This prospective randomized controlled trial was approved by the institutional review board and ethics committee of Sichuan Cancer Hospital. All procedures were performed following informed consent.
Between November 2019 and March 2021, a total of 130 consecutive patients with oral masses were enrolled in this study. Patients were prospectively recruited and randomized (1:1 allocation) to receive transoral approach or transcutaneous approach during US-CNB. Randomization was performed by using computer-generated random numbers (SPSS, version 19.0 for windows, Chicago, IL, USA).
The inclusion criteria were as follows: (1) have been confirmed on surgical resection pathology; (2) willingness and ability to sign informed consent. The exclusion criteria were as follows: (1) uncorrected coagulopathy; (2) severe cardiopulmonary insufficiencies (class III and IV heart failure; recent myocardial infarction; unstable angina; uncontrolled hypertension; right-to-left cardiac shunts; respiratory distress syndrome); (3) allergic to intravenous contrast agent; (4) without subsequent surgical resection and confirmation.
Us Guided Transoral Cnb
US guided transoral CNB was performed by an experienced radiologist (M.L., with 20 years of experience in musculoskeletal US, CEUS and intervention). The patient was positioned in a supine decubitus position after administering local anaesthesia (10ml lidocaine hydrochloride mucilage). After putting on the ultrasonic gel-filled dedicated sterile probe cover, a 10 MHz endocavitary transducer (Philips EPIQ 7 and IU22 ultrasound system, Bothell, WA) or a 5-9 MHz endocavitary transducer (Logiq 9, GE Healthcare, Wauwatosa, WI) was inserted via transoral access. The color Doppler and intravenous contrast-enhanced sonography were performed to identify enhancing viable tissue and avoid adjacent vasculature, nerve, cystic component and necrosis. After activating an electronic biopsy line, the brightly echogenic line was visualized in the sector scan plane. We adjusted the position of the probe to ensure the biopsy line would cross the viable enhancing tissue. Then, a needle guide device was attached to the endocavitary transducer shaft and an eighteen-gauge automatic core biopsy needles (Magnum and Max-Core, Bard, Tempe, AZ, USA) with a 15- or 22-mm-throw were used depending on the size and location of the lesion. After confirming the biopsy route, the 18-gauge automatic biopsy gun was triggered. (Figure 1).
Us Guided Transcutaneous Cnb
US guided transcutaneous CNB was performed by the same experienced radiologist (M.L) from a submental approach. The patient was positioned in a supine decubitus position, and the neck was extended to the extent tolerated. The 5-12 MHz linear probe (Philips EPIQ 7, Bothell, WA) was placed between the hyoid bone and the mandible for visualization of the oral lesions. B mode, color Doppler and intravenous contrast-enhanced sonography were used to evaluate morphological features of oral lesions and the adjacent vasculature, internal vascularity. After aseptic preparation, 2 mL 2% lidocaine was administered at needle puncture site, around the target lesion and along the biopsy path under real-time ultrasound monitoring. After confirming the biopsy route, an 18-gauge automatic core biopsy needle (Magnum and Max-Core, Bard, USA) with the 15mm or 22-mm-throw was inserted into the skin in a parallel fashion under ultrasound guidance and fired sequentially (Figure 1).
Three specimens were routinely obtained for each biopsy. A specimen was considered adequate if it was longer than 0.5 cm14. The specimen was fixed in 10% neutral buffered formalin for pathological examination after needle withdrawal.
After the biopsy, clinical follow-up was performed. Manual compression of the puncture with fixed size gauze of 3 minutes was request and the patient was discharged after being closely observed for 1 hour. Intra‑operative blood loss volume was estimated by visual estimation15. The thoroughly soaked gauze (4 inches × 4 inches) was taken as containing 10 ml of blood, and gauze pieces not thoroughly soaked (1cm2 of gauze was assumed to contain 0.1 ml of blood) were estimated in consensus by two investigators (T.W., and X.C.) blinded to procedure. Oral pain after the biopsy was evaluated using the VAS score. The biopsy time (defined as the time from the first puncture to the removal of the final puncture) for all biopsies were recorded. Routine postprocedural ultrasound imaging was performed to demonstrate the presence of postprocedural hematoma, acute submandibular sialadenitis and other delayed complications.
All data analysis was performed by using SPSS 19.0 (SPSS Inc., Chicago, IL, USA). Post hoc power analysis using interactive software (PS: Power and Sample Size Calculation, version 3.0, 2009) with power of 0.8 and significance set at a = .05 (type I error, two tailed) was used to determine the sample size. Post hoc power analysis revealed that our sample size was adequate. Quantitative variables were expressed as mean ± standard deviation (mean ± SD). Categoric variables were expressed as frequencies or percentages. The diagnostic sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy (the number of cases correctly diagnosed divided by the total number of each group) of the two groups were assessed by testing against surgical excision results. Postprocedural complication rate for patients was compared between two groups. The significances of the difference between the two groups were evaluated by using an independent sample T-test in case of normally distributed data and Wilcoxon rank sum test in case of data that was not normally distributed. Comparisons of categorical variables for two groups was used by using Pearson Chi-square test and Fisher’s exact test. P values < 0.05 were considered to indicate a significant difference.