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

Primary Purpose

Perihilar Cholangiocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Endobiliary radiofrequency ablation (eRFA)
uncovered self-expanding metal stent (uSEMS)
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Perihilar Cholangiocarcinoma focused on measuring Endobiliary radiofrequency ablation, Stent patency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amsterdam UMC location VUmcRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endobiliary RFA + stent placement

Stent placement only

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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
Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage.
Need for external drainage catheters.
Time to re-intervention.
Stent patency after repeated eRFA.
Adverse events within 30 days after the procedu
Overall survival.
Healthcare costs.

Full Information

First Posted
August 25, 2022
Last Updated
October 25, 2022
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT05546372
Brief Title
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma
Acronym
RACCOON
Official Title
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2023 (Anticipated)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perihilar Cholangiocarcinoma
Keywords
Endobiliary radiofrequency ablation, Stent patency

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endobiliary RFA + stent placement
Arm Type
Experimental
Arm Title
Stent placement only
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Endobiliary radiofrequency ablation (eRFA)
Intervention Description
Intraductal radiofrequency ablation of tumor prior to stent placement
Intervention Type
Device
Intervention Name(s)
uncovered self-expanding metal stent (uSEMS)
Intervention Description
Intraductal placement of uncovered metal stent
Primary Outcome Measure Information:
Title
Time to biliary obstruction
Description
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.
Time Frame
Through study completion, max 1 year
Secondary Outcome Measure Information:
Title
Quality of life expressed in quality adjusted life-years (QALYs)
Description
EORTC QLQ-C30, BIL21 and EQ-5D questionnaires are to be filled out 4 weeks and every3 months after the intervention
Time Frame
Through study completion, max 1 year
Title
Number of patients with technical success of initial ablation
Description
Defined as completion of ablation of the malignant stenosis through which the stent will be placed using RFA for 120 seconds with 7W.
Time Frame
During intervention
Title
Number of patients with functional success
Description
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.
Time Frame
14 days
Title
Presumed reason of recurrent biliary obstruction
Description
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
Time Frame
Through study completion, an average of 1 year
Title
Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage.
Time Frame
Through study completion, an average of 1 year
Title
Need for external drainage catheters.
Time Frame
Through study completion, an average of 1 year
Title
Time to re-intervention.
Time Frame
Through study completion, an average of 1 year
Title
Stent patency after repeated eRFA.
Time Frame
Through study completion, an average of 1 year
Title
Adverse events within 30 days after the procedu
Time Frame
30 days
Title
Overall survival.
Time Frame
Through study completion
Title
Healthcare costs.
Time Frame
Through study completion, max 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeska Fritzsche
Phone
+31204440613
Email
j.a.fritzsche@amsterdamumc.nl
Facility Information:
Facility Name
Amsterdam UMC location VUmc
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeska Fritzsche, MD
Email
j.a.fritzsche@amsterdamumc.nl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

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