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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

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