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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
98
Intraductal radiofrequency ablation of tumor prior to stent placement
Intraductal placement of uncovered metal stent
Amsterdam UMC location VUmc
Amsterdam, Netherlands
RECRUITINGTime 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.
Time frame: Through study completion, max 1 year
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
Time frame: Through study completion, max 1 year
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.
Time frame: 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.
Time frame: 14 days
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
Time frame: Through study completion, an average of 1 year
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Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage.
Time frame: Through study completion, an average of 1 year
Need for external drainage catheters.
Time frame: Through study completion, an average of 1 year
Time to re-intervention.
Time frame: Through study completion, an average of 1 year
Stent patency after repeated eRFA.
Time frame: Through study completion, an average of 1 year
Adverse events within 30 days after the procedu
Time frame: 30 days
Overall survival.
Time frame: Through study completion
Healthcare costs.
Time frame: Through study completion, max 1 year