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.
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.*
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.
Parallel
Endobiliary radiofrequency ablation (eRFA)
DeviceIntraductal radiofrequency ablation of tumor prior to stent placement
uncovered self-expanding metal stent (uSEMS)
DeviceIntraductal placement of uncovered metal stent
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.
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
Number of patients with technical success of initial ablation
Defined as completion of ablation of the malignant stenosis through which the stent will be placed using RFA for 120 seconds with 7W.
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.
Presumed reason of recurrent biliary obstruction
1. Stent occlusion due to tumour ingrowth 2. Stent occlusion due to tumour overgrowth 3. Stent occlusion due to sludge with/or without stones, hemobilia, food impaction 4. Stent migration
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Erasmus Medical Center
Collaborator
Leiden University Medical Center
Collaborator
UMC Utrecht
Collaborator
University Medical Center Groningen
Collaborator
St. Antonius Hospital
Collaborator
Medisch Spectrum Twente
Collaborator
Maastricht University Medical Center
Collaborator
Clinical Hospital Colentina
Collaborator
University Hospital Prague (IKEM), Prague, Czech Republic
Collaborator
Orlando Health, Inc.
Collaborator
University Hospital, Ghent
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
