A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions

Mayo Clinic176 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

176

Conditions

Biliary Stricture

Interventions

Temperature-sensitive radiofrequency ablationPROCEDURE

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

No interventionOTHER

No intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Stent patency

Duration of stent patency over the 6 month follow-up period

Time frame: 6 months

Re-intervention free survival

Duration of re-intervention free survival over the 6 month follow-up period

Time frame: 6 months

Mortality

Number of subject deaths following ERCP, over the 6-month follow-up period

Time frame: 6 months

Secondary Outcomes

Adverse Events

Number of participants with treatment-related adverse events over the 6-month follow-up period

Time frame: 6 months

Time until first adverse event

Time (in days) from ERCP until first treatment-related adverse event, over the 6-month follow-up period

Time frame: 6 months

Data from ClinicalTrials.gov

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