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NCT05826639 Clinical Trial

A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions

Biliary Stricture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05826639
Other study ID # 22-005206
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 13, 2023
Est. completion date November 2024

Study information
Verified date May 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stent patency Duration of stent patency over the 6 month follow-up period 6 months
Primary Re-intervention free survival Duration of re-intervention free survival over the 6 month follow-up period 6 months
Primary Mortality Number of subject deaths following ERCP, over the 6-month follow-up period 6 months
Secondary Adverse Events Number of participants with treatment-related adverse events over the 6-month follow-up period 6 months
Secondary 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
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