NCT05826639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2024

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

April 12, 2023

Last Update Submit

February 25, 2025

Conditions

Biliary Stricture

Keywords

Bile duct obstructionBiliary stentTemperature-Sensitive Radiofrequency Ablation (RFA)

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Adverse Events

    6 months

  • Time until first adverse event

    6 months

Study Arms (2)

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

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.

Other: No intervention

Interventions

Temperature-sensitive radiofrequency ablationPROCEDURE

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

Also known as: RFA
Temperature-sensitive RFA prior to biliary stenting
No interventionOTHER

No intervention

Non-RFA biliary stenting for malignant biliary obstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that have or will have a biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation (RFA) with placement of biliary stents.

You may qualify if:

  • Malignant biliary stricture
  • participants have or will have a biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation (RFA) with placement of biliary stents
  • Patients with life expectancy greater than 3 months
  • Able to provide consent

You may not qualify if:

  • Patients who are pregnant
  • Patients with cirrhosis
  • Patients with 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 RFA
  • Patients with altered anatomy unable to undergo conventional ERCP (i.e., history of Roux-en-Y gastric bypass)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Cholestasis

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Vinay Chandrasekhara, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 24, 2023

Study Start

April 13, 2023

Primary Completion

November 18, 2024

Study Completion

November 18, 2024

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)