NCT05546372

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 9, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

August 25, 2022

Last Update Submit

October 25, 2022

Conditions

Perihilar Cholangiocarcinoma

Keywords

Endobiliary radiofrequency ablationStent patency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Quality of life expressed in quality adjusted life-years (QALYs)

    Through study completion, max 1 year

  • Number of patients with technical success of initial ablation

    During intervention

  • Number of patients with functional success

    14 days

  • Presumed reason of recurrent biliary obstruction

    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

  • +6 more secondary outcomes

Study Arms (2)

Endobiliary RFA + stent placement

EXPERIMENTAL
Device: Endobiliary radiofrequency ablation (eRFA)Device: uncovered self-expanding metal stent (uSEMS)

Stent placement only

ACTIVE COMPARATOR
Device: uncovered self-expanding metal stent (uSEMS)

Interventions

Endobiliary radiofrequency ablation (eRFA)DEVICE

Intraductal radiofrequency ablation of tumor prior to stent placement

Endobiliary RFA + stent placement
uncovered self-expanding metal stent (uSEMS)DEVICE

Intraductal placement of uncovered metal stent

Endobiliary RFA + stent placementStent placement only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC location VUmc

Amsterdam, 1081HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Jeska Fritzsche

CONTACT

+31204440613j.a.fritzsche@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2022

First Posted

September 19, 2022

Study Start

November 9, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

October 27, 2022

Record last verified: 2022-10

Locations

NL(1)