Hemostasis Using Radiofrequency Ablation for Track Bleeding

NCT ID: NCT05017350

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiofrequency ablation group

hemostasis using radiofrequency ablation for track bleeding

Group Type EXPERIMENTAL

radiofrequency ablation

Intervention Type PROCEDURE

Under the ultrasound guidance, the electrode is inserted into the bleeding focus of the liver and the bleeding focus is ablated.

Interventions

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radiofrequency ablation

Under the ultrasound guidance, the electrode is inserted into the bleeding focus of the liver and the bleeding focus is ablated.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyoung Doo Song

OTHER

Sponsor Role lead

Responsible Party

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Kyoung Doo Song

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kyoung Doo Song, Professor

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kyoung Doo Song, Professor

Role: CONTACT

82-2-3410-2518

Min Woo Lee, Professor

Role: CONTACT

Facility Contacts

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Kyoung Doo Song, Professor

Role: primary

Other Identifiers

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2021-04-028-003

Identifier Type: -

Identifier Source: org_study_id

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