Operator and Patient Acceptance of Radiofrequency Cautery of the Biopsy Track During Percutaneous Liver, Kidney or Spleen Biopsy Procedures.

NCT05790109 | Withdrawn FDA Device

• 1 other identifier: 2022P001476
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess the physician and patient experience of radio frequency (RF) track cautery in patients undergoing needle biopsy of the liver, kidney, or spleen who have one or more risk factors for biopsy-related bleeding. RF track cautery involves inserting a bipolar electrode through the same introducer needle used for the biopsy, and heating the tissues along the path of the biopsy needle to prevent bleeding. This study primarily aims to assess the operator and patient experience during the use of track cautery. Secondary aims are to assess the technical success rate and procedure adverse events. Participants who enroll in the study will undergo track cautery as part of their clinically indicated liver, kidney, or spleen biopsy. After the procedure, they will fill out a brief survey asking about their experience during the procedure. Physician operators who perform track cautery as part of the study will also fill out a survey after each procedure asking about their experience using this technique.

Conditions

Bleeding Disorder; Spleen Lesion; Liver Diseases; Kidney Diseases

Keywords

Biopsy; Cautery; Bleeding; Liver; Kidney; Spleen; Hemostasis

Outcome Measures

Primary Outcomes (2)

• Patient experience during use of radiofrequency track cautery during percutaneous organ biopsy

  Patient experience will be assessed via a questionnaire completed while in the recovery area following their procedure. The patient questionnaire will include questions regarding patient recollection of discomfort related to RF cautery, and whether or not they would be willing to have RF cautery performed again during a future biopsy session, if indicated.

  Within 6 hours after procedure

• Operator experience during use of radiofrequency track cautery during percutaneous organ biopsy

  Operator experience will be assessed via a post-procedure questionnaire (included below) administered to all study operators immediately after they perform each biopsy procedure with RF cautery. The operator questionnaire will consist of a series of questions related to the use of RF cautery, focusing on factors such as ease of use, added procedure time, perceived benefits/detriments, and the operator's perception of associated patient discomfort.

  Within 7 days after procedure

Secondary Outcomes (2)

• Technical success rate of radiofrequency track cautery during percutaneous organ biopsy

  Within 7 days after procedure

• Adverse events of radiofrequency track cautery during percutaneous organ biopsy

  Within 30 days after procedure

Study Arms (1)

RF biopsy track cautery

EXPERIMENTAL

This study is designed as an open-label, single arm study, wherein all study participants will undergo RF track cautery during percutaneous liver, kidney, or spleen biopsy.

Device: RF track cautery during percutaneous organ biopsy

Interventions

RF track cautery during percutaneous organ biopsy DEVICE

After biopsy samples are obtained, the physician operator will place a radiofrequency bipolar cautery electrode through the biopsy introducer needle into the biopsy track and cauterize the track using a standardized protocol.

RF biopsy track cautery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to interventional radiology for clinically indicated liver, kidney, or spleen biopsy for diffuse or focal disease, who also have one or more of the following risk factors for bleeding:
• Coagulopathy (INR ≥ 1.5) or thrombocytopenia (platelets \< 50) before correction
• Renal disease with glomerular filtration rate (GFR) \< 30 ml/min
• Liver cirrhosis
• Anticoagulant or antiplatelet medications where periprocedural withholding poses
• Competing medical risk, or the urgency of the procedure precludes holding the anticoagulant medications for the standard interval (departmental guidelines).
• Any splenic biopsy
• Hypervascular masses in the liver or kidney
• Renal and liver parenchymal biopsies, which are known to carry a higher risk of bleeding.

You may not qualify if:

• Uncorrectable coagulopathy (INR remaining ≥ 2.5) or thrombocytopenia (platelets remaining \< 25)
• Pregnancy
• Patients who are not competent to provide their own consent

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

• Minami Y, Hayaishi S, Kudo M. Radiofrequency ablation for hepatic malignancies: is needle tract cauterization necessary for preventing iatrogenic bleeding? Dig Dis. 2013;31(5-6):480-4. doi: 10.1159/000355254. Epub 2013 Nov 21.

  PMID: 24281024 BACKGROUND

• Laeseke PF, Winter TC 3rd, Davis CL, Stevens KR, Johnson CD, Fronczak FJ, Webster JG, Lee FT Jr. Postbiopsy bleeding in a porcine model: reduction with radio-frequency ablation--preliminary results. Radiology. 2003 May;227(2):493-9. doi: 10.1148/radiol.2272020173. Epub 2003 Apr 3.

  PMID: 12676970 BACKGROUND

• Pritchard WF, Wray-Cahen D, Karanian JW, Hilbert S, Wood BJ. Radiofrequency cauterization with biopsy introducer needle. J Vasc Interv Radiol. 2004 Feb;15(2 Pt 1):183-7. doi: 10.1097/01.rvi.000019398.74740.69.

  PMID: 14963187 BACKGROUND

• Lim S, Rhim H, Lee MW, Song KD, Kang TW, Kim YS, Lim HK. New Radiofrequency Device to Reduce Bleeding after Core Needle Biopsy: Experimental Study in a Porcine Liver Model. Korean J Radiol. 2017 Jan-Feb;18(1):173-179. doi: 10.3348/kjr.2017.18.1.173. Epub 2017 Jan 5.

  PMID: 28096727 BACKGROUND

• Choi SH, Lee JM, Lee KH, Kim SH, Lee JY, Han JK, Choi BI. Postbiopsy splenic bleeding in a dog model: comparison of cauterization, embolization, and plugging of the needle tract. AJR Am J Roentgenol. 2005 Oct;185(4):878-84. doi: 10.2214/AJR.04.1395.

  PMID: 16177404 BACKGROUND

• Song KD, Rhim H, Lee MW, Kang TW, Lim S. A radiofrequency device for tract ablation after liver biopsy: a single-institution human feasibility study. Br J Radiol. 2018 May;91(1085):20170585. doi: 10.1259/bjr.20170585. Epub 2018 Mar 8.

  PMID: 29356562 BACKGROUND

MeSH Terms

Conditions

Hemostatic Disorders; Liver Diseases; Kidney Diseases; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Digestive System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul B Shyn, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 29, 2023
• Study Start: May 23, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 3, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)