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: Active, not recruiting

Administrative data

• NCT number: NCT05826639
• Other study ID #: 22-005206
• Status: Active, not recruiting
• Start date: April 13, 2023
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not recruiting
• Enrollment: 500
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• 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

Related Conditions & MeSH terms

• Biliary Stricture
• Constriction, Pathologic

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