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NCT05017350 Clinical Trial

Hemostasis Using Radiofrequency Ablation for Track Bleeding

Bleeding Clinical Trial

Official title:
Hemostasis Using Radiofrequency Ablation for Track Bleeding After Liver Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05017350
Other study ID # 2021-04-028-003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date December 31, 2024

Study information
Verified date August 2021
Source Samsung Medical Center
Contact Kyoung Doo Song, Professor
Phone 82-2-3410-2518
Email kd3893.song@samsung.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the usefulness of hemostasis using radiofrequency ablation for track bleeding that has occurred after percutaneous biopsy of the liver.

Description:

Purpose: To evaluate the usefulness of hemostasis using radiofrequency ablation for track bleeding after percutaneous liver biopsy. Method: - Enroll patients who continue to bleed despite conservative treatment for track bleeding that has occurred after liver biopsy. - Radiofreqeuncy ablation: Under monitoring vital signs and controlling pain with intravenous agents, the electrode is inserted into the bleeding focus. The bleeding focus is ablated. - Hemostasis is evaluated by ultrasound (right after radiofrequency ablation), CT scan (after the radiofrequency ablation), and ultrasound (the day after radiofrequency ablation) - If hemostasis fails using radiofrequency ablation, transarterial hepatic embolization is performed immediately.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility Inclusion Criteria: - Ultrasound guided percutaneous liver biopsy at Samsung Medical Center - Track bleeding after biopsy - Persistent track bleeding even after conservative management - Consent to this study Exclusion Criteria: - Not consent to this study - <20 years old or >=80 years old - Contraindication to radiofrequency ablation - Radiofrequency ablation for track bleeding is not technically possible. - Unstable vital signs

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• radiofrequency ablation
Under the ultrasound guidance, the electrode is inserted into the bleeding focus of the liver and the bleeding focus is ablated.

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Kyoung Doo Song

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary hemostasis rate success rate of hemostasis using radiofrequency ablation on CT taken after radiofrequency ablation immediately after radiofrequency ablation
Secondary complication rate complication rate associated with radiofrequency ablation on CT taken after radiofrequency ablation immediately after radiofrequency ablation
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