A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions

Study Overview
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Brief Summary
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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.

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

Conditions
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Biliary Stricture

Intervention / Treatment
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* Procedure: Temperature-sensitive radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malignant biliary stricture Biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation with placement of biliary stents Patients with life expectancy greater than 3 months Exclusion Criteria: Patients who are pregnant, have cirrhosis, or 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 radiofrequency ablation Patients with altered anatomy unable to undergo conventional ERCP

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Temperature-sensitive RFA prior to biliary stenting<br>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. | Procedure: Temperature-sensitive radiofrequency ablation<br>* Endobiliary radiofrequency ablation prior to ERCP-guided biliary stenting that utilizes a temperature-sensitive endobiliary RFA catheter<br>* Other names: RFA;|
| Non-RFA biliary stenting for malignant biliary obstruction<br>Retrospective participants that have undergone non-RFA biliary stenting for malignant biliary obstruction from a historical cohort will serve as controls. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants with treatment-related adverse events over the 6-month follow-up period | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bile duct obstruction, Biliary stent, Temperature-Sensitive Radiofrequency Ablation (RFA)