Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-09

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endoscopic Biliary Co-axial Stent Placement Plus/Minus Use of Radiofrequency Ablation (RFA) for Clearance of Occluded Self Expandable Metal Stents (SEMS) in Patients With Distal Biliary Obstruction From Unresectable Biliary-pancreatic Malignancies

NCT02340728

Pancreatic Cancer Unresectable Biliary-pancreatic Malignancies

COMPLETED PHASE3

Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures

NCT01721174

Pancreatic Cancer Cholangiocarcinoma

TERMINATED NA

RFA for Malignant Biliary Obstruction

NCT03166436

Cholangiocarcinoma Pancreas Cancer

UNKNOWN NA

RFA RCT for Pancreatic or Bile Duct Cancer

NCT02166190

Unresectable Pancreatic Cancer Cholangiocarcinoma Non-resectable

TERMINATED NA

Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma

NCT04611100

Hilar Cholangiocarcinoma Biliary Obstruction

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perihilar Cholangiocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endobiliary RFA + stent placement

Group Type EXPERIMENTAL

Endobiliary radiofrequency ablation (eRFA)

Intervention Type DEVICE

Intraductal radiofrequency ablation of tumor prior to stent placement

uncovered self-expanding metal stent (uSEMS)

Intervention Type DEVICE

Intraductal placement of uncovered metal stent

Stent placement only

Group Type ACTIVE_COMPARATOR

uncovered self-expanding metal stent (uSEMS)

Intervention Type DEVICE

Intraductal placement of uncovered metal stent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endobiliary radiofrequency ablation (eRFA)

Intraductal radiofrequency ablation of tumor prior to stent placement

Intervention Type DEVICE

uncovered self-expanding metal stent (uSEMS)

Intraductal placement of uncovered metal stent

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No