Clinical trial NCT05546372: Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma
Official title: Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perihilar Cholangiocarcinoma
Keywords: Endobiliary radiofrequency ablation
Stent patency
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Time to biliary obstruction
timeFrame: Through study completion, max 1 year
Secondary outcomes:
measure: Quality of life expressed in quality adjusted life-years (QALYs)
timeFrame: Through study completion, max 1 year
measure: Number of patients with technical success of initial ablation
timeFrame: During intervention
measure: Number of patients with functional success
timeFrame: 14 days
measure: Presumed reason of recurrent biliary obstruction
timeFrame: Through study completion, an average of 1 year
measure: Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage.
timeFrame: Through study completion, an average of 1 year
measure: Need for external drainage catheters.
timeFrame: Through study completion, an average of 1 year
measure: Time to re-intervention.
timeFrame: Through study completion, an average of 1 year
measure: Stent patency after repeated eRFA.
timeFrame: Through study completion, an average of 1 year
measure: Adverse events within 30 days after the procedu
timeFrame: 30 days
measure: Overall survival.
timeFrame: Through study completion
measure: Healthcare costs.
timeFrame: Through study completion, max 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location VUmc
Study officials:
References: