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Trial Title:
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma
NCT ID:
NCT05546372
Condition:
Perihilar Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Klatskin Tumor
Conditions: Keywords:
Endobiliary radiofrequency ablation
Stent patency
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Endobiliary radiofrequency ablation (eRFA)
Description:
Intraductal radiofrequency ablation of tumor prior to stent placement
Arm group label:
Endobiliary RFA + stent placement
Intervention type:
Device
Intervention name:
uncovered self-expanding metal stent (uSEMS)
Description:
Intraductal placement of uncovered metal stent
Arm group label:
Endobiliary RFA + stent placement
Arm group label:
Stent placement only
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amsterdam UMC location VUmc
Address:
City:
Amsterdam
Zip:
1081HV
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jeska Fritzsche, MD
Email:
j.a.fritzsche@amsterdamumc.nl
Start date:
November 9, 2023
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Source:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05546372
