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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05790109

Collaborator

Massachusetts General Hospital (Other)

100

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bleeding Disorder Spleen Lesion Liver Diseases Kidney Diseases	Device: RF track cautery during percutaneous organ biopsy	N/A

Detailed Description

Percutaneous biopsies of abdominal organs (liver, kidney, spleen) are commonly performed procedures and, while generally considered safe, have a small risk of post-biopsy hemorrhage. Bleeding risks of percutaneous biopsy are known to be higher for solid abdominal organs including liver, kidney and spleen, than for abdominal biopsies not involving these organs (for example, peritoneal masses or lymph nodes) Some patients also exhibit an increase in bleeding risk due to alterations in coagulation parameters or platelet number and function, which are known to increase rates of post-biopsy hemorrhage. Existing corrective measures for bleeding diathesis such as blood product transfusions are costly and confer additional risks, and do not address the mechanical tissue and vessel injury that sometimes underlies post-biopsy bleeding. Injection of gelatin sponge or other materials into the biopsy track via the introducer needle, while commonly used, can be cumbersome and imprecise, and has not yet clearly demonstrated a benefit in reducing post-biopsy bleeding in human studies.

High-frequency RF cautery, a technique ubiquitous in modern surgical practice, is routinely used for intraoperative hemostasis. This technique is also routinely used during image-guided percutaneous thermal ablation procedures, where the needle track created by the ablation probe is cauterized during probe retraction. An FDA-cleared bipolar RF cautery device that fits through a 17G biopsy introducer needle is now in clinical use, for the purpose of minimizing bleeding during percutaneous image-guided procedures. This study aims to prospectively study the physician and patient experience of using RF track cautery in patients undergoing percutaneous liver, kidney, or spleen biopsy procedures.

Primary aims of the study are:

Determine how the use of radiofrequency (RF) track cautery during percutaneous solid organ biopsy affects operator experience.
Determine how the use of radiofrequency (RF) track cautery during percutaneous solid organ biopsy affects patient experience.

Secondary aims of the study are:

Determine the technical success rate of RF track cautery during percutaneous solid organ biopsy, defined by successful deployment of the cautery electrode through the biopsy introducer needle and application of radiofrequency current to the biopsy track.
Monitor adverse events, such as bleeding, during and after biopsy procedures in which RF track cautery is used.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

Apr 15, 2025

Anticipated Study Completion Date :

Oct 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RF biopsy track cautery 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 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.

Arm

Intervention/Treatment

Experimental: RF biopsy track cautery

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

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.

Outcome Measures

Primary Outcome Measures

Patient experience during use of radiofrequency track cautery during percutaneous organ biopsy [Within 6 hours after procedure]
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.
Operator experience during use of radiofrequency track cautery during percutaneous organ biopsy [Within 7 days after procedure]
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.

Secondary Outcome Measures

Technical success rate of radiofrequency track cautery during percutaneous organ biopsy [Within 7 days after procedure]
Technical success will be defined by successful deployment of the cautery electrode through the introducer needle into the region sampled by the biopsy needle and application of radiofrequency current for the requisite duration. This will be assessed based on a combination of self-reported technical success by the operator as well as retrospective review of the intraprocedural images by the study investigators.
Adverse events of radiofrequency track cautery during percutaneous organ biopsy [Within 30 days after procedure]
Adverse events will be assessed by recording any major and minor adverse events (including bleeding) that occur during or after biopsy procedures where RF cautery was used.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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