Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma (RACCOON)

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

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 Overview

• Status: Recruiting
• Conditions: Perihilar Cholangiocarcinoma
• Intervention / Treatment: Device: Endobiliary radiofrequency ablation (eRFA); Device: uncovered self-expanding metal stent (uSEMS)

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeska Fritzsche; Phone Number: +31204440613; Email: j.a.fritzsche@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1081HV
    • Recruiting
    • Amsterdam UMC Location VUMC
    • Contact: Jeska Fritzsche, MD; Email: j.a.fritzsche@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endobiliary RFA + stent placement	Device: Endobiliary radiofrequency ablation (eRFA); Intraductal radiofrequency ablation of tumor prior to stent placement; Device: uncovered self-expanding metal stent (uSEMS); Intraductal placement of uncovered metal stent
Active Comparator: Stent placement only	Device: uncovered self-expanding metal stent (uSEMS); Intraductal placement of uncovered metal stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Anticipated): November 9, 2023
• Primary Completion (Anticipated): March 31, 2026
• Study Completion (Anticipated): March 31, 2026

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Endobiliary radiofrequency ablation; Stent patency
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Klatskin Tumor
• Other Study ID Numbers: NL76591.029.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No