Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

Perihilar Cholangiocarcinoma Clinical Trial

— RACCOON  

Official title:

Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546372
• Other study ID #: NL76591.029.22
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: October 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Jeska Fritzsche
• Phone: +31204440613
• Email: j.a.fritzsche[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Klatskin Tumor
• Perihilar Cholangiocarcinoma

Intervention

Device:
• Endobiliary radiofrequency ablation (eRFA)
Intraductal radiofrequency ablation of tumor prior to stent placement
• uncovered self-expanding metal stent (uSEMS)
Intraductal placement of uncovered metal stent

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC location VUmc	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, max 1 year
Secondary	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	Through study completion, max 1 year
Secondary	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.	During intervention
Secondary	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.	14 days
Secondary	Presumed reason of recurrent biliary obstruction	Stent occlusion due to tumour ingrowth; Stent occlusion due to tumour overgrowth; Stent occlusion due to sludge with/or without stones, hemobilia, food impaction; Stent migration	Through study completion, an average of 1 year
Secondary	Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage.		Through study completion, an average of 1 year
Secondary	Need for external drainage catheters.		Through study completion, an average of 1 year
Secondary	Time to re-intervention.		Through study completion, an average of 1 year
Secondary	Stent patency after repeated eRFA.		Through study completion, an average of 1 year
Secondary	Adverse events within 30 days after the procedu		30 days
Secondary	Overall survival.		Through study completion
Secondary	Healthcare costs.		Through study completion, max 1 year