Clinical trial NCT05790109: Operator and Patient Acceptance of Radiofrequency Cautery of the Biopsy Track During Percutaneous Liver, Kidney or Spleen Biopsy Procedures.
Official title: Operator and Patient Acceptance of Radiofrequency Cautery of the Biopsy Track During Percutaneous Liver, Kidney or Spleen Biopsy Procedures.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bleeding Disorder
Spleen Lesion
Liver Diseases
Kidney Diseases
Keywords: Biopsy
Cautery
Bleeding
Liver
Kidney
Spleen
Hemostasis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2023-03-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient experience during use of radiofrequency track cautery during percutaneous organ biopsy
timeFrame: Within 6 hours after procedure
measure: Operator experience during use of radiofrequency track cautery during percutaneous organ biopsy
timeFrame: Within 7 days after procedure
Secondary outcomes:
measure: Technical success rate of radiofrequency track cautery during percutaneous organ biopsy
timeFrame: Within 7 days after procedure
measure: Adverse events of radiofrequency track cautery during percutaneous organ biopsy
timeFrame: Within 30 days after procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Paul B Shyn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.