A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions

Last updated: February 25, 2025
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

N/A

Condition

Gall Bladder Disorders

Treatment

Temperature-sensitive radiofrequency ablation

No intervention

Clinical Study ID

NCT05826639
22-005206
NCI-2024-02188
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Malignant biliary stricture

  • participants have or will have a biopsy-confirmed pancreaticobiliary or ampullarymalignancy that have agreed to undergo radiofrequency ablation (RFA) with placementof biliary stents

  • Patients with life expectancy greater than 3 months

  • Able to provide consent

Exclusion

Exclusion Criteria:

  • Patients who are pregnant

  • Patients with cirrhosis

  • Patients with significant liver metastasis >30% on radiologic imaging suggestiveof poor liver function that will not improve despite endoscopic drainage.

  • Patients who have undergone prior biliary decompression stents or percutaneousdrainage 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 ofRoux-en-Y gastric bypass)

Study Design

Total Participants: 176
Treatment Group(s): 2
Primary Treatment: Temperature-sensitive radiofrequency ablation
Phase:
Study Start date:
April 13, 2023
Estimated Completion Date:
November 18, 2024

Connect with a study center

  • Mayo Clinic Minnesota

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

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