Ultrasound-Guided Percutaneous Biopsy With Needle Track Plugging in Patients With Focal Liver Lesions on an Outpatient Basis: A Randomized Controlled Trial

Abstract

Objective: The increasing utilization of various molecular tests for diagnosing and selecting treatments for patients with malignancies has led to a rising trend in both the frequency of biopsies and the required tissue volume. We aimed to compare the safety of outpatient ultrasound (US)-guided percutaneous liver biopsy (PLB) between the coaxial method with needle track plugging (NTP) and the conventional method.

Materials and methods: This single-center, prospective, randomized controlled study was conducted from October 2022 to May 2023. Patients referred for US-guided PLB with target liver lesions measuring ≥1 cm and requiring ≥3 tissue cores were enrolled. Patients with severe coagulopathy or a substantial volume of ascites were excluded. Patients were randomly assigned to undergo PLB using either the coaxial method with NTP or the conventional method, in a 1:1 ratio, and were subsequently discharged after 2 hours. The primary endpoint was the presence of a patent track sign, defined as a linear color flow along the biopsy track on Doppler US, as an indication of bleeding. The secondary endpoints included clinically significant bleeding, delayed bleeding after discharge, and diagnostic yield. The incidences of these endpoints were compared between the two methods.

Results: A total of 107 patients completed the study protocol. Patent track signs were observed significantly less frequently in the coaxial method with NTP group than in the conventional method group: 16.7% (9/54) vs. 35.8% (19/53; P = 0.042). Clinically significant bleeding and delayed bleeding did not occur in either group, and both methods achieved a high diagnostic yield: 94.4% (51/54) vs. 98.1% (52/53; P = 0.624).

Conclusion: Compared with the conventional method, the coaxial method with NTP may potentially be safer, with a reduced risk of overall bleeding complications after PLB when retrieving ≥3 tissue cores. The coaxial method with NTP could be considered a viable option for acquiring multiple liver tissues on an outpatient basis.

Keywords: Bleeding; Hemorrhage; Image-guided biopsy; Liver; Prospective studies; Ultrasonography, Doppler.

Fig. 1. Patient screening, enrollment, and study protocol. A: Patients with a focal liver lesion >1 cm, deemed feasible for US-guided PLB, and requiring three or more tissue cores were enrolled in the study. All enrolled patients were randomly allocated to one of two biopsy methods: the coaxial method with needle track plugging, which involves a single liver capsule penetration; or the conventional method, which requires three or more liver capsule penetrations. After the biopsy, Doppler US was performed to assess for track bleeding through the presence of a patent track sign, defined as a linear track of color flow along the biopsy track. Patients were discharged after a 2-hour observation period. Follow-up phone calls were made both 1 day and 1 week after the procedure to assess for any signs of delayed bleeding. B: A total of 122 patients were prospectively enrolled and randomized. After the exclusion of patients who withdrew their consent (n = 7), had a focal liver lesion of <1 cm measured on preprocedural US (n = 1), were deemed unfeasible for US-guided biopsy (n = 4), or did not adhere to the allocated protocol (n = 3), the remaining 54 and 53 patients were finally enrolled into the coaxial method with needle track plugging group and the conventional method group, respectively. US = ultrasound, PLB = percutaneous liver biopsy

Fig. 2. Detection and cessation of track bleeding after percutaneous liver biopsy. A: A patent track sign, defined as a linear track of color flow along the biopsy track, was detected on Doppler US performed immediately after a US-guided percutaneous liver biopsy using the coaxial method with needle track plugging. B: The patent track sign disappeared within 1 minute. C: The patent track sign was observed on immediate postbiopsy Doppler US using the conventional method. D: The patent track sign persisted on 5-minute-delay Doppler US. E: The patent track sign disappeared in 8 minutes. US = ultrasound

Fig. 3. Duration of the patent track sign according to the biopsy method. Patent track signs were observed significantly less frequently in the coaxial method with needle track plugging group than the conventional method group. When the patent track sign was present, its duration was shorter in the coaxial method with needle track plugging group than the conventional method group. All patent track signs spontaneously resolved within 30 minutes.