Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

Not Applicable

Recruiting

• Conditions: Perihilar Cholangiocarcinoma
• Interventions: Device: Endobiliary radiofrequency ablation (eRFA); Device: uncovered self-expanding metal stent (uSEMS)

• Registration Number: NCT05546372
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-19
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27
• Study Start: 2023-11-09
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endobiliary RFA + stent placement	Endobiliary radiofrequency ablation (eRFA)	-
Endobiliary RFA + stent placement	uncovered self-expanding metal stent (uSEMS)	-
Stent placement only	uncovered self-expanding metal stent (uSEMS)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Need for external drainage catheters.	Through study completion, an average of 1 year
Adverse events within 30 days after the procedu	30 days
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
Overall survival.	Through study completion
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.
Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage.	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
Healthcare costs.	Through study completion, max 1 year

Trial Locations

Locations (1)

Amsterdam UMC location VUmc; 🇳🇱 Amsterdam, Netherlands