NCT05563870

Brief Summary

This prospective clinical trial aims to assess the feasibility, efficacy, and safety of a personalized radiofrequency ablation protocol coupled with complete biliary drainage for patients presenting with inoperable perihilar cholangiocarcinoma.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

September 20, 2022

Last Update Submit

March 25, 2024

Conditions

Perihilar Cholangiocarcinoma

Keywords

perihilar cholangiocarcinomaERCPRadiofrequency ablation

Outcome Measures

Primary Outcomes (2)

  • Technical success of ERCP procedure

    Ability to correctly apply radiofrequency ablation and place stents in all the biliary ducts accessed on ERCP

    2 months

  • Tumor response

    To evaluate the efficacy of radiofrequency ablation in local disease control by assessing tumor response according to RECIST criteria at 6 months follow-up

    6 months

Secondary Outcomes (3)

  • Rate of procedure-related adverse events

    12 months

  • Overall survival

    12 months

  • Tumor microenvironment alterations

    2 months

Study Arms (2)

Endoscopic Drainage Arm

ACTIVE COMPARATOR

Patients randomized to this arm will undergo biliary stenting only

Procedure: Endoscopic biliary stenting

COMBO-RFA Arm

EXPERIMENTAL

Patients randomized to this arm will undergo same-session endoluminal radiofrequency ablation followed by biliary stenting

Procedure: Endoluminal radiofrequency ablationProcedure: Endoscopic biliary stenting

Interventions

Endoluminal radiofrequency ablationPROCEDURE

Endoluminal Radiofrequency ablation (RFA) of the entire stricture length will be performed using the Habib probe. A current of 7W will be delivered for 90s intervals at a time. If multiple ablation sessions are needed in order to ablate the entire stricture lenght, there will be an overlap of ablated areas in order to ensure proper stricture treatment. Dilation of the stricture prior to RFA delivery will be performed if required. After RFA treatment, biliary drainage of all hepatic territories will be ensured.

COMBO-RFA Arm
Endoscopic biliary stentingPROCEDURE

Endoscopic biliary stenting will be performed via ERCP using multiple plastic stents, in order to ensure propper drainage of all accessed hepatic territories.

COMBO-RFA ArmEndoscopic Drainage Arm

Eligibility Criteria

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

You may qualify if:

  • perihilar cholangiocarcinoma
  • locally advanced disease (unresectable)
  • M1 (limted to 1 site)

You may not qualify if:

  • refusal to sogn the ICF
  • poor performance status (ECOG \>2)
  • surgically altered anatomy (i.e Bilroth II or Roux-en-Y interventions)
  • significant comorbidities
  • ASA score \>3
  • life expectancy \<3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology Department, Colentina Hospital

Bucharest, 020125, Romania

Location

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterology Consultant

Study Record Dates

First Submitted

September 20, 2022

First Posted

October 3, 2022

Study Start

August 1, 2022

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)