Perihilar Cholangiocarcinoma
Conditions
Keywords
Endobiliary radiofrequency ablation, Stent patency
Brief summary
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.
Interventions
DEVICEEndobiliary radiofrequency ablation (eRFA)
Intraductal radiofrequency ablation of tumor prior to stent placement
DEVICEuncovered self-expanding metal stent (uSEMS)
Intraductal placement of uncovered metal stent
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
Leiden University Medical Center
UMC Utrecht
University Medical Center Groningen
St. Antonius Hospital
Medisch Spectrum Twente
Maastricht University Medical Center
Clinical Hospital Colentina
University Hospital Prague (IKEM), Prague, Czech Republic
Orlando Health, Inc.
University Hospital, Ghent
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to biliary obstruction | Through study completion, max 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life expressed in quality adjusted life-years (QALYs) | Through study completion, max 1 year | 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 | During intervention | 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 | 14 days | 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 | Through study completion, an average of 1 year | 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 |
| 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 | — |
Countries
Netherlands
Contacts
CONTACTEsmée Smit
Outcome results
None listed