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Hemostasis Using Radiofrequency Ablation for Track Bleeding

Primary Purpose

Bleeding

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
radiofrequency ablation
Sponsored by
Kyoung Doo Song
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding focused on measuring liver, track bleeding, radiofrequency ablation

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiofrequency ablation group

Arm Description

hemostasis using radiofrequency ablation for track bleeding

Outcomes

Primary Outcome Measures

hemostasis rate
success rate of hemostasis using radiofrequency ablation on CT taken after radiofrequency ablation

Secondary Outcome Measures

complication rate
complication rate associated with radiofrequency ablation on CT taken after radiofrequency ablation

Full Information

First Posted
August 3, 2021
Last Updated
August 17, 2021
Sponsor
Kyoung Doo Song
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1. Study Identification

Unique Protocol Identification Number
NCT05017350
Brief Title
Hemostasis Using Radiofrequency Ablation for Track Bleeding
Official Title
Hemostasis Using Radiofrequency Ablation for Track Bleeding After Liver Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kyoung Doo Song

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
Keywords
liver, track bleeding, radiofrequency ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency ablation group
Arm Type
Experimental
Arm Description
hemostasis using radiofrequency ablation for track bleeding
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Description
Under the ultrasound guidance, the electrode is inserted into the bleeding focus of the liver and the bleeding focus is ablated.
Primary Outcome Measure Information:
Title
hemostasis rate
Description
success rate of hemostasis using radiofrequency ablation on CT taken after radiofrequency ablation
Time Frame
immediately after radiofrequency ablation
Secondary Outcome Measure Information:
Title
complication rate
Description
complication rate associated with radiofrequency ablation on CT taken after radiofrequency ablation
Time Frame
immediately after radiofrequency ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyoung Doo Song, Professor
Phone
82-2-3410-2518
Email
kd3893.song@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Min Woo Lee, Professor
Email
mw2542.lee@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoung Doo Song, Professor
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyoung Doo Song, Professor
Email
kd3893.song@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Hemostasis Using Radiofrequency Ablation for Track Bleeding

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