A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions

Active, not recruiting

• Conditions: Biliary Stricture
• Interventions: Procedure: Temperature-sensitive radiofrequency ablation; Other: No intervention

• Registration Number: NCT05826639
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-12
• Study Start: 2023-04-13
• Study First Posted: 2023-04-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Temperature-sensitive RFA prior to biliary stenting	Temperature-sensitive radiofrequency ablation	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.
Non-RFA biliary stenting for malignant biliary obstruction	No intervention	Retrospective participants that have undergone non-RFA biliary stenting for malignant biliary obstruction from a historical cohort will serve as controls.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States