Hemostasis Using Radiofrequency Ablation for Track Bleeding

Not Applicable

Recruiting

• Conditions: Bleeding
• Interventions: Procedure: radiofrequency ablation

• Registration Number: NCT05017350
• Lead Sponsor: Kyoung Doo Song

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-17
• Last Update Submitted: 2021-08-17
• Study First Posted: 2021-08-23
• Last Update Posted: 2021-08-23
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiofrequency ablation group	radiofrequency ablation	hemostasis using radiofrequency ablation for track bleeding

Primary Outcome Measures

Name	Time	Method
hemostasis rate	immediately after radiofrequency ablation	success rate of hemostasis using radiofrequency ablation on CT taken after radiofrequency ablation

Secondary Outcome Measures

Name	Time	Method
complication rate	immediately after radiofrequency ablation	complication rate associated with radiofrequency ablation on CT taken after radiofrequency ablation

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of