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Completed

NCT Number: NCT05826639

A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions

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.

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Key information

Conditions

Biliary Stricture Bile Duct Diseases Biliary Tract Diseases Cholestasis Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Temperature-sensitive radiofrequency ablation

Procedure

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

Other names: RFA

No intervention

Other

No intervention

Primary outcomes

  1. Stent patency

    Time frame: 6 months

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

  2. Re-intervention free survival

    Time frame: 6 months

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

  3. Mortality

    Time frame: 6 months

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

Secondary outcomes

  1. Adverse Events

    Time frame: 6 months

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

  2. Time until first adverse event

    Time frame: 6 months

    Time (in days) from ERCP until first treatment-related adverse event, over the 6-month follow-up period

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2023
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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