A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions

Mayo Clinic

Status: Completed

Conditions: Biliary Stricture

Treatments: Procedure: Temperature-sensitive radiofrequency ablation; Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05826639

22-005206

NCI-2024-02188 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

176 participants in 2 patient groups

Temperature-sensitive RFA prior to biliary stenting

Description:

Data will be collected on subjects undergoing endoscopic retrograde cholangiopancreatography (ERCP) with temperature-sensitive RFA prior to biliary stenting for treatment of malignant biliary strictures as part of clinical care.

Treatment:

Procedure: Temperature-sensitive radiofrequency ablation

Non-RFA biliary stenting for malignant biliary obstruction

Description:

Retrospective participants that have undergone non-RFA biliary stenting for malignant biliary obstruction from a historical cohort will serve as controls.

Treatment:

Other: No intervention