A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions

Risks, Safety, and Outcomes of Temperature-sensitive Endobiliary Radiofrequency Ablation in Patients With Malignant Biliary Obstructions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05826639

Enrollment

176

Registered

2023-04-24

Start date

2023-04-13

Completion date

2024-11-18

Last updated

2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Stricture

Keywords

Bile duct obstruction, Biliary stent, Temperature-Sensitive Radiofrequency Ablation (RFA)

Brief summary

The purpose of this study is to assess the impact of temperature-sensitive radiofrequency ablation (RFA) immediately before biliary stent placement on duration of biliary stent patency and re-intervention free survival. This is a research study meant to collect information to help other patients with malignant biliary strictures in the future.

Interventions

PROCEDURETemperature-sensitive radiofrequency ablation

Endobiliary radiofrequency ablation prior to ERCP-guided biliary stenting that utilizes a temperature-sensitive endobiliary RFA catheter

OTHERNo intervention

No intervention

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Malignant biliary stricture * participants have or will have a biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation (RFA) with placement of biliary stents * Patients with life expectancy greater than 3 months * Able to provide consent

Exclusion criteria

* Patients who are pregnant * Patients with cirrhosis * Patients with significant liver metastasis >30% on radiologic imaging suggestive of poor liver function that will not improve despite endoscopic drainage. * Patients who have undergone prior biliary decompression stents or percutaneous drainage that cannot be removed at time of ERCP and thus preclude effective RFA * Patients with altered anatomy unable to undergo conventional ERCP (i.e., history of Roux-en-Y gastric bypass)

Design outcomes

Primary

Measure	Time frame	Description
Stent patency	6 months	Duration of stent patency over the 6 month follow-up period
Re-intervention free survival	6 months	Duration of re-intervention free survival over the 6 month follow-up period
Mortality	6 months	Number of subject deaths following ERCP, over the 6-month follow-up period

Secondary

Measure	Time frame	Description
Adverse Events	6 months	Number of participants with treatment-related adverse events over the 6-month follow-up period
Time until first adverse event	6 months	Time (in days) from ERCP until first treatment-related adverse event, over the 6-month follow-up period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026