A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05826639
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 20.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Stricture	Procedure: Temperature-sensitive radiofrequency ablation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Risks, Safety, and Outcomes of Temperature-sensitive Endobiliary Radiofrequency Ablation in Patients With Malignant Biliary Obstructions
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Stent patency [6 months]

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

2. Re-intervention free survival [6 months]

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

3. Mortality [6 months]

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

Secondary Outcome Measures

1. Adverse Events [6 months]

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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Vinay Chandrasekhara, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Vinay Chandrasekhara, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05826639
• Other Study ID Numbers: 22-005206
• First Posted: Apr 24, 2023
• Last Update Posted: Apr 25, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vinay Chandrasekhara, Principal Investigator, Mayo Clinic: Bile duct obstruction; Biliary stent; Temperature-Sensitive Radiofrequency Ablation (RFA)
• Additional relevant MeSH terms: Constriction, Pathologic

Study Results

No Results Posted as of Apr 25, 2023