCOONrecruitingN/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)
A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients 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 |
|---|---|---|---|
| Endobiliary radiofrequency ablation (eRFA) | Device | — | UNRESOLVED |
| uncovered self-expanding metal stent (uSEMS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endobiliary RFA + stent placement
- interventionNames
- Device: Endobiliary radiofrequency ablation (eRFA)
- Device: uncovered self-expanding metal stent (uSEMS)
- type
- ACTIVE_COMPARATOR
- label
- Stent placement only
- interventionNames
- Device: uncovered self-expanding metal stent (uSEMS)
Primary outcomes (1)
- measure
- Time to biliary obstruction
- timeFrame
- Through study completion, max 1 year
- description
- Defined as period between initial procedure and recurrence of biliary obstruction. Recurrence of biliary obstruction is defined as recurrent jaundice (conjugated bilirubin ≥ 40 umol/l (≥2.3 mg/dl)), presence of biochemical evidence of cholestasis along with dilatation of the drained bile duct(s), or endoscopic findings suggesting stent occlusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older. * Capable of providing written and oral informed consent. * Histological or cytological proof of perihilar CCA (adenocarcinoma). * Perihilar biliary obstruction with an indication for drainage with uSEMS.\* * Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2) involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT). * Only patients with pCCA are eligible however in case of reasonable doubt between intrahepatic CCA with a perihilar biliary obstruction or massforming pCCA, patients can be included. Exclusion Criteria: * Patients who potentially qualify for curative resection of pCCA. * pCCA eligible for liver transplantation. * Life-expectancy less than 3 months. * ERCP and PTC technically not feasible. * Uncontrolled coagulopathy (PTT \>1,5x prolonged or thrombocytes below 40\*10E9/L). * Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and/or liver abscess at least 7 days. * Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study. * Patients who are pregnant or breastfeeding.
References
Publications (0)
Data not yet available
No reference posted for this study.