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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
| Leiden University Medical Center | OTHER |
| UMC Utrecht | OTHER |
| University Medical Center Groningen |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endobiliary RFA + stent placement | Experimental |
| |
| Stent placement only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endobiliary radiofrequency ablation (eRFA) | Device | Intraductal radiofrequency ablation of tumor prior to stent placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to biliary obstruction | 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. | Through study completion, max 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life expressed in quality adjusted life-years (QALYs) | EORTC QLQ-C30, BIL21 and EQ-5D questionnaires are to be filled out 4 weeks and every3 months after the intervention | Through study completion, max 1 year |
| Number of patients with technical success of initial ablation |
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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).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esmée Smit | Contact | +31204440613 | e.smit1@amsterdamumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC location VUmc | Recruiting | Amsterdam | 1081HV | Netherlands |
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| OTHER |
| St. Antonius Hospital | OTHER |
| Medisch Spectrum Twente | OTHER |
| Maastricht University Medical Center | OTHER |
| Clinical Hospital Colentina | OTHER |
| University Hospital Prague (IKEM), Prague, Czech Republic | UNKNOWN |
| Orlando Health, Inc. | OTHER |
| University Hospital, Ghent | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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| uncovered self-expanding metal stent (uSEMS) | Device | Intraductal placement of uncovered metal stent |
|
Defined as completion of ablation of the malignant stenosis through which the stent will be placed using RFA for 120 seconds with 7W. |
| During intervention |
| Number of patients with functional success | In case of inadequate drainage prior to the procedure (bilirubin ≥40 umol/L [≥2.3 mg/dl]), defined as 50% decrease or normalization of bilirubin level within 14 days of the procedure or relieve of symptoms in case of cholangitis. In case of sufficient drainage prior to the procedure, a persistent bilirubin level <40 umol/L (<2.3 mg/dl) after 14 days is considered functional success. | 14 days |
| Presumed reason of recurrent biliary obstruction |
| Through study completion, an average of 1 year |
| Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage. | Through study completion, an average of 1 year |
| Need for external drainage catheters. | Through study completion, an average of 1 year |
| Time to re-intervention. | Through study completion, an average of 1 year |
| Stent patency after repeated eRFA. | Through study completion, an average of 1 year |
| Adverse events within 30 days after the procedu | 30 days |
| Overall survival. | Through study completion |
| Healthcare costs. | Through study completion, max 1 year |
| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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